A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how well several treatment combinations work and how safe they are. It is for adults with breast cancer that has spread to other parts of the body or nearby tissue and cannot be removed with surgery. Study groups depend on cancer type, tumor test results, and past treatments.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be at least 18 years old.
- Have breast cancer that has spread to other parts of the body or nearby tissue and cannot be removed with surgery.
- Have cancer that can be measured on scans.
- Be fully active or able to do light work, and able to follow study rules.
- Be expected to live at least 3 months.
- Have a stored tumor sample for testing, or a tumor that can be sampled with a biopsy.
- Have blood and organ test results that meet study requirements within 14 days before treatment.
- Follow your treatment group's rules about birth control or avoiding sex, breastfeeding, and egg or sperm donation.
Who can't join
- For Stage 1: past use of certain immune-based cancer treatments, recent cancer treatment, recent or planned medicines that weaken the immune system, or qualifying only for the comparison group.
- Ongoing side effects from past cancer treatment that are more than mild, except hair loss or some nerve damage; or an experimental treatment within 28 days.
- Uncontrolled cancer pain, or fluid around the lungs, heart, or belly that needs draining at least monthly.
- Cancer in the brain or spinal cord that causes symptoms, is untreated, or is worsening; or a history of cancer in their lining.
- A current or past illness where the immune system attacks the body, a weak immune system, or certain types of lung scarring or inflammation.
- Active tuberculosis, a severe infection within 4 weeks, or antibiotics taken by mouth or vein to treat an infection within 2 weeks.
- Significant heart or blood vessel disease, a past donor stem cell or organ transplant, or another cancer within 2 years, with some low-risk exceptions.
- Being pregnant, breastfeeding, or planning to become pregnant during the study.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria Patients must meet all of the following criteria to qualify for Stage 1 (all cohorts) and to qualify for Stage 2 (2L CIT-naïve cohort): * Age \>/= 18 years at the time of signing Informed Consent Form * Eastern cooperative oncology group (ECOG) performance status of 0 or 1 * Able to comply with the study protocol, in the investigator's judgment * Metastatic or inoperable locally advanced adenocarcinoma of the breast * Measurable disease (at least one target lesion) according to RECIST v1.1 * Life expectancy \>/= 3 months, as determined by the investigator * Tumor accessible for biopsy, unless archival tissue is available * Availability of a representative tumor specimen that is suitable for biomarker analysis via central testing * Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from breastfeeding and donating eggs, as outlined for each specific treatment arm * For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as outlined for each specific treatment arm Exclusion Criteria Exclusion Criteria for Stage 1 * Prior treatment with T-cell co-stimulating or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, CD40 agonists or interleukin-2 (IL-2) or IL-2-like compounds * Biologic treatment (e.g., bevacizumab) within 2 weeks prior to initiation of study treatment, or other systemic treatment for TNBC within 2 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment * Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor alpha agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during the course of the study * Eligibility only for the control arm Exclusion Criteria for Stage 1 (both cohorts) and Stage 2 (2L CIT-naïve cohort) * Adverse events from prior anti-cancer therapy that have not resolved to Grade \</= 1 or better with the exception of alopecia of any grade and Grade \</= 2 peripheral neuropathy * Treatment with investigational therapy within 28 days prior to initiation of study treatment * Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) * Uncontrolled tumor-related pain * Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases * History of leptomeningeal disease * Active or history of autoimmune disease or immune deficiency * History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. * Active tuberculosis * Severe infection within 4 weeks prior to initiation of study treatment * Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment * Significant cardiovascular disease * Prior allogeneic stem cell or solid organ transplantation * History of malignancy other than breast cancer within 2 years prior to screening, with the exception of those with a negligible risk of metastasis or death * Pregnancy or breastfeeding, or intention of becoming pregnant during the study
Study sites (26)
CA
- City of Hope - Duarte · Duarte, CA 91010More trials in Duarte
- City of Hope · Duarte, CA 91010More trials in Duarte
- City of Hope - Orange County Lennar Foundation Cancer Center · Irvine, CA 92618More trials in Irvine
- University of California San Diego (UCSD) - Koman Family Outpatient Pavilion ? La Jolla · La Jolla, CA 92093-1350More trials in La Jolla
- University of California San Diego Medical Center · La Jolla, CA 92093More trials in La Jolla
- UCLA Health 200 Medical Plaza · Los Angeles, CA 90004More trials in Los Angeles
- Stanford Cancer Institute · Stanford, CA 94305More trials in Stanford
CO
- Rocky Mountain Cancer Center - Longmont · Longmont, CO 80501More trials in Longmont
FL
- H. Lee Moffitt Cancer Center and Research Inst. · Tampa, FL 33612More trials in Tampa
IL
- City of Hope® Cancer Center Chicago · Zion, IL 60099More trials in Zion
MN
- Metro-Minnesota Community Oncology Research Consortium · Saint Paul, MN 55101-2502More trials in Saint Paul
NC
- Duke Cancer Institute · Durham, NC 27710-2000More trials in Durham
NE
- Nebraska Cancer Specialists - Midwest Cancer Center - Legacy · Omaha, NE 68130More trials in Omaha
NJ
- Hackensack Univ Medical Center · Hackensack, NJ 07601More trials in Hackensack
- Regional Cancer Care Associates, LLC · Howell Township, NJ 07731More trials in Howell Township
- Rutgers Cancer Institute of New Jersey · New Brunswick, NJ 08901More trials in New Brunswick
NV
- Renown Regional Medical Center · Reno, NV 89502-1576More trials in Reno
NY
- NYU Langone Medical Center · New York, NY 10016More trials in New York
OH
- The Ohio State University Comprehensive Cancer Center · Columbus, OH 43212-3117More trials in Columbus
PA
- Thomas Jefferson University Hospital · Philadelphia, PA 19107More trials in Philadelphia
- University of Pittsburgh Medical Center · Pittsburgh, PA 15213More trials in Pittsburgh
TN
- Tennessee Oncology - Chattanooga Oncology & Hematology Associates · Chattanooga, TN 37404More trials in Chattanooga
- The West Clinic · Germantown, TN 38138More trials in Germantown
- Tennessee Oncology PLLC · Nashville, TN 37203More trials in Nashville
- Vanderbilt University Medical Center · Nashville, TN 37212More trials in Nashville
TX
- Texas Oncology-Plano East · Plano, TX 75075-7787More trials in Plano