A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer

Stopped early · Phase 3

Conditions studied: Triple Negative Breast Cancer

In brief

This study will evaluate the efficacy, safety, and pharmacokinetics of adjuvant atezolizumab in combination with paclitaxel, followed by atezolizumab, dose-dense doxorubicin or epirubicin (investigator's choice), and cyclophosphamide, compared with paclitaxel followed by dose-dense doxorubicin or epirubicin (investigator's choice) and cyclophosphamide alone in patients with Stage II-III TNBC (Triple Negative Breast Cancer)

Key facts

Study ID

NCT03498716

Run by

Hoffmann-La Roche

People needed

2199

Starts

2018-08-02

Expected to finish

2023-08-14

Last updated by the study team

2024-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Non-metastatic operable Stage II-III breast cancer
• Histologically documented TNBC (Triple Negative Breast Cancer)
• Confirmed tumor PD-L1 evaluation as documented through central testing of a representative tumor tissue specimen
• Adequately excised: Patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy
• Adequate hematologic and end-organ function
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm.
• No more than 8 weeks (56 days) may elapse between definitive breast surgery and randomization.
• Representative formalin-fixed, paraffin embedded (FFPE) tumor specimen from surgical resection in paraffin blocks (preferred) or at least 25 unstained slides.

You may not qualify if…

• Prior history of invasive breast cancer
• For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy, anti-HER2 therapy.
• Previous therapy with anthracyclines or taxanes for any malignancy
• Cardiopulmonary dysfunction
• Prior malignancies within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome
• Active or history of autoimmune disease or immune deficiency
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
• Urinary outflow obstruction
• Active tuberculosis
• Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during study treatment or within 5 months following the last dose of Atezolizumab (for patients randomized to Atezolizumab)
• Prior allogeneic stem cell or solid organ transplant
• Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment or anticipation of need for systemic immunosuppressive medication during the study

Where it is running

• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Martin-O?Neil Cancer Center — St. Helena, California, United States
• Baptist - MD Anderson Cancer Center — Jacksonville, Florida, United States
• Advocate Illinois Masonic Outpatient Center for Advanced Care — Chicago, Illinois, United States
• Des Moines Oncology Research Association — Des Moines, Iowa, United States
• Cancer Center of Kansas — Wichita, Kansas, United States
• University of Maryland Greenebaum Comprehensive Cancer Center — Baltimore, Maryland, United States
• Fairview Southdale Medical Oncology Clinic — Edina, Minnesota, United States
• HCA Midwest Division — Kansas City, Missouri, United States
• New Hampshire Hematology Oncology — Manchester, New Hampshire, United States
• Monter Cancer Center — Lake Success, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Rochester General Hospital; Lipson Cancer and Blood Center — Rochester, New York, United States
• SCRI — Nashville, Tennessee, United States
• Intermountain Precision Genomics Cancer Research Clinic-Dixie — St. George, Utah, United States
• St. Mary's Medical Center — Huntington, West Virginia, United States
• Centro de Oncologia e; Investigacion Buenos Aires - COIBA — Berazategui, Argentina
• INSTITUTO DE INVESTIGACIONES METABOLICAS (IDIM); Oncology — Ciudad Autonoma Buenos Aires, Argentina
• Hospital Britanico de Buenos Aires — Ciudad Autonoma Buenos Aires, Argentina
• Clinica Universitaria Reina Fabiola — Córdoba, Argentina
• Centro Oncologico Riojano Integral (CORI) — La Rioja, Argentina
• Instituto de Oncología de Rosario — Rosario, Argentina
• Centro Medico San Roque — San Miguel de Tucumán, Argentina
• Fundación Ars Medica — San Salvador de Jujuy, Argentina
• John Muir Health Clinical Research Center — Concord, California, United States

Full record on ClinicalTrials.gov

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