A Study to Evaluate Efficacy and Safety of Multiple Treatment Combinations in Patients with Metastatic Breast Cancer (MORPHEUS-panBC)

Phase 1

Recruiting

• Conditions: Metastatic breast cancer, including triple negative breast cancer (TNBC), hormone receptor positive breast cancer (HR+ BC), and HER2 positive and HER2 low breast cancer (HER2+/HER2-low BC); MedDRA version: 20.0Level: LLTClassification code: 10027475Term: Metastatic breast cancer Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-503629-20-00
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-02
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

Age >/= 18 years at the time of signing Informed Consent Form, ECOG Performance Status of 0 or 1, Metastatic or inoperable locally advanced breast cancer, Measurable disease (at least one target lesion) according to RECIST v1.1, Life expectancy >/= 3 months, as determined by the investigator, Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment

Exclusion Criteria

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, Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently), Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases, 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, Significant cardiovascular disease, 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

Study & Design

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