OncRef

Clinical Trial: NCT00861705

Paclitaxel With or Without Carboplatin and/or Bevacizumab Followed by Doxorubicin and Cyclophosphamide in Treating Patients With Breast Cancer That Can Be Removed by Surgery

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:National Cancer Institute (NCI)
Information Provided By:National Cancer Institute (NCI)
Last Update Posted:2026-06-29

Study Overview

Brief Summary

This randomized phase II trial studies how well paclitaxel with or without carboplatin and/or bevacizumab followed by doxorubicin and cyclophosphamide works in treating patients with breast cancer that can be removed by surgery. Drugs used in chemotherapy, such as paclitaxel, carboplatin, doxorubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Bevacizumab may stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Official Title

Randomized Phase II 2 x 2 Factorial Trial of the Addition of Carboplatin +/- Bevacizumab to Neoadjuvant Weekly Paclitaxel Followed by Dose-Dense AC in Hormone Receptor-Poor/HER2-Negative Resectable Breast Cancer

Conditions

Male Breast Carcinoma, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage IIIA Breast Cancer AJCC v7, Triple-Negative Breast Carcinoma

Intervention / Treatment

  • Biological: Bevacizumab
  • Drug: Carboplatin
  • Drug: Cyclophosphamide
  • Drug: Doxorubicin Hydrochloride
  • Other: Laboratory Biomarker Analysis
  • Drug: Paclitaxel

Other Study ID Numbers

  • NCI-2009-01172
  • NCI-2009-01172
  • CALGB 40603/CTSU 40603
  • CALGB-40603
  • CDR0000636850
  • CALGB 40603
  • CALGB-40603
  • U10CA180821
  • U10CA031946

Start Date (Actual)

2009-07-21

Primary Completion Date (Actual)

2014-08-01

Study Completion Date (Actual)

2025-09-02

Enrollment (Actual)

454

Study Type

Interventional

Phase

Phase 2