Breast Cancer Clinical Trial
A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
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-positive, HER2-negative breast cancer who have progressed during or following treatment with a cyclin-dependent kinase (CDK) 4/6 inhibitor in the first- or second-line setting, such as palbociclib, ribociclib, or abemaciclib. The study will be performed in two stages. During Stage 1, participants will be randomized to fulvestrant (control) or an atezolizumab-containing doublet or triplet combination. Those who experience disease progression, loss of clinical benefit, or unacceptable toxicity may be eligible to receive a new triplet combination treatment in Stage 2 until loss of clinical benefit or unacceptable toxicity. New treatment arms may be added and/or existing treatment arms may be closed during the course of the study on the basis of ongoing clinical efficacy and safety as well as the current treatments available.
Eligibility Criteria
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
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There are 27 Locations for this study
Birmingham Alabama, 35249, United States
Los Angeles California, 90048, United States
San Francisco California, 94158, United States
Stanford California, 94305, United States
Torrance California, 90502, United States
West Hills California, 91307, United States
Marietta Georgia, 30060, United States
Chicago Illinois, 60612, United States
Baltimore Maryland, 21287, United States
New York New York, 10065, United States
Charlotte North Carolina, 28204, United States
Columbus Ohio, 43210, United States
Portland Oregon, 97231, United States
Harrisburg Pennsylvania, 17102, United States
Philadelphia Pennsylvania, 19107, United States
Pittsburgh Pennsylvania, 15213, United States
Nashville Tennessee, 37203, United States
Houston Texas, 77030, United States
Tacoma Washington, 98405, United States
Haifa , 31096, Israel
Jerusalem , 91031, Israel
Petach Tikva , 49414, Israel
Ramat Gan , 52621, Israel
Tel Aviv , 64239, Israel
Goyang-si , 10408, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 05505, Korea, Republic of
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