Study on Nab-Paclitaxel for Treating Older Patients with Advanced or Metastatic Breast Cancer
Sponsor: City of Hope Medical Center
ClinicalTrials ID:NCT01463072
This clinical trial is examining the side effects and effectiveness of the chemotherapy drug nab-paclitaxel in older adults with breast cancer that has spread locally or to other parts of the body.
Patient Parameters
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Program Overview
The purpose of this study is to investigate the side effects and effectiveness of nab-paclitaxel, a chemotherapy drug, in treating older patients with breast cancer that has spread either locally or to other parts of the body. Nab-paclitaxel works by stopping cancer cells from growing, dividing, or spreading.
Description
The main goal of this study is to see how well older adults tolerate nab-paclitaxel, focusing on side effects like nerve damage and the need to adjust doses. Researchers also want to see how effective the drug is in shrinking tumors and delaying cancer progression. The study will include patients aged 65 and older, with a focus on those aged 75 and above.
Participants will receive nab-paclitaxel through an IV on days 1, 8, and 15 of each 28-day cycle, as long as the cancer does not progress and side effects are manageable. After finishing the treatment, patients will have regular follow-up visits to monitor their health.
Eligibility Criteria
Inclusion Criteria
- Have locally advanced or metastatic breast cancer.
- Any status of estrogen, progesterone, or HER2 receptors, as long as nab-paclitaxel is the only treatment.
- Receiving first or second line chemotherapy for metastatic cancer.
- Have a performance status score of 70% or higher, indicating good general health.
- Have resolved any significant side effects from previous treatments, except hair loss.
- Have mild or no nerve damage.
- Have adequate blood cell counts and liver function as determined by specific tests.
- Have a creatinine clearance of 30 ml/min or higher, indicating good kidney function.
- Be able to understand and sign a consent form.
Exclusion Criteria
- Cannot be taking other experimental drugs.
- Cannot have untreated or worsening brain metastases requiring increasing doses of steroids.
- Cannot have a known allergy to paclitaxel.
- Cannot have serious or uncontrolled infections.
- Cannot have received a taxane drug for breast cancer in the past 12 months.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| City of Hope medical | 91010 | Duarte | California |
| City of Hope Antelope Valley | 93534 | Lancaster | California |
| City of Hope South Pasadena | 91030 | South Pasadena | California |
| Ohio State University Comprehensive Cancer Center | 43210 | Columbus | Ohio |
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