Spots Global Cancer Trial Database for A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
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Trial Identification
Brief Title: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
Official Title: 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)
Study ID: NCT04802759
Study Description
Brief Summary: This is a Phase Ib/II, open-label, multicenter, randomized umbrella study in participants with breast cancer. Cohort 1 will focus on participants with inoperable, locally advanced or metastatic, estrogen receptor (ER)-positive, 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-positive, 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). 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. During Stage 1, participants in each cohort will be randomly assigned to treatment arms. Participants in the control or experimental arms who experience unacceptable toxicity, disease progression as determined by the investigator according to RECIST v1.1, or loss of clinical benefit as determined by the investigator during Stage 1 will be given the option of receiving a different treatment combination during Stage 2, provided they meet eligibility criteria and a treatment arm is open for enrollment. No Stage 2 treatment is currently available.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
City of Hope, Duarte, California, United States
University of California, San Francisco (UCSF), San Francisco, California, United States
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Santa Monica, California, United States
Stanford Cancer Institute (SCI), Stanford, California, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Regional Cancer Care Associates LLC (RCCA) - Freehold Location, Freehold, New Jersey, United States
Regional Cancer Care Associates LLC ? Howell Division, Howell, New Jersey, United States
Levine Cancer Institute, Charlotte, North Carolina, United States
Thomas Jefferson University Hospital;Medical Oncology, Philadelphia, Pennsylvania, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
West Cancer Center, Germantown, Tennessee, United States
Flinders Medical Centre, Bedford Park, South Australia, Australia
Peninsula Health-Frankston Hospital, Frankston, Victoria, Australia
Peter Maccallum Cancer Centre, Melbourne, Victoria, Australia
Linear Clinical Research Limited, Nedlands, Western Australia, Australia
Hadassah Ein Karem Hospital, Jerusalem, , Israel
Rabin MC; Davidof Center - Oncology Institute, Petach Tikva, , Israel
The Chaim Sheba Medical Center, Ramat Gan, , Israel
Tel Aviv Sourasky Medical Center; Movement Disorder, Tel Aviv, , Israel
National Cancer Center, Goyang-si, , Korea, Republic of
Seoul National University Hospital, Seoul, , Korea, Republic of
Severance Hospital, Seoul, , Korea, Republic of
Asan Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Hospital Universitario Vall d Hebron, Barcelona, , Spain
Hospital Universitario Ramón y Cajal, Madrid, , Spain
Centro Integral Oncológico Clara Campal Ensayos Clínicos START, Madrid, , Spain
Hospital Clinico Universitario de Valencia; Servicio de Anatomia Patologica, Valencia, , Spain
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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