Status:
COMPLETED
A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several immunotherapy-based combination treatments in participants with inoperable locally advanced or metastatic HR-po...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Both Stages:
- Measurable disease per RECIST v1.1
- Adequate hematologic and end organ function
- Disease progression during or after first- or second-line hormonal therapy with CDK4/6 inhibitor
- Inclusion Criteria for Stage 1:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Metastatic or inoperable, locally advanced, histologically or cytologically confirmed invasive HR-positive HER2-negative breast cancer
- Recommended for endocrine therapy, and cytotoxic chemotherapy not indicated at study entry
- Recurrence or progression following most recent systemic breast cancer therapy
- Disease progression during or after first- or second-line hormonal therapy for locally advanced or metastatic disease
- Postmenopausal according to protocol-defined criteria
- Life expectancy \>3 months
- Available tumor specimen for determination of PD-L1 status
- Inclusion Criteria for Stage 2:
- ECOG performance status of 0-2
- Ability to initiate treatment within 3 months after disease progression or unacceptable toxicity on a Stage 1 regimen
- Exclusion Criteria for Both Stages:
- Significant or uncontrolled comorbid disease as specified in the protocol
- Uncontrolled tumor-related pain
- Autoimmune disease except for stable/controlled hypothyroidism, Type 1 diabetes mellitus, or certain dermatologic conditions
- Positive human immunodeficiency virus test
- Active hepatitis B or C
- Active tuberculosis
- Severe infection within 4 weeks and/or antibiotics within 2 weeks prior to study treatment
- Prior allogeneic stem cell or solid organ transplantation
- History of malignancy other than breast cancer within 2 years prior to screening except those with negligible risk of metastasis/death
- History of or known hypersensitivity to study drug or excipients
- For patients entering Stage 2, recovery from all immunotherapy-related adverse events to Grade 1 or better or to baseline at the time of consent
- Exclusion Criteria for Stage 1:
- Prior fulvestrant or cytotoxic chemotherapy for metastatic breast cancer, or certain other agents as specified in the protocol
- Unresolved AEs from prior anti-cancer therapy
- Eligibility only for the control arm
- Prior treatment with inhibitors as specified in the protocol
- Exclusion Criteria for Stage 2:
- Unacceptable toxicity with atezolizumab during Stage 1
- Uncontrolled cardiovascular disease or coagulation disorder, including use of anticoagulants as specified in the protocol
- Significant abdominal or intestinal manifestations within 6 months prior to treatment
- Grade 2 or higher proteinuria
Exclusion
Key Trial Info
Start Date :
December 22 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 26 2024
Estimated Enrollment :
144 Patients enrolled
Trial Details
Trial ID
NCT03280563
Start Date
December 22 2017
End Date
September 26 2024
Last Update
November 7 2025
Active Locations (22)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
2
UCSF Helen Diller Family CCC
San Francisco, California, United States, 94158
3
Stanford Cancer Institute
Stanford, California, United States, 94305-5456
4
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center
Torrance, California, United States, 90502