A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (NCT03424005)
A Phase Ib/II, Open-label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic Breast Cancer (Morpheus-panBC)
🩺 Plain-English Summary (8th-Grade Level)
This is an umbrella study evaluating the efficacy and safety of multiple treatment combinations in participants with metastatic or inoperable locally advanced breast cancer. The study will be performed in two stages. During Stage 1, seven cohorts will be enrolled in parallel in this study: Cohort 1 will consist of programmed death-ligand 1 (PD-L1)-positive participants who have received no prior systemic therapy for metastatic or inoperable locally advanced triple-negative breast cancer (TNBC) (first-line \[1L\] PD-L1+ cohort). Cohort 2 will consist of participants who had disease progression during or following 1L treatment with chemotherapy for metastatic or inoperable locally-advanced TNBC and have not received cancer immunotherapy (CIT) (second-line \[2L\] CIT-naïve cohort). Cohort 3, 5, 6 and 7 will consist of participants with locally advanced or metastatic hormone receptor-positive (HR+), human epidermal growth factor receptor 2 (HER2)-negative disease with one or more PIK3CA mutations. Cohort 4 will consist of participants with locally advanced or metastatic HER2+ /HER2-low disease with one or more PIK3CA mutations who had disease progression on standard-of-care therapies (HER2+ /HER2-low cohort). In each cohort, eligible participants will initially be assigned to one of several treatment arms (Stage 1). During Stage 2, participants in the 2L CIT-naïve cohort who experience disease progression, loss of clinical benefit, or unacceptable toxicity during Stage 1 may be eligible to continue treatment with a different treatment combination, provided Stage 2 is open for enrollment and all eligibility criteria are met.
Who can join: Review the eligibility criteria below.
Location: City of Hope — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
- Capecitabine (DRUG)
- Atezolizumab (DRUG)
- Ipatasertib (DRUG)
- SGN-LIV1A (DRUG)
- Bevacizumab (DRUG)
- Chemotherapy (Gemcitabine + Carboplatin or Eribulin) (DRUG)
- Selicrelumab (DRUG)
- Tocilizumab (DRUG)
- Nab-Paclitaxel (DRUG)
- Sacituzumab Govitecan (DRUG)
- Abemaciclib (DRUG)
- Fulvestrant (DRUG)
- Ribociclib (Dose #1) (DRUG)
- Inavolisib (Dose #1) (DRUG)
- Trastuzumab Deruxtecan (DRUG)
- Ribociclib (Dose #2) (DRUG)
- Letrozole (DRUG)
- Inavolisib (Dose #2) (DRUG)
- Empagliflozin (DRUG)
- Palbociclib (DRUG)
- Metformin (DRUG)
- Atirmociclib (DRUG)
- Giredestrant (DRUG)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (49 Sites)
Showing the first 25 of 49 sites.
- City of Hope — Duarte, California
- University of California San Diego (UCSD) - Koman Family Outpatient Pavilion ? La Jolla — La Jolla, California
- University of California San Diego Medical Center — La Jolla, California
- Stanford Cancer Institute — Stanford, California
- Rocky Mountain Cancer Center - Longmont — Longmont, Colorado
- H. Lee Moffitt Cancer Center and Research Inst. — Tampa, Florida
- Metro-Minnesota Community Oncology Research Consortium — Saint Paul, Minnesota
- Renown Regional Medical Center — Reno, Nevada
- Hackensack Univ Medical Center — Hackensack, New Jersey
- Regional Cancer Care Associates, LLC — Howell Township, New Jersey
- Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey
- NYU Langone Medical Center — New York, New York
- Duke Cancer Institute — Durham, North Carolina
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania
- University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania
- Tennessee Oncology - Chattanooga Oncology & Hematology Associates — Chattanooga, Tennessee
- The West Clinic — Germantown, Tennessee
- Tennessee Oncology PLLC — Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee
- Texas Oncology-Plano East — Plano, Texas
- Peter MacCallum Cancer Centre-East Melbourne — Melbourne, Victoria
- Fiona Stanley Hospital - Medical Oncology — Murdoch, Western Australia
- Centre Léon Bérard — Lyon,
- Institut régional du Cancer Montpellier — Montpellier,
- Institut Universitaire du Cancer de Toulouse-Oncopole — Toulouse,
📞 Contact the Study Coordinator
Phone: (888) 662-6728
Email: global-roche-genentech-trials@gene.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Metastatic Breast Cancer
- Assessing the Time Demands of Cancer — Birmingham, Alabama
- Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer — Birmingham, Alabama
- A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer — Commack, New York
- Palbociclib With Fulvestrant for Metastatic Breast Cancer After Treatment With Palbociclib and an Aromatase Inhibitor — Washington D.C., District of Columbia
- A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer — Tucson, Arizona
- Roll-over Study to Allow Continued Access to Ribociclib — Chandler, Arizona
Explore by condition: All Metastatic Breast Cancer clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.