Nab-Paclitaxel and Atezolizumab Before Surgery in Treating Patients With Triple Negative Breast Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02530489
Phase
PHASE2
Status
Completed

Conditions

  • Breast Adenocarcinoma
  • Invasive Breast Carcinoma
  • Triple-Negative Breast Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Given IV
  • Nab-paclitaxel — DRUG
    Given IV

Study Details

This phase II trial studies how well nab-paclitaxel and atezolizumab before surgery work in treating patients with triple negative breast cancer (breast cancer cells that do not have estrogen receptors, progesterone receptors, or large amounts of human epidermal growth factor receptor 2 protein). Drugs used in chemotherapy, such as nab-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. 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. Giving nab-paclitaxel and atezolizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. This drug combination before surgery may be an effective treatment for triple negative breast cancer.

Key Dates

Start date
Feb 4, 2016
Status verified
Jan 2026
Primary completion
May 23, 2025
Completion
May 23, 2025

Study Design

Enrollment
37 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (atezolizumab, nab-paclitaxel)
    NEOADJUVANT: Patients receive atezolizumab IV over 60 minutes on day 1 and nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. SURGERY: Patients undergo definitive breast surgery within 6 weeks of the completion of treatment. ADJUVANT: Within 4 weeks after surgery, patients receive atezolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

RCB Status [ Time Frame: at the time of surgery, up to 12 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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M D Anderson Cancer Center· Houston, TX

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