Study on Chemotherapy with Atezolizumab or Placebo Before and After Surgery for Triple-Negative Breast Cancer
Sponsor: NSABP Foundation Inc
ClinicalTrials ID:NCT03281954
This clinical trial is testing whether adding the drug atezolizumab to standard chemotherapy before surgery can better control triple-negative breast cancer compared to chemotherapy with a placebo. The study also examines the effects of continuing atezolizumab or placebo after surgery.
Patient Parameters
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Program Overview
The main goal of this study is to see if adding atezolizumab to the usual chemotherapy before surgery can reduce the tumor size in the breast and lower the chance of cancer returning after surgery in patients with triple-negative breast cancer. The usual chemotherapy includes drugs like paclitaxel, carboplatin, doxorubicin, and cyclophosphamide. After surgery, patients will continue to receive either atezolizumab or a placebo to see if it helps prevent cancer from coming back. The study will also look at the side effects of atezolizumab when combined with chemotherapy.
Description
This study, known as NSABP B-59/GBG 96-GeparDouze, is a Phase III clinical trial involving patients with high-risk triple-negative breast cancer. It is conducted by NSABP Foundation and the German Breast Group, with support from Genentech and Roche. The trial tests the effectiveness and safety of adding atezolizumab to standard chemotherapy before surgery and continuing it after surgery.
Participants will receive chemotherapy drugs paclitaxel and carboplatin, followed by doxorubicin and cyclophosphamide, along with either atezolizumab or a placebo. After surgery, they will continue with atezolizumab or placebo for about six months. Radiation therapy may be given based on local standards, and atezolizumab/placebo will be administered alongside it. If cancer remains after surgery, additional treatments like capecitabine or olaparib may be considered.
The study aims to determine if atezolizumab improves the complete response rate in the breast and lymph nodes and enhances event-free survival. Secondary goals include assessing overall survival, recurrence-free intervals, and safety. The study involves various tests and evaluations to monitor participants' health and treatment response.
Eligibility Criteria
Inclusion Criteria
- Must have signed consent to participate and provide tumor samples for research.
- Diagnosed with invasive breast cancer by core needle biopsy.
- Tumor must be ER-negative, PgR-negative, and HER2-negative based on local and central testing.
- Must be 18 years or older, male or female.
- ECOG performance status of 0-1.
- Tumor stage must meet specific criteria based on size and lymph node involvement.
- Blood counts and liver function tests must meet specified levels.
- Must have adequate kidney function and normal heart function.
- Women of childbearing potential must agree to use effective contraception during and after treatment.
- Must be willing to comply with study visits and procedures.
Exclusion Criteria
- Previous breast cancer surgery or treatment for the current diagnosis.
- History of other cancers within the last 5 years, except certain skin cancers.
- Heart disease or uncontrolled high blood pressure.
- Severe allergies to study drugs or components.
- Autoimmune diseases or immune deficiencies, with some exceptions.
- Active infections like hepatitis or tuberculosis.
- Recent severe infections or organ transplants.
- Use of certain medications or treatments that affect the immune system.
- Pregnancy or breastfeeding, or planning to become pregnant during the study.
- Participation in another clinical trial within the last 28 days.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| University of South Alabama Mitchell Cancer Institute | 36604 | Mobile | Alabama |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| St. Bernard's Medical Center | 72401 | Jonesboro | Arkansas |
| St. Bernard's Medical Center | 72450 | Paragould | Arkansas |
| Kaiser Permanente-Anaheim | 92806 | Anaheim | California |
| Kaiser Permanente-Baldwin Park | 91706 | Baldwin Park | California |
| Kaiser Permanente-Bellflower | 90706 | Bellflower | California |
| Arrowhead Regional Medical Center | 92324 | Colton | California |
| City of Hope | 91010 | Duarte | California |
| Kaiser Permanente-Fontana | 92335 | Fontana | California |
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