Researchers seek 240 women with metastatic, triple-negative breast cancer for a phase II study assessing the safety of different chemotherapy combinations and how well they prevent the worsening of the disease.
The trial team will compare outcomes among women taking:
- nab-paclitaxel (Abraxane) combined with either gemcitabine (Gemzar) or carboplatin
- gemcitabine and carboplatin combined
Background and Goals
Nab-paclitaxel and the combination of gemcitabine and paclitaxel are FDA approved for metastatic breast cancer that grew or spread after treatment with an anthracycline chemotherapy, such as doxorubicin (Adriamycin) or epirubicin (Ellence). Carboplatin (Paraplatin) is also FDA approved for other cancers, and is often used in metastatic breast cancer in combination with other chemotherapy medicines.
Nab-paclitaxel plus gemcitabine, one of the treatment options in this trial, is approved as first-line treatment for metastatic pancreatic cancer. The second option, nab-paclitaxel plus carboplatin, is also approved as first-line treatment, but for metastatic, non-small cell lung cancer.
Nab-paclitaxel is a form of paclitaxel given by vein. The paclitaxel binds to a protein called albumin that helps deliver the medicine to cancer cells. This delivery system reduces the risk of allergic reactions and eliminates the need to give steroid medicine to prevent an allergic reaction.
The trial team wants to know which nab-paclitaxel combination has better treatment results for triple-negative breast cancer, with fewer side effects. They plan to measure:
- progression-free survival, the time from the start of treatment until the disease grows or spreads or death from any cause
- overall response rate, how many tumors shrink or disappear after treatment, and
- overall survival, the time from the start of treatment until death from any cause.
When the better treatment is known, the research team will then test it in a phase III trial.
Participants will be assigned to one of three treatment groups, none of which are a placebo, or inactive substance. You and your doctor will know which treatment you are given. Possible groups are:
- 125 mg/m2 of nab-paclitaxel, given by vein for 30 minutes on days 1 and 8, followed by 1000 mg/m2 of gemcitabine given by vein for 30 minutes on days 1 and 8 every 21 days
- 125 mg/m2 of nab-paclitaxel, given by vein for 30 minutes on days 1 and 8, followed by carboplatin at a dose determined by your doctor after a blood test, given by vein for 1 hour on days 1 and 8 every 21 days
- 1000 mg/m2 of gemcitabine given by vein for 30 minutes on days 1 and 8, followed by carboplatin at a dose determined by your doctor after a blood test, given by vein for 1 hour on days 1 and 8 every 21 days
You may be able to take part in the study if you:
- are a woman 18 years of age or older
- have metastatic, triple-negative breast cancer, confirmed in your pathology report
- had early-stage cancer that spread to a distant site after taking anthracyclines, such as doxorubicin or epirubicin (Ellence)
- have not been treated with cytotoxic chemotherapies for metastatic breast cancer
- are not currently being treated with chemotherapy or radiation therapy
- completed any surgery at least 30 days before starting trial therapy
- have acceptable blood counts, as defined by the study
You may not be eligible if you:
- are currently using blood thinners, or used them within 7 days of starting trial treatment
- have brain metastases, or had them in the past
- have only metastases to bone
- were diagnosed with a non-breast cancer within the last 5 years
For more information, or to find out if you are eligible to enroll, talk with your doctor about trial NCT01881230 on clinicaltrials.gov.
This study is being held in 150 sites in the United States, Canada, Latin America and Europe. For a full list of locations and contact information, visit clinicaltrials.gov.