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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
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

NCT03498716

TerminatedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Triple Negative Breast Cancer

Interventions: Atezolizumab, Paclitaxel, Dose-dense Doxorubicin or dose-dense Epirubicin, Cyclophosphamide

Countries: United States, Argentina, Australia, Austria, Belgium, Brazil, China, Czechia

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)

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria

* 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
Locations (364)
  • Concord, California, United States
  • Los Angeles, California, United States
  • St. Helena, California, United States
  • Jacksonville, Florida, United States
  • Chicago, Illinois, United States
  • Des Moines, Iowa, United States
  • Wichita, Kansas, United States
  • Baltimore, Maryland, United States
  • Edina, Minnesota, United States
  • Kansas City, Missouri, United States
  • Manchester, New Hampshire, United States
  • Lake Success, New York, United States
  • New York, New York, United States
  • Rochester, New York, United States
  • Nashville, Tennessee, United States
  • St. George, Utah, United States
  • Huntington, West Virginia, United States
  • Berazategui, Argentina
  • Ciudad Autonoma Buenos Aires, Argentina
  • Ciudad Autonoma Buenos Aires, Argentina
  • Córdoba, Argentina
  • La Rioja, Argentina
  • Rosario, Argentina
  • San Miguel de Tucumán, Argentina
  • San Salvador de Jujuy, Argentina
  • Viedma, Argentina
  • Darlinghurst, New South Wales, Australia
  • Lismore, New South Wales, Australia
  • Macquarie Park, New South Wales, Australia
  • Wahroonga, New South Wales, Australia
  • + 334 more on CT.gov