Carboplatin and Paclitaxel With or Without Atezolizumab Before Surgery in Treating Patients With Newly Diagnosed, Stage II-III Triple-Negative Breast Cancer
NCT02883062 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67
Last updated 2026-04-13
Summary
This phase II trial studies how well carboplatin and paclitaxel with or without atezolizumab before surgery works in treating patients with newly diagnosed, stage II-III triple negative breast cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carboplatin and paclitaxel with or without atezolizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Conditions
- Invasive Breast Carcinoma
- Stage II Breast Cancer AJCC v6 and v7
- Stage III Breast Cancer AJCC v7
- Triple-Negative Breast Carcinoma
Interventions
- DRUG
-
Given IV
- PROCEDURE
-
Biospecimen Collection
Undergo collection of blood samples
- DRUG
-
Given IV
- PROCEDURE
-
Lumpectomy
Undergo lumpectomy
- PROCEDURE
-
Mastectomy
Undergo mastectomy
- DRUG
-
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
lead NIH
Principal Investigators
-
William E Gillanders · Yale University Cancer Center LAO
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-08-02
- Primary Completion
- 2019-12-18
- Completion
- 2026-09-11
- FDA Drug
- Yes
Countries
- United States
Study Locations
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