Conditions: Breast Cancer
Keywords: recurrent breast cancer stage IV breast cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 50
Healthy volunteers: no

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.

Arms:
arm 1: None

Interventions: intervention 1: Gemcitabine intervention 2: Paclitaxel protein-bound particles for injectable suspension (albumin-bound)
Intervention descriptions: intervention 1: 1000 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle intervention 2: 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle

Protocol document: