Phase II Trial of Weekly Nab (Nanoparticle Albumin Bound)-Paclitaxel (Nab-paclitaxel) (Abraxane®) in Combination With Gemcitabine in Patients With Metastatic Breast Cancer
Overview
- Phase
- Phase 2
- Intervention
- Gemcitabine
- Conditions
- Breast Cancer
- Sponsor
- Mayo Clinic
- Enrollment
- 50
- Locations
- 196
- Primary Endpoint
- Proportion of Patients With Confirmed Responses
- Status
- Completed
- Last Updated
- 14 years ago
Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as ABI-007(Nab-Paclitaxel((Nanoparticle Albumin Bound)-Paclitaxel)) and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine works in treating women with metastatic breast cancer.
Detailed Description
OBJECTIVES: Primary * Determine the antitumor activity of ABI-007 and gemcitabine, in terms of response rate in women with metastatic breast cancer. * Determine the toxicity profile of this regimen, in terms of incidence and severity of observed toxic effects, in these patients. Secondary \* Determine the time to disease progression and survival of patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive ABI-007 IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for up to 5 years. PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study within 20 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Nab-paclitaxel/Gemcitabine
Intervention: Gemcitabine
Nab-paclitaxel/Gemcitabine
Intervention: Paclitaxel protein-bound particles for injectable suspension (albumin-bound)
Outcomes
Primary Outcomes
Proportion of Patients With Confirmed Responses
Time Frame: Two consecutive evaluations at least 6 weeks apart
Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart. Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.
Secondary Outcomes
- Progression-free Survival(Time from registration to progression or death (up to 5 years))
- Overall Survival(Death or last follow-up (up to 5 years))
- Adverse Event(Every 6 weeks)