Examples: breast cancer, NCT03147287, pd-l1

Top 100 results for: "metastatic breast cancer"

Enrolling

Phase 1/2, Multicenter, Open-Label, Multiple Dose, First-In-Human Study of U3-1402, in Subjects with HER3 Positive Metastatic Breast Cancer

Trial Description: This is an open-label, three-part, multiple-dose study to evaluate safety, tolerability, and efficacy of U3-1402 in patients with HER3-positive metastatic breast cancer. HER3 is a unique member of the human epidermal growth factor receptor, which defines a certain type of cancer. The number of patients and treatment cycles are not fixed in this study. Subjects who continue to derive clinical benefit from the study treatment in the absence of withdrawal of consent, progressive disease (PD), unacceptable toxicity, or death may continue the study treatment until the end of the trial.

  • Conditions: metastatic breast cancer
  • Phase: I/II
  • Trial ID: NCT02980341
  • Protocol ID: 18-382

Enrolling

Palbociclib After CDK and Endocrine Therapy (PACE): A Randomized Phase II Study of Fulvestrant, Palbociclib, and Avelumab for Endocrine Pre-treated ER+/HER2- Metastatic Breast Cancer

Trial Description: This research study is studying three combinations of drugs as treatments for breast cancer. The drugs involved in this study are: - Fulvestrant - Fulvestrant with Palbociclib - Fulvestrant with Palbociclib and Avelumab

  • Conditions: metastatic breast cancer
  • Phase: II
  • Trial ID: NCT03147287
  • Protocol ID: 17-101

Not Enrolling

An Open Label, Phase II Trial of Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Using Verteporfin (Visudyne®) for the Treatment of Cutaneous Metastases of Breast Cancer

Trial Description: The purpose of this Phase II study is to evaluate the efficacy and safety of Continuous Low- Irradiance Photodynamic Therapy (CLIPT) when used with Verteporfin in the treatment of cutaneous metastases of breast cancer for which no curative or significantly palliative therapy exists, including chest wall therapy.

  • Conditions: metastatic breast cancer
  • Phase: II
  • Trial ID: NCT02939274
  • Protocol ID: 16-370

Not Enrolling

A Phase 1b Study of Aurora A Kinase Inhibitor LY3295668 erbumine in Monotherapy and Combination Therapy in Patients with Metastatic Breast Cancer post CDK4/6 Inhibitor and Endocrine Therapy

Trial Description: The reason for this study is to determine the recommended phase 2 dose of the study drug LY3295668 erbumine in participants with breast cancer that has spread to other parts of the body.

  • Conditions: metastatic breast cancer
  • Phase: I
  • Trial ID: NCT03955939
  • Protocol ID: 19-314

Not Enrolling

Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in subjects with Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor2(HER2)Negative Metastatic Breast Cancer(MBC) who have failed at least two prior chemotherapy regimens

Trial Description: The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).

  • Conditions: metastatic breast cancer
  • Phase: III
  • Trial ID: NCT03901339
  • Protocol ID: 19-225

Not Enrolling

A phase 1, open-label, dose-escalation study to evaluate the safety and tolerability of SGN-LIV1A in patients with metastatic breast cancer.

Trial Description: This study will examine the safety and tolerability of ladiratuzumab vedotin (LV) in patients with metastatic breast cancer. LV will be given alone or in combination with trastuzumab.

  • Conditions: breast cancer
  • Phase: I
  • Trial ID: NCT01969643
  • Protocol ID: 14-306

Enrolling

A Phase II Non-randomized Study to Assess the Safety and Efficacy of the Combination of Tucatinib and Trastuzumab and Capecitabine for Treatment of Leptomeningeal Metastases in HER2 Positive Breast Cancer

Trial Description: A phase 2 non-randomized study to assess the safety and efficacy of the combination of tucatinib and trastuzumab with capecitabine for the treatment of leptomeningeal metastases in HER2-neu positive breast cancer.

  • Conditions: leptomeningeal disease, metastatic breast cancer
  • Phase: II
  • Trial ID: NCT03501979
  • Protocol ID: 19-387

Enrolling

A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination with Abemaciclib to Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer and Other Select Non-Breast Cancers

Trial Description: The reason for this study is to see if the study drug LY3484356 alone or in combination with other anticancer therapies is safe and effective in participants with advanced or metastatic breast cancer or endometrial cancer.

  • Conditions: advanced breast cancer, breast cancer, endometrial cancer, metastatic breast cancer
  • Phase: I
  • Trial ID: NCT04188548
  • Protocol ID: 20-118

Not Enrolling

A Phase 1b study of pembrolizumab in combination with trastuzumab-DM1 in metastatic HER2-positive breast cancer

Trial Description: This research study is studying a combination of drugs as a possible treatment for metastatic breast cancer. The interventions involved in this study are: - Pembrolizumab - Trastuzumab emtansine (also called T-DM1)

  • Conditions: breast cancer
  • Phase: I
  • Trial ID: NCT03032107
  • Protocol ID: 16-492

Enrolling

A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)

Trial Description: This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.

  • Conditions: advanced or metastatic breast cancer
  • Phase: III
  • Trial ID: NCT04494425
  • Protocol ID: 20-536

Not Enrolling

A Phase 1b Study of Abemaciclib in Combination with Therapies for Patients with Metastatic Breast Cancer

Trial Description: This study evaluates the safety of abemaciclib in combination therapies (letrozole, anastrozole, tamoxifen, exemestane, exemestane plus everolimus, trastuzumab, LY3023414 plus fulvestrant, pertuzumab plus trastuzumab with loperamide, or ongoing endocrine therapy) for breast cancer that has spread to other parts of the body.

  • Conditions: breast neoplasms
  • Phase: I
  • Trial ID: NCT02057133
  • Protocol ID: 14-070

Enrolling

Pilot Study of the Impact of a Combined Intermittent Fasting and Exercise Intervention on Metabolic Markers in Patients with Advanced, Hormone Receptor Positive Breast Cancer

Trial Description: This research is evaluating the impact of a 12-week prolonged nightly fasting (POF) and exercise intervention on metabolic markers and patient reported outcomes in women with metastatic breast cancer (MBC) initiating endocrine therapy in combination with palbociclib or alpelisib.

  • Conditions: breast cancer, metastatic breast cancer
  • Phase: Feasibility / Pilot
  • Trial ID: NCT04708860
  • Protocol ID: 20-503

Enrolling

A Phase 2 Study of TAS-120 in Metastatic Breast Cancers Harboring Fibroblast Growth Factor Receptor (FGFR) Amplifications

Trial Description: The purpose of this open-label, nonrandomized, Phase 2 study is to evaluate the efficacy and safety of TAS-120 and TAS-120 + fulvestrant in patients with locally advanced/metastatic breast cancer harboring FGFR gene amplifications.

  • Conditions: fgfr2 amplification, metastatic breast cancer
  • Phase: II
  • Trial ID: NCT04024436
  • Protocol ID: 19-844

Not Enrolling

A Phase 2 Study of abemaciclib for Patients with Retinoblastoma Positive, Triple-Negative Metastatic Breast Cancer

Trial Description: This research study is studying a drug called Abemaciclib as a possible treatment for have metastatic triple-negative type of breast cancer.

  • Conditions: breast cancer
  • Phase: II
  • Trial ID: NCT03130439
  • Protocol ID: 17-024

Not Enrolling

A two-part Phase I, open label, dose escalation study to evaluate the safety, tolerability and pharmacokinetics of pyrotinib in patients with HER2-positive solid tumors whose disease progressed on prior HER2 targeted therapy

Trial Description: Part 1: to assess the safety and tolerability of pyrotinib and to define the maximum tolerated dose (MTD) of pyrotinib in patients with Human Epidermal Growth Factor Receptor 2 (HER2)-positive advanced solid tumors (metastatic breast cancer, gastric cancer, or other solid tumors that have no targeted agent as standard of care). Part 2: to estimate the overall response rate (ORR) for patients with HER2-positive metastatic breast cancer (mBC) and HER2 mutant non-small cell lung cancer (NSCLC) treated at the RP2D (or MTD).

  • Conditions: breast cancer, gastric cancer, nsclc, solid tumors
  • Phase: I
  • Trial ID: NCT02500199
  • Protocol ID: 16-265

Not Enrolling

FDG PET to Assess Therapeutic Response in Patients with Bone-dominant Metastatic Breast Cancer, FEATURE

Trial Description: This phase II trial studies how well FDG-PET/CT works in assessing the response of patients with breast cancer that has spread to the bones or mostly to the bones (bone-dominant metastatic breast cancer). Diagnostic procedures, such as FDG-PET/CT, may work better in measuring breast cancer activity before and after treatment compared to other standard imaging tests.

  • Conditions: anatomic stage iv breast cancer ajcc v8, hormone receptor positive breast carcinoma, metastatic breast carcinoma, prognostic stage iv breast cancer ajcc v8
  • Phase: II
  • Trial ID: NCT04316117
  • Protocol ID: 20-430

Enrolling

A phase II study of atezolizumab in combination with pertuzumab plus high-dose trastuzumab for the treatment of central nervous system metastases in patients with Her2-positive breast cancer

Trial Description: This research study is studying a drug called atezolizumab as a possible treatment HER2-positive metastatic breast cancer (MBC) that has spread to the brain. The names of the study drugs involved in this study are: - Atezolizumab - Pertuzumab - Trastuzumab

  • Conditions: central nervous system metastases, her2-positive metastatic breast cancer
  • Phase: II
  • Trial ID: NCT03417544
  • Protocol ID: 17-546

Not Enrolling

A Multicenter, Phase 2 Study of Tesetaxel plus Three Different PD-(L)1 Inhibitors in Patients with Triple-Negative, Locally Advanced or Metastatic Breast Cancer and Tesetaxel Monotherapy in Elderly Patients with HER2 Negative, Locally Advanced or Metastatic Breast Cancer

Trial Description: CONTESSA TRIO is a multi-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane, in patients with metastatic breast cancer (MBC). In Cohort 1, approximately 200 patients with triple-negative MBC who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel plus either: (1) nivolumab; (2) pembrolizumab; or (3) atezolizumab. The primary efficacy endpoints for Cohort 1 are objective response rate (ORR) and progression free survival (PFS) in patients with programmed death-ligand 1 (PD-L1

  • Conditions: breast cancer
  • Phase: II
  • Trial ID: NCT03952325
  • Protocol ID: 19-170

Not Enrolling

Phase Ib dose-escalation trial of Taselisib (GDC-0032) in combination with anti-HER2 therapies in participants with advanced HER2+ Breast Cancer

Trial Description: This research study is a way of gaining new knowledge about the combination of Taselisib with other drugs in the treatment of metastatic breast cancer. Taselisib is an investigational drug which works by blocking a protein called PI3K (phosphoinositide 3-kinase) that helps cancer cells grow. This drug has been used in laboratory experiments and information from these studies suggests that this drug may help to prevent or slow the growth of cancer cells. The main purpose of this study is to find the appropriate dose of Taselisib to be used with other drugs in further clinical studies. This is an open-label, 3+3 dose-escalation phase Ib study to identify the Maximum Tolerated Dose(s) (MTD) and to identify the recommended phase 2 dose (RP2D) of Taselisib. This study will be conducted in 4 separate arms. (A-D).

  • Conditions: metastatic breast cancer, recurrent breast cancer
  • Phase: I
  • Trial ID: NCT02390427
  • Protocol ID: 15-024

Enrolling

A PHASE IB/III STUDY OF IPATASERTIB PLUS PALBOCICLIB AND FULVESTRANT VERSUS PLACEBO PLUS PALBOCICLIB AND FULVESTRANT IN HORMONE RECEPTOR POSITIVE AND HER2 NEGATIVE LOCALLY ADVANCED UNRESECTABLE OR METASTATIC BREAST CANCER

Trial Description: The open-label Phase Ib portion of this study will evaluate the safety and pharmacokinetics of ipatasertib in combination with palbociclib and fulvestrant to identify a dose of ipatasertib that can be combined with palbociclib and fulvestrant in the Phase III portion. The randomized Phase III portion of this study will evaluate the efficacy, safety, and patient-reported outcome (PRO) objectives of ipatasertib + palbociclib + fulvestrant compared with placebo + palbociclib + fulvestrant in patients with HR+ HER2-, locally advanced unresectable or metastatic breast cancer who had relapsed during adjuvant endocrine therapy or progressed during the initial 12 months of first-line endocrine therapy in locally advanced unresectable or metastatic breast cancer.

  • Conditions: breast cancer
  • Phase: III
  • Trial ID: NCT04060862
  • Protocol ID: 19-602

Not Enrolling

A Phase 2 Study of Neratinib with or without Fulvestrant in HER2-Positive, ER-Positive Metastatic Breast Cancer

Trial Description: This research study is studying a drug called Neratinib with and without Fulvestrant as possible treatments for HER2-positive breast cancer . The interventions involved in this study are: - Neratinib and Fulvestrant - Neratinib alone

  • Conditions: breast cancer
  • Phase: II
  • Trial ID: NCT03289039
  • Protocol ID: 17-318

Enrolling

A Phase 2, Open-Label Study to Evaluate the Safety and Antitumor Activity of CX-2009 in Advanced HR-Positive/HER2-Negative Breast Cancer and of CX-2009 as Monotherapy and in Combination with CX-072 in Advanced Triple-Negative Breast Cancer (CTMX-2009-002)

Trial Description: A Phase 2, clinical study in advanced, metastatic breast cancer that will evaluate CX-2009 monotherapy in both Hormone Receptor(HR) positive/HER2 negative breast cancer and in TNBC, and evaluate CX-2009+CX-072 in TNBC

  • Conditions: breast cancer, breast neoplasms, breast neoplasms hormone receptor positive/her2 negative, breast neoplasms triple-negative, neoplasms
  • Phase: II
  • Trial ID: NCT04596150
  • Protocol ID: 21-130

Not Enrolling

Randomized, Open Label, Phase III Trial to Evaluate the Efficacy and Safety of Palbociclib + Anti-HER2 Therapy + Endocrine Therapy vs. Anti-HER2 Therapy + Endocrine Therapy after Induction Treatment for Hormone Receptor Positive (HR+)/HER2-Positive Metastatic Breast Cancer

Trial Description: The primary objective of this study is to demonstrate that the combination of palbociclib with anti-HER2 therapy plus endocrine therapy is superior to anti-HER2-based therapy plus endocrine therapy alone in improving the outcomes of subjects with hormone receptor-positive, HER2+ metastatic breast cancer.

  • Conditions: estrogen receptor positive breast cancer, her-2 positive breast cancer
  • Phase: III
  • Trial ID: NCT02947685
  • Protocol ID: 17-220

Not Enrolling

A Phase 1b Study of Safety and Immune Response to PVX-410 Vaccine Alone and in Combination with Pembrolizumab in HLA-A2+ Patients with Metastatic Triple Negative Breast Cancer (TNBC)

Trial Description: This research study is studying immunotherapy as a possible treatment for metastatic Triple Negative Breast Cancer (TNBC) in participants who are HLA-A2+. The drugs involved in this study are: - PVX-410 - Pembrolizumab - Hiltonol - Montanide

  • Conditions: metastatic breast cancer, triple negative breast cancer
  • Phase: I
  • Trial ID: NCT03362060
  • Protocol ID: 17-328

Enrolling

Randomized phase II study of sacituzumab govitecan with or without pembrolizumab in hormone receptor-positive (HR+) / HER2- metastatic breast cancer (MBC)

Trial Description: This research study is evaluating the safety and effectiveness of Sacituzumab Govitecan with or without Pembrolizumab in metastatic HR+/HER2- breast cancer. The names of the study interventions involved in this study are: - Sacituzumab govitecan (IMMU-132) - Pembrolizumab (Keytruda®; MK-3475)

  • Conditions: her2-negative breast cancer, hr-positive breast cancer, invasive breast cancer, metastatic breast cancer
  • Phase: II
  • Trial ID: NCT04448886
  • Protocol ID: 20-153

Enrolling

A Phase 2 Study of Olaparib Monotherapy in Metastatic Breast Cancer Patients with Germline or Somatic Mutations in DNA Repair Genes (Olaparib Expanded)

Trial Description: This research study is for patients with metastatic breast cancer. - Metastatic means that the cancer has spread beyond the breast. In addition, through genetic testing of the blood or tumor, an altered gene has been found that suggests the tumor may not be able to repair its genetic material (DNA) when it becomes damaged. - This aspect of the cancer may cause it to be more sensitive - that is, more effectively killed by certain types of drugs such as the study agent being evaluated in this trial, Olaparib. - Olaparib is a type of drug known as a PARP inhibitor. Some types

  • Conditions: atm gene mutation, brip1 gene mutation, chek2 gene mutation, invasive breast cancer, metastatic breast cancer, nbn gene mutation, palb2 gene mutation, rad51 gene mutation, somatic mutation breast cancer (brca1), somatic mutation breast cancer (brca2)
  • Phase: II
  • Trial ID: NCT03344965
  • Protocol ID: 17-428

Not Enrolling

A PHASE 3 OPEN-LABEL, RANDOMIZED, MULTICENTER STUDY OF NKTR-102 VERSUS TREATMENT OF PHYSICIAN’S CHOICE (TPC) IN PATIENTS WITH METASTATIC BREAST CANCER WHO HAVE STABLE BRAIN METASTASES AND HAVE BEEN PREVIOUSLY TREATED WITH AN ANTHRACYCLINE, A TAXANE, AND CAPECITABINE

Trial Description: This is an open-label, randomized, active comparator, multicenter, international Phase 3 study of NKTR-102 versus TPC in patients with metastatic breast cancer who have stable brain metastases and have been previously treated with an anthracycline, a taxane, and capecitabine in either the adjuvant or metastatic setting (prior anthracycline may be omitted if medically appropriate or contraindicated for the patient).

  • Conditions: breast cancer, metastasis
  • Phase: III
  • Trial ID: NCT02915744
  • Protocol ID: 16-553

Not Enrolling

A Phase 1b/2a Study Of Palbociclib In Combination With Everolimus And Exemestane In Postmenopausal Women With Estrogen Receptor Positive and HER2 Negative Metastatic Breast Cancer.

Trial Description: This research study is studying a combination of targeted therapy and hormonal therapy as a possible treatment for breast cancer that has spread to other places in the body and is hormone receptor positive (HR+) and HER2-negative. The names of the study interventions involved in this study are: - Palbociclib - Everolimus - Exemestane

  • Conditions: hormone receptor (hr)-positive breast cancer, human epidermal growth factor 2 negative carcinoma of breast
  • Phase: I/II
  • Trial ID: NCT02871791
  • Protocol ID: 16-177

Enrolling

Screening MRI of the brain in patients with metastatic breast cancer managed with first/second line chemotherapy or inflammatory breast cancer managed with definitive intent: A prospective study

Trial Description: This research study is studying the usefulness of magnetic resonance imaging (MRI) to screen for brain metastases (spread of the breast cancer to the brain).

  • Conditions: breast cancer, her2-positive breast cancer, hormone receptor positive malignant neoplasm of breast, inflammatory breast cancer, metastatic breast cancer, triple negative breast cancer
  • Phase: II
  • Trial ID: NCT04030507
  • Protocol ID: 19-066

Enrolling

A Phase 1/2, open-label, dose escalation, and cohort expansion clinical trial to evaluate the safety, tolerability, and pharmacokinetics of ARV-471 in patients with ER+/HER2- locally advanced or metastatic breast cancer, who have received prior hormonal therapy and chemotherapy in the locally advanc

Trial Description: This is a Phase 1/2 dose escalation and cohort expansion study and will assess the safety and tolerability of ARV-471 alone and in combination with palbociclib (IBRANCE®) in patients with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer, who have received prior hormonal therapy and chemotherapy in the locally advanced/metastatic setting.

  • Conditions: breast cancer
  • Phase: I/II
  • Trial ID: NCT04072952
  • Protocol ID: 20-449

Not Enrolling

A Multinational, Multicenter, Phase 2 Study of Tesetaxel plus a Reduced Dose of Capecitabine in Patients with HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received a Taxane

Trial Description: CONTESSA 2 is a multinational, multicenter, Phase 2 study of tesetaxel in patients with HER2 negative, HR positive, locally advanced or metastatic breast cancer (LA/MBC) not previously treated with a taxane. The primary objective of the study is to establish the efficacy of tesetaxel plus a reduced dose of capecitabine based on objective response rate (ORR) as assessed by an Independent Radiologic Review Committee (IRC). 152 patients were enrolled.

  • Conditions: breast cancer
  • Phase: II
  • Trial ID: NCT03858972
  • Protocol ID: 19-221

Not Enrolling

A Phase II Trial Assessing the Tolerability of Palbociclib in Combination with Letrozole or Fulvestrant in Patients Aged 70 and Older with Estrogen Receptor-Positive, HER2-Negative Metastatic Breast Cancer

Trial Description: This phase II trial studies the side effects and how well palbociclib and letrozole or fulvestrant works in treating patients aged 70 years and older with estrogen receptor positive, HER2 negative breast cancer that has spread to other places in the body. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as letrozole or fulvestrant, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving palbociclib and letrozole or fulvestrant may work better in treating patients with breast cancer. The trial will explore factors other than chronologic age that can affect toxicity rates as identified using a cancer-specific geriatric assessment.

  • Conditions: estrogen receptor-positive breast cancer, her2/neu negative, stage iv breast cancer ajcc v6 and v7
  • Phase: II
  • Trial ID: NCT03633331
  • Protocol ID: 18-739

Not Enrolling

A Randomized, Double-Blind, Placebo-Controlled,Phase 3 Study of Fulvestrant with or without Abemaciclib, a CDK4/6 Inhibitor, for Women with Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer

Trial Description: The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib + fulvestrant or fulvestrant alone. Participants will be randomized to abemaciclib or placebo in a 2:1 ratio. The study will last about 9 months for each participant. For the endocrine naïve cohort, all participants will received abemaciclib + fulvestrant.

  • Conditions: breast neoplasms
  • Phase: III
  • Trial ID: NCT02107703
  • Protocol ID: 14-518

Enrolling

AVIATOR: A randomized, phase II study comparing trastuzumab and vinorelbine in combination with avelumab or avelumab and utomilumab (41BB/CD137 agonist), in patients with HER2-positive metastatic breast cancer who have progressed on prior trastuzumab and pertuzumab

Trial Description: This research study is studying a combination of drugs as a possible treatment for breast cancer. The drugs involved in this study are: - Group A: Trastuzumab (Herceptin) + Vinorelbine (Navelbine) - Group B: Trastuzumab + Vinorelbine + Avelumab - Group C: Trastuzumab + Vinorelbine + Avelumab + Utomilumab (PF-05082566)

  • Conditions: breast cancer
  • Phase: II
  • Trial ID: NCT03414658
  • Protocol ID: 17-455

Enrolling

A Phase 1/2 Dose Escalation, Safety, Pharmacokinetics, and Efficacy Study of NUV-422 in Adults with Recurrent or Refractory High-grade Gliomas and Solid Tumors

Trial Description: NUV-422-02 is a first-in-human, open-label, Phase 1/2 dose escalation and multiple expansion cohort study designed to evaluate the safety and efficacy of NUV-422. The study population is comprised of adults with recurrent or refractory high-grade gliomas (HGGs), metastatic breast cancer (mBC), with and without brain metastases, and recurrent or refractory metastatic castration-resistant prostate cancer (mCRPC). All patients will self-administer NUV-422 orally in 28-day cycles until disease progression, toxicity, withdrawal of consent, or termination of the study.

  • Conditions: breast cancer, breast carcinoma, breast tumor, cancer of breast, cancer of prostate, cancer of the breast, cancer of the prostate, glial cell tumors, glioma, glioma malignant, glioma mixed, malignant tumor of breast, prostate cancer, prostate neoplasm, prostatic cancer
  • Phase: I/II
  • Trial ID: NCT04541225
  • Protocol ID: 20-517

Not Enrolling

A Multinational, Multicenter, Randomized, Phase 3 Study of Tesetaxel plus a Reduced Dose of Capecitabine versus Capecitabine Alone in Patients with HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated with a Taxane

Trial Description: CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting. The primary objective of the study is to compare the efficacy of tesetaxel plus a reduced dose of capecitabine versus the approved dose of capecitabine alone based on progression-free survival (PFS) as assessed by the Independent Radiologic Review Committee (IRC). 685 patients were enrolled

  • Conditions: breast cancer
  • Phase: III
  • Trial ID: NCT03326674
  • Protocol ID: 18-547

Not Enrolling

A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED TRIAL OF DS-8201A, AN ANTI-HER2-ANTIBODY DRUG CONJUGATE (ADC), VERSUS TREATMENT OF PHYSICIAN'S CHOICE FOR HER2-LOW, UNRESECTABLE AND/OR METASTATIC BREAST CANCER SUBJECTS

Trial Description: This study will compare DS-8201a to physician choice standard treatment. Participants must have HER2-low breast cancer that has been treated before. Participants' cancer: - Cannot be removed by an operation - Has spread to other parts of the body

  • Conditions: breast cancer
  • Phase: III
  • Trial ID: NCT03734029
  • Protocol ID: 18-663

Not Enrolling

A PHASE 1/2, OPEN-LABEL, MULTICENTER STUDY OF THE COMBINATION OF NKTR-214 AND NIVOLUMAB OR THE COMBINATION OF NKTR-214, NIVOLUMAB, AND OTHER ANTI-CANCER THERAPIES IN PATIENTS WITH SELECT LOCALLY ADVANCED OR METASTATIC SOLID TUMOR MALIGNANCIES

(UC), metastatic Breast Cancer (mBC) and Colorectal Cancer (CRC). In addition, in Part 2, the RP2D of NKTR-214 with nivolumab and various chemotherapies and regimens in select cohorts of NSCLC patients will be determined. In Part 3, several different regimens of the triplet combination of NKTR-214 plus nivolumab and ipilimumab will be evaluated in select patients with RCC, NSCLC, Melanoma, and UC. In Part 4, the safety and efficacy of the triplet combination will be evaluated further in select patients with RCC, NSCLC, Melanoma and UC.

  • Conditions: colorectal cancer, melanoma, metastatic breast cancer, non small cell lung cancer, renal cell carcinoma, urothelial carcinoma
  • Phase: I/II
  • Trial ID: NCT02983045
  • Protocol ID: 17-310

Not Enrolling

An open-label randomized Phase 2 trial of SAR439859, versus endocrine monotherapy as per physician’s choice in premenopausal and postmenopausal patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer with prior exposure to hormonal therapies

Trial Description: Primary Objective: To determine whether amcenestrant per os improves progression free survival (PFS) when compared with a endocrine monotherapy of the choice of the physician, in participants with metastatic or locally advanced breast cancer Secondary Objectives: - To compare the overall survival in the 2 treatment arms - To assess the objective response rate in the 2 treatment arms - To evaluate the disease control rate in the 2 treatment arms - To evaluate the clinical benefit rate in the 2 treatment arms - To evaluate the duration of response in the 2 treatment arms - To evaluate the PFS according to the estrogen receptor 1 gene (ESR1) mutation status in the 2 treatment arms - To evaluate the pharmacokinetics of amcenestrant as single agent - To evaluate health related quality of life in the 2 treatment arms - To compare the overall safety profile in the 2 treatment arms

  • Conditions: breast cancer metastatic
  • Phase: II
  • Trial ID: NCT04059484
  • Protocol ID: 19-391

Not Enrolling

A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED STUDY OF TRASTUZUMAB DERUXTECAN (DS-8201A), AN ANTIHER2-ANTIBODY DRUG CONJUGATE, VERSUS TREATMENT OF INVESTIGATOR’S CHOICE FOR HER2-POSITIVE, UNRESECTABLE AND/OR METASTATIC BREAST CANCER SUBJECTS PREVIOUSLY TREATED WITH T-DM1

Trial Description: This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: - cannot be removed by an operation - has spread to other parts of the body

  • Conditions: breast cancer
  • Phase: III
  • Trial ID: NCT03523585
  • Protocol ID: 18-500

Enrolling

Phase 1/2a Dose Escalation and Expansion Study Evaluating Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Anti-Tumor Activity of PF-06873600 as a Single Agent and in Combination with Endocrine Therapy

Trial Description: Open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamics and clinical activity study of PF-06873600 administered as a single agent and then in combination with endocrine therapy. The study contains two parts, a Part 1 single agent dose escalation and combination endocrine therapy dose finding component and a Part 2 dose expansion in combination with endocrine therapy

  • Conditions: hr+ her2- metastatic breast cancer ovarian cancer fallopian tube cancer primary peritoneal cancer triple negative breast cancer male breast cancer
  • Phase: I/II
  • Trial ID: NCT03519178
  • Protocol ID: 19-676

Enrolling

A Phase IB/II, 2-Stage, Open-label, Multicenter Study to Determine the Efficacy and Safety of Durvalumab (MEDI4736) + Paclitaxel and Durvalumab (MEDI4736) in Combination With Novel Oncology Therapies With or Without Paclitaxel for First-line Metastatic Triple Negative Breast Cancer

Trial Description: This study is designed to determine the efficacy and safety of durvalumab in combination with novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel for first-line metastatic triple negative breast cancer

  • Conditions: triple negative breast neoplasms
  • Phase: I/II
  • Trial ID: NCT03742102
  • Protocol ID: 21-198

Enrolling

Phase 1b/2 Study to Evaluate Safety and Anti-Tumor Activity of Antibody-Drug Conjugate Sacituzumab Govitecan in Combination with the Poly (Adenosine Diphosphate [ADP]-Ribose) Polymerase (PARP) Inhibitor Talazoparib in Patients with Metastatic Triple-Negative Breast Cancer

Trial Description: This research is studying the effect of Antibody-Drug Conjugate Sacituzumab Govitecan in Combination with the Poly (Adenosine Diphosphate [ADP]-Ribose) Polymerase (PARP) Inhibitor Talazoparib in Patients with Metastatic Triple-Negative Breast Cancer.

  • Conditions: breast cancer
  • Phase: I/II
  • Trial ID: NCT04039230
  • Protocol ID: 19-239

Enrolling

A Single Arm, Open Label Phase 2 Study of Tucatinib in Combination with Trastuzumab Deruxtecan in Subjects with Previously Treated Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer

Trial Description: This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan. It will also look at what side effects happen when these drugs are given together. A side effect is anything a drug does besides treating cancer. Participants in this trial have HER2-positive (HER2+) breast cancer that has either spread to other parts of the body (metastatic) or cannot be removed completely with surgery (unresectable). All participants will get both tucatinib and trastuzumab deruxtecan.

  • Conditions: breast cancer
  • Phase: II
  • Trial ID: NCT04539938
  • Protocol ID: 20-515

Enrolling

Randomized, double-blind, phase 3 study of tucatinib or placebo in combination with ado-trastuzumab emtansine (T-DM1) for subjects with unresectable locally-advanced or metastatic HER2+ breast cancer

Trial Description: This study is being done to see if tucatinib with ado-trastuzumab emtansine (T-DM1) works better than T-DM1 alone to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma. The breast cancer in this study is either metastatic (spread into other parts of the body) or cannot be removed completely with surgery. Patients in this study will be randomly assigned to get either tucatinib or placebo (a pill with no medicine). This is a blinded study, so neither patients nor their doctors will know whether a patient gets tucatinib or placebo. All patients in the study will get T-DM1, a drug that is often used to treat this cancer. Each treatment cycle lasts 21 days. Patients will swallow tucatinib pills or placebo pills two times every day. Patients will get T-DM1 injections from the study site staff on the first day of every cycle.

  • Conditions: her2-positive breast cancer
  • Phase: III
  • Trial ID: NCT03975647
  • Protocol ID: 20-032

Not Enrolling

A randomized phase II trial of carboplatin with or without nivolumab in first-line metastatic triple-negative breast cancer

Trial Description: This research study is studying a drug called Carboplatin with or without another study drug, Nivolumab as a possible treatment for triple-negative breast cancer that has spread to other parts of the body. The interventions involved in this study are: - Carboplatin - Nivolumab

  • Conditions: breast cancer
  • Phase: II
  • Trial ID: NCT03414684
  • Protocol ID: 17-512

Not Enrolling

A phase 1 study of the CDK4/6 inhibitor ribociclib (LEE011) in combination with the PD-1 inhibitor PDR001 in patients with metastatic hormone receptor-positive breast cancer and metastatic ovarian cancer

Trial Description: This clinical trial is studying the drug Ribociclib (LEE011) in combination with an immunotherapy drug called PDR001 (a therapy that uses the body's own immune system to control cancer) as a possible treatment for metastatic hormone-receptor-positive (HR+), HER2-negative breast cancer (in combination with fulvestrant) or metastatic epithelial ovarian cancer. The names of the medications involved in this study are: - Ribociclib (LEE011) - PDR001 - Fulvestrant

  • Conditions: her2-negative breast cancer, metastatic epithelial ovarian cancer, metastatic hormone-receptor-positive (hr+) breast cancer
  • Phase: I
  • Trial ID: NCT03294694
  • Protocol ID: 17-285

Not Enrolling

NIMBUS: A phase II study of nivolumab plus ipilimumab in metastatic hypermutated HER2-negative breast cancer

Trial Description: This research study is studying a drug combination of nivolumab and ipilimumab as a possible treatment for hypermutated HER2 negative breast cancer. The drugs involved in this study are: - Nivolumab (Opdivo ®) - Ipilimumab (Yervoy ®)

  • Conditions: breast cancer
  • Phase: II
  • Trial ID: NCT03789110
  • Protocol ID: 18-561

Not Enrolling

An International, Multi-Center, Open-Label, Randomized, Phase III Trial of Sacituzumab Govitecan versus Treatment of Physician Choice in Patients with Metastatic Triple-Negative Breast Cancer Who Received at Least Two Prior Treatments

Trial Description: The primary objective of this study is to compare the efficacy of sacituzumab govitecan to the treatment of physician's choice (TPC) as measured by independently-reviewed Independent Review Committee (IRC) progression-free survival (PFS) in participants with locally advanced or metastatic triple-negative breast cancer (TNBC) previously treated with at least two systemic chemotherapy regimens for unresectable, locally advanced or metastatic disease, and without brain metastasis at baseline.

  • Conditions: breast cancer
  • Phase: III
  • Trial ID: NCT02574455
  • Protocol ID: 17-495

Enrolling

Saci-IO TNBC: Randomized phase II study of sacituzumab govitecan with or without pembrolizumab in PD-L1-negative metastatic triple negative breast cancer (TNBC)

Trial Description: This research study involves testing the safety and efficacy of an investigational intervention for patients with triple-negative breast cancer (TNBC) that has spread, or metastasized, to other parts the body and is PD-L1-negative. The names of the study interventions involved in this study are: - Sacituzumab govitecan (Trodelvy™;IMMU-132) - Pembrolizumab (Keytruda®; MK-3475)

  • Conditions: breast cancer, pd-l1 negative, triple negative breast cancer
  • Phase: II
  • Trial ID: NCT04468061
  • Protocol ID: 20-166