West Cancer Center

Breast: metastatic ER+, Her2 negative first or second line MORPHEUS-BREAST

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)

Title

ROCHE CO42867 Breast Cancer MORPHEUS BREAST

Study 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)

Site Link

NCT04802759

Malignancy

breast cancer

Stage

Stage 4

Disease Setting

metastatic

Line Of Therapy

first or second

Investigational Agent

Giredestrant, Abemaciclib, Ipatasertib, Inavolisib, Ribociclib, Everolimus

Drug Class

multiple

Gregory Vidal, MD

Sponsor

Hoffmann-La Roche

Phase

Phase 2

Status

Open to Enrollment

Key Eligibility Criteria

Key Eligibility Criteria Details

ER+, Her2 negative breast cancer
Endocrine therapy recommended, cytotoxic chemotherapy not recommended
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
ECOG 0-1
Available tumor specimen
Prior fulvestrant therapy is allowed
Measurable disease
No prior cytotoxic chemotherapy for metastatic disease
For patients receiving therapeutic anticoagulation: stable anticoagulant regimen

Objective

Primary Objective: 1) Objective Response 2) Adverse Events

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

ER+

Dosing Frequency

Control Agents

Study Protocol

Randomized