Breast Cancer Clinical Trials

California Pacific CURRENTS: The online journal of CPMC Research Institute

Adjuvant Treatment of Early Stage Breast Cancer

Title: Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women With Early Breast Cancer

Description: This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence).
 

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

FEMALE subjects, 18 y/o and older, with a histologically confirmed invasive breast cancer and registration must occur within 12 months after the first histologic diagnosis of invasive breast cancer

Status

Please contact site for study status

Contacts

Andrea Davila, 415-600-1544

Title: A Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK-3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer With ≥ 1 cm Residual Invasive Cancer or Positive Lymph Nodes (ypN+) After Neoadjuvant Chemotherapy

Description: This randomized phase III trial studies how well pembrolizumab works in treating triple-negative breast cancer

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

MALE and FEMALE subjects, 18 y/o and older, with a histologically confirmed estrogen receptor (ER)-, progesterone receptor (PR)- and HER2-negative (triple-negative, TNBC) with residual invasive breast cancer, as defined by the 2010 and 2013 American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines, after completion of neoadjuvant chemotherapy

Status

Please contact site for study status

Contacts

Andrea Davila, 415-600-1544

A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy vs. Observation in Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy

Description: This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to observation in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant)

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

MALE and FEMALE subjects, 18 y/o and older, with histologically confirmed triple negative (estrogen receptor negative [ER-]/progesterone receptor negative [PR-]/human epidermal growth factor receptor-2 negative [HER2-]) invasive breast cancer, clinical stage II-III at diagnosis

Status

Please contact site for study status

Contacts

Madeline Decker, 415-600-3613

 

A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer

Description: This randomized phase III trial studies how well doxorubicin hydrochloride and cyclophosphamide followed by paclitaxel with or without carboplatin work in treating patients with triple-negative breast cancer. Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, paclitaxel, and carboplatin, 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. It is not yet known whether doxorubicin hydrochloride and cyclophosphamide is more effective when followed by paclitaxel alone or paclitaxel and carboplatin in treating triple-negative breast cancer.

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

MALE and FEMALE subjects, 18 y/o and older, with unilateral invasive adenocarcinoma of the breast on histologic examination

Status

Please contact site for study status

Contacts

Madeline Decker, 415-600-3613

 

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients With High-Risk, Hormone Receptor-Positive and HER2/Neu Negative Breast Cancer

Description: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

MALE and FEMALE subjects, 18 y/o and older, who have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen (ER)- and/or progesterone-receptor (PR) status, and negative human epidermal growth factor receptor (HER)2, for whom standard adjuvant endocrine therapy is planned

Status

Please contact site for study status

Contacts

Madeline Decker, 415-600-3613

 

A Randomized, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy

Description: Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

MALE and FEMALE subjects, 18 years and older, who have a histologically confirmed non-metastatic primary triple negative invasive adenocarcinoma of the breast.

Status

Please contact site for study status

Contacts

Madeline Decker, 415-600-361

 

A Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1-3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy

Description: This randomized phase III trial studies axillary lymph node dissection to see how well it works compared to axillary radiation therapy in treating patients with node-positive breast cancer treated with neoadjuvant chemotherapy followed by surgery

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

MALE and FEMALE subjects, 18 y/o and older, with a clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy) by American Joint Committee on Cancer (AJCC) staging 7th edition

Status

Please contact site for study status

Contacts

Madeline Decker, 415-600-3613

 

Randomized Double-Blind Placebo Controlled Study of Subcutaneous Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias

Description: Testosterone in Treating Postmenopausal Patients With Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

FEMALE subjects, 18 y/o and older, who have undergone a total mastectomy or breast-conserving surgery for primary breast cancer +/-chemotherapy and +/-radiotherapy

Status

Please contact site for study status

Contacts

Madeline Decker, 415-600-3613

 

Alternate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer Neoadjuvant Treatment (ALTERNATE) in Postmenopausal Women: A Phase III Study

Description: Fulvestrant and/or Anastrozole in Treating Postmenopausal Patients With Stage II-III Breast Cancer Undergoing Surgery

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

FEMALE subjects, 18 y/o and older, with a diagnosis of breast cancer

Status

Please contact site for study status

Contacts

Madeline Decker, 415-600-3613

 

 

Advanced or Metastatic Breast Cancer

A Randomized Open-Label Phase III Study of Single Agent Pembrolizumab Versus Single Agent Chemotherapy Per Physician's Choice for Metastatic Triple Negative Breast Cancer (mTNBC) - (KEYNOTE-119)

Description: In this study, participants with metastatic triple negative breast cancer (mTNBC) will be randomly assigned to receive either single agent pembrolizumab or single agent chemotherapy chosen by the treating physician (TPC) in accordance with local regulations and guidelines, consisting of either capecitabine, eribulin, gemcitabine, or vinorelbine.
 

Investigators

Eligibility Requirements

MALE and FEMALE subjects, 18 y/o and older, with a centrally confirmed metastatic triple negative breast cancer (mTNBC)

Status

Active and open to enrollment

Contacts

Madeline Decker, 415-600-3613, Email: DeckerM@cpmcri.org about Study KEYNOTE-119

Phase II Randomized Placebo-Controlled Trial of Cisplatin With or Without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer

Description:This randomized phase II trial studies how well cisplatin works with or without veliparib in treating patients with stage IV triple-negative breast cancer and/or breast cancer (BRCA) mutation-associated breast cancer.

 

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

MALE and FEMALE subjects, 18 y/o and older, with metastatic breast cancer (MBC) stage IV disease

Status

Please contact site for study status

Contacts

Madeline Decker, 415-600-3613

A Randomized Phase II Trial of Tamoxifen Versus Z-Endoxifen HCL in Postmenopausal Women with Metastatic Estrogen Receptor Positive, HER2 Negative Breast Cancer

Description: This randomized phase II trial studies how well tamoxifen citrate works compared with z-endoxifen hydrochloride in treating patients with breast cancer that has spread to nearby tissue or lymph nodes or other parts of the body and has estrogen receptors but not human epidermal growth factor receptor 2 (HER2) receptors on the surface of its cells. Estrogen can cause the growth of tumor cells. Hormone therapy using tamoxifen citrate or z-endoxifen hydrochloride may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known whether tamoxifen citrate or z-endoxifen hydrochloride is more effective in treating patients with breast cancer.

Investigators

  • NCI - National Cancer Institute

Eligibility Requirements

FEMALE subjects, 18 y/o and older, who agree to undergo a standard of care core biopsy of recurrent or metastatic breast cancer to confirm that is ER+ (>= 10% nuclear staining) and HER2 negative, have been previously treated with an aromatase inhibitor (either letrozole, anastrozole or exemestane) either in the adjuvant or metastatic setting, and have primary or secondary endocrine resistant disease.

Status

Please contact site for study status

Contacts

Madeline Decker, 415-600-3613

 

A Randomized, Open-label, Multicenter, Phase 1b/2 Study of Eribulin Mesylate in Combination With PEGylated Recombinant Human Hyaluronidase (PEGPH20) Versus Eribulin Mesylate Alone in Subjects With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative, High-Hyaluronan (HA) Metastatic Breast Cancer (MBC)

Description: The primary objective for the study is as follows: For the Phase 1b - to determine safety tolerability and recommended Phase 2 dose (RP2D) of eribulin mesylate in combination with PEGylated recombinant human hyaluronidase (PEGPH20) in participants with Human Epidermal Growth Factor Receptor (HER2)-negative metastatic breast cancer (MBC) previously treated with 0 to 1 line of systemic anticancer therapy in the metastatic setting. For the Phase 2 - to evaluate objective response rate (ORR) of eribulin mesylate in combination with PEGPH20 in participants with HER2-negative, High-Hyaluronan (HA)-high, MBC previously treated with 0 to 1 line of systemic anticancer therapy in the metastatic setting.

 

Investigator

Eligibility Requirements

MALE and FEMALE Subjects, 18 y/o and older, with histological adenocarcinoma of the breast

Status

Coming soon.

Contacts

Madeline Decker, 415-600-3613

 

A Phase III Randomized Double-blind, Placebo Controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment

Description: The purpose of this study is to determine whether treatment with alpelisib plus fulvestrant prolongs progression-free survival compared to fulvestrant and placebo in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer, who received prior treatment with an Aromatase Inhibitor either as (neo)adjuvant or for advanced disease.
 

Investigator

Eligibility Requirements

MALE and FEMALE subjects, 18 y/o and older, with a recurrence or progression of disease during or after AI therapy.

Status

Open to enrollment.

Contacts

Madeline Decker, 415-600-3613

 

A Randomized, Multicenter, Double Blind, Placebo-Controlled Phase II Study Of The Efficacy And Safety Of Trastuzumab Emtansine In Combination With Atezolizumab Placebo In Patients With Her2-Positive Locally Advanced Or Metastatic Breast Cancer Who Have Received Prior Trastuzumab And Taxane Based Therapy

Description: This study is to evaluate the efficacy of the combination of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo
 

Investigator

Eligibility Requirements

Clinical Trial Eligibility Requirements

Status

Active and open to enrollment

Contacts

Madeline Decker, 415-600-3613

 

Title: A Randomized, Double-Blind, Phase III Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy for Previously Untreated Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer - (KEYNOTE-355)

Description: The primary hypotheses are that the combination of pembrolizumab and chemotherapy prolongs Progression-Free Survival (PFS) compared to placebo and chemotherapy in all participants and in participants with programmed cell death ligand 1 (PD-L1) positive tumors, and prolongs Overall Survival (OS) compared to placebo and chemotherapy in all participants and in participants with PD-L1 positive tumors.

Investigator

Eligibility Requirements

MALE and FEMALE subjects, 18 y/o and older, who have locally recurrent inoperable breast cancer not previously treated with chemotherapy and which cannot be treated with curative intent OR has metastatic breast cancer not previously treated with chemotherapy.

Status

Coming soon.

Contacts

Madeline Decker, 415-600-3613