A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL 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

Not Applicable

• Conditions: -C50 Malignant neoplasm of breast; Malignant neoplasm of breast; C50

• Registration Number: PER-055-18
• Lead Sponsor: F. HOFFMANN-LA ROCHE LTD.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-29
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

-Signed Informed Consent Form (ICF)
-Ability to comply with protocol, in the investigator’s judgment
-Women or men aged  18 years at time of signing ICF
-Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
-Non-metastatic operable Stage IIIII breast cancer
-Histologically documented TNBC (negative HER2, ER, and PgR status)
-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.
Additional information, please see the Protocol.

Exclusion Criteria

-Prior history of invasive breast cancer
-Any T4 clinical tumor as defined by tumor-node metastasis classification in UICC/AJCC, 8th edition, including inflammatory 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 (e.g., trastuzumab, trastuzumab emtansine, pertuzumab, lapatinib, neratinib, or other tyrosine kinase inhibitors), hormonal therapy, or anti-cancer RT other than planned in the context of this study and described in Appendix 8.
-Previous therapy with anthracyclines or taxanes for any malignancy
-History of DCIS and/or LCIS that was treated with any form of systemic, hormonal therapy, or RT to the ipsilateral breast where invasive cancer subsequently developed
-Contraindication to RT when adjuvant RT is clinically indicated
-Cardiopulmonary dysfunction as defined by any of the following prior to randomization.
Additional information, please see the Protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified