A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer (NCT04802759)
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Breast Cancer (MORPHEUS-BREAST CANCER)
🩺 Plain-English Summary (8th-Grade Level)
This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with breast cancer. The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, or modify the patient population. Cohort 1 will focus on participants with inoperable, locally advanced or metastatic, estrogen receptor-positive (ER+), HER2-negative breast cancer who had disease progression during or following treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i; e.g., palbociclib, ribociclib, abemaciclib) in the first- or second-line setting. Cohort 2 will focus on inoperable, locally advanced or metastatic, ER+, HER2-positive breast cancer with previous progression to standard-of-care anti-HER2 therapies, of which one was a trastuzumab-and-taxane-based systemic therapy (including in the early setting if recurrence occurred within 6 months of finishing adjuvant therapy) and one was a HER2-targeting antibody-drug conjugate (ADC; e.g., ado-trastuzumab emtansine or trastuzumab-deruxtecan) or a HER2-targeting tyrosine kinase inhibitor (TKI; e.g., tucatinib, lapatinib, pyrotinib, or neratinib). Cohort 3 will focus on inoperable, locally advanced or metastatic, ER+, HER2-negative, PIK3CA-mutated breast cancer with resistance to adjuvant endocrine therapy.
Who can join: Review the eligibility criteria below.
Location: City of Hope — Duarte, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "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 (32 Sites)
Showing the first 25 of 32 sites.
- City of Hope — Duarte, California
- City of Hope - Orange County Lennar Foundation Cancer Center — Irvine, California
- University of California, San Francisco (UCSF) — San Francisco, California
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Santa Monica, California
- Stanford Cancer Institute (SCI) — Stanford, California
- Massachusetts General Hospital — Boston, Massachusetts
- Regional Cancer Care Associates LLC (RCCA) - Freehold Location — Freehold, New Jersey
- Regional Cancer Care Associates LLC ? Howell Division — Howell Township, New Jersey
- Levine Cancer Institute — Charlotte, North Carolina
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania
- University of Pittsburgh Cancer Institute — Pittsburgh, Pennsylvania
- West Cancer Center — Germantown, Tennessee
- Flinders Medical Centre — Bedford Park, South Australia
- Peninsula Health-Frankston Hospital — Frankston, Victoria
- Peter Maccallum Cancer Centre — Melbourne, Victoria
- Linear Clinical Research Limited — Nedlands, Western Australia
- Shaare Zedek Medical Center — Jerusalem, Jerusalem
- Rambam Medical Center — Haifa,
- Hadassah Ein Karem Hospital — Jerusalem,
- Rabin MC — Petah Tikva,
- The Chaim Sheba Medical Center — Ramat Gan,
- Tel Aviv Sourasky Medical Center — Tel Aviv,
- Assuta Medical Centers — Tel Aviv,
- National Cancer Center — Goyang-si,
- Samsung Medical Center — Seoul,
📞 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.
Explore by condition: All Inoperable, Locally Advanced or Metastatic, ER-positive 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.