A Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Participants With Triple-Negative Breast Cancer

• Status: Recruiting
• Trial end date: 2022-03-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety, efficacy, and pharmacokinetics of tiragolumab in combination with atezolizumab and chemotherapy in participants with metastatic and early triple-negative breast cancer (TNBC).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Atezolizumab; Carboplatin; Cyclophosphamide; Doxorubicin; Lenograstim; Molgramostim; Paclitaxel; Sargramostim

Criteria

Inclusion Criteria

Cohort A:

• Metastatic or locally advanced unresectable, histologically documented TNBC characterized by absence of human epidermal growth factor 2 (HER2), estrogen receptor (ER), and progesterone receptor (PR) expression

• Only patients with metastatic TNBC tumors that are centrally tested and found to be programmed death-ligand 1 (PD-L1) positive will be enrolled

• No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC

• Eastern Cooperative Oncology Group performance status of 0 or 1

• Measurable disease, as assessed by the investigator according to RECIST v1.1

• Adequate hematologic and end-organ function

Cohort B:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Histologically documented TNBC (negative HER2, ER, and PR status)

• Confirmed tumor PD-L1 evaluation as documented through central testing of a representative tumor tissue specimen

• Primary breast tumor size of greater than (>) 2 centimeters (cm) by at least one radiographic or clinical measurement

• Stage at presentation: cT2-cT4, cN0-cN3, cM0

• Baseline left ventricular ejection fraction (LVEF) greater than or equal to (>/=) 53 percent (%) measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scans

• Adequate hematologic and end-organ function

Exclusion Criteria

Cohort A:

• Formalin-fixed, paraffin-embedded (FFPE) tumor tissue that is PD-L1 negative, as determined on the SP142 PD-L1 immunohistochemistry assay, with positivity defined as immune cells greater than or equal to (>/=) 1%

• Spinal cord compression not definitively treated with surgery and/or radiation or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for >2 weeks prior to initiation of study treatment

• Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases

• Leptomeningeal disease

Cohort B:

• History of invasive breast cancer

• Stage IV (metastatic) breast cancer

• Prior systemic therapy for treatment and prevention of breast cancer

• Previous therapy with anthracyclines, platinum, or taxanes for any malignancy

• Synchronous, bilateral invasive breast cancer

• Cardiopulmonary dysfunction