Study on Carboplatin and Nab-Paclitaxel Before Surgery for Treating Locally Advanced or Inflammatory Triple Negative Breast Cancer
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT01525966
This clinical trial is testing how well the chemotherapy drugs carboplatin and nab-paclitaxel work when given before surgery to shrink tumors in patients with locally advanced or inflammatory triple negative breast cancer.
Patient Parameters
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Program Overview
The purpose of this study is to see if using the chemotherapy drugs carboplatin and nab-paclitaxel before surgery can effectively shrink tumors in patients with locally advanced or inflammatory triple negative breast cancer. These drugs work by stopping cancer cells from growing and spreading. By giving chemotherapy before surgery, the goal is to make the tumor smaller, which may help preserve more normal tissue during surgery.
Description
The main goals of this study are to see if the combination of carboplatin and nab-paclitaxel can lead to a complete response in the tumor before surgery and to evaluate the overall survival and event-free survival of patients. Researchers will also look at how well patients tolerate the treatment and any side effects they experience.
Additionally, the study will collect tissue and blood samples to analyze gene and protein expressions, which may help identify specific mutations and markers that could predict how well the treatment works or if the cancer might return. This information could also help find new targets for future therapies.
Patients in the study will receive carboplatin and nab-paclitaxel intravenously. The treatment is given in cycles, with each cycle lasting 28 days, and will be repeated for up to four cycles unless the disease progresses or side effects become too severe.
After completing the treatment, patients will have follow-up visits every three months for four years, then every six months for one year, and periodically after that to monitor their health and any long-term effects of the treatment.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with locally advanced or inflammatory triple negative breast cancer.
- Women of childbearing potential and men must agree to use effective contraception during the study and for six months after.
- Tumor must not express hormone receptors and must not over-express HER2.
- Blood tests must show adequate liver and kidney function, and sufficient blood cell counts.
- Heart function must be normal.
- Must not have received any prior treatment for the newly diagnosed breast cancer.
- Must be able to understand and sign a written informed consent.
Exclusion Criteria
- Active hepatitis B or C infection.
- Active HIV infection.
- Previous breast cancer or other invasive cancer treated within the last five years.
- Currently pregnant.
- Severe nerve damage (neuropathy).
- Any other medical or psychological condition that might interfere with the study, as determined by the doctor.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope Medical Center | 91010 | Duarte | California |
| City of Hope- South Pasadena Cancer Center | 91030 | South Pasadena | California |
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