A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer
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)
Sponsor: Hoffmann-La Roche
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Percentage of Participants with Objective Response, Defined as a Complete or Partial Response, as Determined by the Investigator According to Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1)
Time frame: From Baseline until disease progression (up to 6 years)
Number of Participants with Adverse Events, Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE v5.0)
Time frame: From Baseline until 30 days after the last dose of study drug (up to 6 years)
Secondary Endpoints
Progression-Free Survival, as Determined by the Investigator According to RECIST v1.1
Disease Control Rate, Defined as the Percentage of Participants with Stable Disease for ≥12 Weeks or a Complete or Partial Response, as Determined by the Investigator According to RECIST v1.1
Clinical Benefit Rate, Defined as the Percentage of Participants with Stable Disease for ≥24 Weeks or with Confirmed Complete or Partial Response, as Determined by the Investigator According to RECIST v1.1
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria for Cohort 1 (Stage 1 \[and Stage 2, only where indicated\]): * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 * Documented estrogen receptor-positive (ER+) tumor * Patients for whom endocrine therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines * Radiologic/objective evidence of recurrence or progression after the most recent systemic therapy for breast cancer * Disease progression during or after first- or second-line hormonal therapy for locally advanced or metastatic disease (note: at least one line of therapy must have contained a CDK4/6i administered for a minimum of 8 weeks prior to disease progression.) * Postmenopausal status for women * Life expectancy ≥3 months * Availability of a representative tumor specimen that is suitable for biomarker evaluation via central testing * Prior fulvestrant therapy is all…
Read full criteria on CT.gov →✦ Analyst Commentary
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