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48 Clinical Trials Found

Enrolling

A Phase II Study of Neratinib Alone and in Combination with Fulvestrant in Metastatic HER2 Non-amplified but HER2 Mutant Breast Cancer

This phase II trial studies how well neratinib with or without fulvestrant works in treating patients with human epidermal growth factor receptor 2 (HER2)-negative breast cancer that carries HER2 gene mutations and has spread to other parts of the body (metastatic). Neratinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Estrogen can stimulate the...

  • Phase: II
  • Trial ID: NCT01670877

Not Enrolling

Palbociclib in Combination with Fulvestrant or Tamoxifen as Treatment for Hormone Receptor Positive Metastatic Breast Cancer with Prior Chemotherapy for Advanced Disease: A Phase II study with Pharmacodynamics Markers

This phase II trial studies the side effects of palbociclib when given together with fulvestrant or tamoxifen citrate in treating patients with hormone receptor positive breast cancer that has spread from where it started to nearby tissue or lymph nodes (locally advanced) or has spread to other places in the body (metastatic). Palbociclib may stop the growth of tumor cells by blocking some of the...

  • Phase: II
  • Trial ID: NCT02384239

Not Enrolling

Phase 2 Randomized, Double-Blinded, Controlled Study of Tucatinib vs. Placebo in Combination with Capecitabine and Trastuzumab in Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma (HER2CLIMB)

This study is being done to see if tucatinib works better than placebo 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. All patients in the study will get capecitabine and trastuzumab, two drugs that are often used...

  • Phase: II
  • Trial ID: NCT02614794

Enrolling

A Phase 1b Study of Abemaciclib in Combination with Pembrolizumab for Patients with Stage IV Non-Small Cell Lung Cancer or Hormone Receptor Positive, HER2 Negative Breast Cancer

The main purpose of this study is to evaluate the safety and efficacy of abemaciclib in combination with pembrolizumab in participants with advanced non-small cell lung cancer (NSCLC) or hormone receptor positive (HR+), human epidermal growth factor receptor negative (HER2-) breast cancer.

  • Phase: II
  • Trial ID: NCT02779751

Not Enrolling

A Phase 2 Open Label, Multi-Center, Multinational, Randomized, Parallel Design Study Investigating The Efficacy and Safety Of GTx-024 On Metastatic or Locally Advanced ER+/AR+ Breast Cancer (BC) in Postmenopausal Women

The purpose of this study is to determine if GTx-024 at different dosages (9 mg or 18 mg) is effective and safe in the treatment of patients with metastatic or locally advanced ER+ and AR+ breast cancer in postmenopausal women.

  • Phase: II
  • Trial ID: NCT02463032

Not Enrolling

An open-label, phase Ib/II clinical trial of CDK 4/6 inhibitor, ribociclib (LEE011), in combination with trastuzumab or TDM-1 for advanced/metastatic HER2-positive breast cancer.

This phase Ib / II trial studies the best dose of ribociclib with trastuzumab or trastuzumab emtansine and to see how well they work in treating patients with breast cancer that has spread from where it started to nearby tissue or lymph nodes or other places in the body and is human epidermal growth factor receptor 2 (HER2)-positive. Ribociclib may stop the growth of tumor cells by blocking some...

  • Phase: I/II
  • Trial ID: NCT02657343

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.

This phase Ib / IIa trial studies the side effects and best dose of palbociclib and everolimus and how well they work when given together with exemestane in treating patients with estrogen receptor positive and human epidermal growth factor receptor 2 (HER2) negative breast cancer that has spread to other places in the body. Palbociclib, everolimus, and exemestane may stop the growth of tumor...

  • Phase: I/II
  • Trial ID: NCT02871791

Enrolling

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

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) for breast cancer that has spread to other parts of the body.

  • Phase: I
  • Trial ID: NCT02057133

Enrolling

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

This study will examine the safety and tolerability of SGN-LIV1A (ladiratuzumab vedotin) in patients with metastatic breast cancer. SGN-LIV1A will be given every 3 weeks alone or in combination with trastuzumab.

  • Phase: I
  • Trial ID: NCT01969643

Enrolling

A Phase 1 Study of PARP inhibitor olaparib and HSP90 inhibitor AT13387 for treatment of advanced solid tumors with expansion in patients with recurrent epithelial ovarian, fallopian tube, peritoneal cancer or recurrent triple-negative breast cancer

This phase I trial studies the side effects and best dose of olaparib and onalespib when given together in treating patients with solid tumors that have spread to other places in the body or cannot be removed by surgery or ovarian, fallopian tube, primary peritoneal, or triple-negative breast cancer that has come back. Olaparib and onalespib may stop the growth of tumor cells by blocking some of...

  • Phase: I
  • Trial ID: NCT02898207

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

This phase II trial studies the side effects and how well palbociclib and letrozole or fulvestrant works in treating patients 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,...

  • Phase: II
  • Trial ID: NCT03633331

Enrolling

A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS- 8201A, an Anti-HER2-Antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated with Prior Standard of Care HER2 Therapies, Including T-DM1

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

  • Phase: III
  • Trial ID: NCT03523585

Enrolling

Phase II Trial of GDC-0084 in combination with Trastuzumab for Patients with HER2-Positive Breast Cancer Brain Metastases

This phase II trial studies how well PI3K inhibitor GDC-0084 (GDC-0084) in combination with trastuzumab works in treating patients with HER2 positive breast cancer that has spread to the brain. GDC-0084 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Trastuzumab is a form of “targeted therapy” because it works by attaching itself to specific molecules...

  • Phase: II
  • Trial ID: NCT03765983

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

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...

  • Phase: III
  • Trial ID: NCT03326674

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

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.

  • Phase: III
  • Trial ID: NCT02947685

Enrolling

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

This phase II trial studies how well nivolumab and ipilimumab work in treating patients with hypermutated HER2-negative breast cancer that has spread to other parts of the body. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

  • Phase: II
  • Trial ID: NCT03789110

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

This randomized pilot phase II trial studies how well fulvestrant with or without palbociclib and avelumab works in treating patients with hormone receptor positive, HER2 negative breast cancer that has spread to other parts of the body or that has come back after a period of improvement and cannot be removed by surgery, and have been previously treated with CDK and endocrine therapy. Endocrine...

  • Phase: II
  • Trial ID: NCT03147287

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

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

  • Phase: III
  • Trial ID: NCT03734029

Enrolling

ELACESTRANT MONOTHERAPY VS. STANDARD OF CARE FOR THE TREATMENT OF PATIENTS WITH ER+/HER2- ADVANCED BREAST CANCER FOLLOWING CDK4/6 INHIBITOR THERAPY: A PHASE 3 RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER TRIAL (EMERALD)

This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at least one endocrine therapy including a CDK4 / 6 inhibitor in combination with fulvestrant or an aromatase inhibitor (AI) .

  • Phase: III
  • Trial ID: NCT03778931

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

This phase I trial studies the side effects and best dose of ribociclib when given together with spartalizumab with or without fulvestrant in treating patients with hormone receptor positive and HER2 negative breast cancer that has spread to other places in the body (metastatic), or ovarian, fallopian tube, or primary peritoneal cancer that has spread to other places in the body (metastatic)....

  • Phase: I
  • Trial ID: NCT03294694

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

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.

  • Phase: II
  • Trial ID: NCT02939274

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

CONTESSA TRIO is a 2-cohort, multicenter, Phase 2 study of tesetaxel, an investigational, orally administered taxane. In Cohort 1, approximately 90 patients (with potential expansion to up to 150 patients) with locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior chemotherapy for advanced disease will be randomized 1:1:1 to receive tesetaxel plus either:...

  • Phase: II
  • Trial ID: NCT03952325

Not Enrolling

A Phase II study of cisplatin + AZD-1775 in metastatic triple-negative breast cancer and evaluation of pCDC2 as a biomarker of response

This phase II trial studies how well cisplatin and adavosertib work in treating patients with triple-negative breast cancer that has spread to nearby tissue, lymph nodes, or other places in the body. Drugs used in the chemotherapy, such as cisplatin, 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...

  • Phase: II
  • Trial ID: NCT03012477

Enrolling

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

This phase Ib trial studies the side effects and best way to give pembrolizumab and trastuzumab emtansine in treating patients with HER2-positive breast cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as pembrolizumab and trastuzumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and...

  • Phase: I
  • Trial ID: NCT03032107

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

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...

  • Phase: III
  • Trial ID: NCT02915744

Not Enrolling

A phase II study of pembrolizumab in combination with palliative radiotherapy for metastatic hormone receptor positive breast cancer

This phase II trial studies how well pembrolizumab and palliative radiation therapy work in treating patients with invasive breast cancer that has spread to other places in the body. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation therapy uses high...

  • Phase: II
  • Trial ID: NCT03051672

Not Enrolling

PHASE 1, TWO-PART, MULTICENTER, NON-RANDOMIZED, OPEN-LABEL, MULTIPLE DOSE FIRST-IN-HUMAN STUDY OF DS-8201A, IN SUBJECTS WITH ADVANCED SOLID MALIGNANT TUMORS

This is an open-label, two-part, multiple study to evaluate the safety and tolerability of DS-8201a in patients with advanced solid malignant tumors.

  • Phase: I
  • Trial ID: NCT02564900

Enrolling

A Phase 2 Study to Evaluate Safety and Anti-Tumor Activity of Avelumab in Combination with Talazoparib in Patients with BRCA or ATM Mutant Tumors

Avelumab in combination with talazoparib will be investigated in patients with locally advanced or metastatic solid tumors with a BRCA or ATM defect.

  • Phase: II
  • Trial ID: NCT03565991

Enrolling

Randomized Phase II Trial to Evaluate Alisertib Alone or Combined with Fulvestrant for Women with Advanced, Endocrine-resistant Breast Cancer

This phase II trial studies how well alisertib with or without fulvestrant works in treating patients with endocrine-resistant breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or that has spread to other places in the body (metastatic). Alisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hormone therapy using...

  • Phase: II
  • Trial ID: NCT02860000