A Study to Evaluate the Efficacy and Safety of Multiple Treatment Combinations in Patients with Breast Cancer (Morpheus- Breast Cancer)

Phase 1

• Conditions: Breast cancer; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-507495-48-00
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-26
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 210

Inclusion Criteria

Cohort-1: Documented estrogen receptor+ tumor according to American Society of Clinical Oncology/College of American Pathologists guidelines, assessed locally and defined as >= 1% of tumor cells stained positive based on the most recent tumor biopsy or archived tumor sample, Cohort-1: 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, Cohort-1: Radiologic/objective evidence of recurrence or progression after the most recent systemic therapy for breast cancer, Cohort-2: Documented ER + tumor according to ASCO/CAP guidelines, assessed locally and defined as >= 1% of tumor cells stained positive based on the most recent tumor biopsy. Patient must be considered appropriate for ET and anti-HER2 therapy, Cohort-1 and Cohort 2: Measurable disease according to RECIST v1.1, Cohort-2:HER2-positive as defined by ASCO/CAP guidelines

Exclusion Criteria

Cohort-1: Known HER2-positive breast cancer, Cohort-1: Prior treatment with cytotoxic chemotherapy for metastatic breast cancer (except for single agent capecitabine, which will count as a line of therapy), Cohort-1: Prior treatment with SERD (except fulvestrant), Cohort-2: Prior treatment with any of the protocol specified study treatments, Cohort-2: Systemic treatment for breast cancer within 2 weeks of Day 1 of Cycle 1 or 5 half-lives of the drug (whichever is longer) prior to Day 1 of Cycle 1, Cohort-2: Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified