OncRef

Clinical Trial: NCT02883062

Carboplatin and Paclitaxel With or Without Atezolizumab Before Surgery in Treating Patients With Newly Diagnosed, Stage II-III Triple-Negative Breast Cancer

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-09-30

Study Overview

Brief 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.

Official Title

Randomized Phase 2 Study of Neoadjuvant Chemotherapy, Carboplatin and Paclitaxel, With or Without Atezolizumab in Triple Negative Breast Cancer (TNBC)

Conditions

Invasive Breast Carcinoma, Stage II Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Triple-Negative Breast Carcinoma

Intervention / Treatment

  • Drug: Atezolizumab
  • Procedure: Biospecimen Collection
  • Drug: Carboplatin
  • Procedure: Lumpectomy
  • Procedure: Mastectomy
  • Drug: Paclitaxel

Other Study ID Numbers

  • NCI-2016-01301
  • NCI-2016-01301
  • 201706104
  • 10013
  • 10013
  • UM1CA186689
  • UM1CA186704

Start Date (Actual)

2017-08-02

Primary Completion Date (Actual)

2019-12-18

Study Completion Date (Estimated)

2027-09-30

Enrollment (Actual)

67

Study Type

Interventional

Phase

Phase 2