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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02883062
Phase
PHASE2
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

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

Interventions

  • Atezolizumab — DRUG
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Carboplatin — DRUG
    Given IV
  • Lumpectomy — PROCEDURE
    Undergo lumpectomy
  • Mastectomy — PROCEDURE
    Undergo mastectomy
  • Paclitaxel — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Aug 2, 2017
Status verified
Mar 2026
Primary completion
Dec 18, 2019
Completion
Sep 11, 2026

Study Design

Enrollment
67 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A (carboplatin, paclitaxel, mastectomy, lumpectomy)
    Patients receive carboplatin IV over 30 minutes Q3W and paclitaxel IV over 1 hour QW. Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo the collection of blood samples throughout the trial.
  • Experimental: Arm B (atezolizumab, carboplatin, paclitaxel, breast surgery)
    Patients receive atezolizumab IV over 30-60 minutes and carboplatin IV over 30 minutes Q3W, and paclitaxel IV over 1 hour QW. Treatment repeats every 3 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo the collection of blood samples throughout the trial.

Primary Outcome Measure

Change in Tumor Infiltrating Lymphocyte (TIL) Percentage [ Time Frame: Baseline and between days 18-22 following completion of cycle 1 (each cycle is 3 weeks) ]

Locations (14)

FacilityCityStateZIPSite coordinators
Mayo Clinic Hospital in ArizonaPhoenixArizona85054-
Mayo Clinic in ArizonaScottsdaleArizona85259-
University of California Davis Comprehensive Cancer CenterSacramentoCalifornia95817-
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980-
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Siteman Cancer Center at Saint Peters HospitalCity of Saint PetersMissouri63376-
Siteman Cancer Center at West County HospitalCreve CoeurMissouri63141-
Siteman Cancer Center at Christian HospitalSt LouisMissouri63136-
Siteman Cancer Center-South CountySt LouisMissouri63129-
Washington University School of MedicineSt LouisMissouri63110-
UNC Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27599-
Duke University Medical CenterDurhamNorth Carolina27710-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic Hospital in Arizona· Phoenix, AZMayo Clinic in Arizona· Scottsdale, AZUniversity of California Davis Comprehensive Cancer Center· Sacramento, CAMayo Clinic in Florida· Jacksonville, FLJohns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MDSiteman Cancer Center at Saint Peters Hospital· City of Saint Peters, MO

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