Study on Carboplatin and Paclitaxel With or Without Atezolizumab Before Surgery for Stage II-III Triple-Negative Breast Cancer
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02883062
This clinical trial is exploring whether adding the immunotherapy drug atezolizumab to the chemotherapy drugs carboplatin and paclitaxel before surgery can help treat patients with newly diagnosed stage II-III triple-negative breast cancer more effectively.
Patient Parameters
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Program Overview
The purpose of this study is to see if using the immunotherapy drug atezolizumab along with chemotherapy drugs carboplatin and paclitaxel before surgery can better control stage II-III triple-negative breast cancer. Atezolizumab may help the immune system attack cancer cells, while carboplatin and paclitaxel work to stop cancer cells from growing and spreading. This combination might shrink the tumor and reduce the amount of normal tissue that needs to be removed during surgery.
Description
The study aims to find out if combining chemotherapy with atezolizumab increases the number of immune cells attacking the tumor and improves the rate of complete tumor disappearance compared to chemotherapy alone. It will also evaluate the safety of this treatment combination.
Participants will be randomly assigned to one of two groups:
- Group A: Receives carboplatin and paclitaxel through an IV. This treatment is given every three weeks for up to four cycles, as long as the cancer does not progress or cause unacceptable side effects.
- Group B: Receives atezolizumab, carboplatin, and paclitaxel through an IV. This treatment is also given every three weeks for up to four cycles, under the same conditions.
After completing the treatment cycles, participants will undergo surgery to remove the tumor, either through a mastectomy or lumpectomy, within 3-6 weeks. Blood samples will be collected throughout the trial to monitor the body's response.
Participants will have follow-up visits at 6 months and 1 year after completing the study treatment to assess their health and the effectiveness of the treatment.
Eligibility Criteria
Inclusion Criteria
- Must have a new diagnosis of breast cancer confirmed by lab tests.
- Cancer must be triple-negative, meaning it does not have certain hormone receptors or HER2 protein.
- Cancer must be at stage II or III and eligible for chemotherapy before surgery.
- No previous treatment for this breast cancer.
- Age 18 or older.
- Must be in good overall health with a performance status score of 0 to 2.
- Must have adequate blood cell counts and organ function as determined by specific blood tests.
- Women of childbearing potential and men must agree to use effective contraception during the study and for 180 days after the last dose of paclitaxel.
- Must be able to understand and sign a written informed consent document.
Exclusion Criteria
- Known metastatic disease or cancer spread to other parts of the body.
- Cancer in the opposite breast.
- History of other cancers unless treated and disease-free for at least 1 year.
- Previous bone marrow or organ transplants.
- Recent treatment with other investigational drugs or immunosuppressive medications.
- Known allergies to study drugs or similar compounds.
- Significant liver disease or active infections.
- Autoimmune diseases or conditions affecting the immune system.
- Recent major surgery or live vaccinations.
- Pregnant or breastfeeding women.
- Uncontrolled health conditions that could interfere with the study.
- HIV-positive patients must be on a stable treatment regimen and have controlled viral load.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic Hospital in Arizona | 85054 | Phoenix | Arizona |
| Mayo Clinic in Arizona | 85259 | Scottsdale | Arizona |
| University of California Davis Comprehensive Cancer Center | 95817 | Sacramento | California |
| Mayo Clinic in Florida | 32224-9980 | Jacksonville | Florida |
| Johns Hopkins University/Sidney Kimmel Cancer Center | 21287 | Baltimore | Maryland |
| Siteman Cancer Center at Saint Peters Hospital | 63376 | City of Saint Peters | Missouri |
| Siteman Cancer Center at West County Hospital | 63141 | Creve Coeur | Missouri |
| Washington University School of Medicine | 63110 | St Louis | Missouri |
| Siteman Cancer Center-South County | 63129 | St Louis | Missouri |
| Siteman Cancer Center at Christian Hospital | 63136 | St Louis | Missouri |
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