ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer

Phase 2

Completed

Interventions: Drug: Gemcitabine
Drug: Paclitaxel protein-bound particles for injectable suspension (albumin-bound)

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Nab-paclitaxel/Gemcitabine	Paclitaxel protein-bound particles for injectable suspension (albumin-bound)	-
Nab-paclitaxel/Gemcitabine	Gemcitabine	-

Primary Outcome Measures

Name	Time	Method
Proportion of Patients With Confirmed Responses	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 Outcome Measures

Name	Time	Method
Progression-free Survival	Time from registration to progression or death (up to 5 years)	Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation.
Overall Survival	Death or last follow-up (up to 5 years)	Overall survival time was defined as the number of days from registration to the date of death or last follow-up
Adverse Event	Every 6 weeks	Number of patients that experienced adverse events (grade 3 or more occurring in \>5% of patients) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0

Locations (196): Mobile Infirmary Medical Center
🇺🇸
Mobile, Alabama, United States
Mayo Clinic in Arizona
🇺🇸
Scottsdale, Arizona, United States
Aurora Presbyterian Hospital
🇺🇸
Aurora, Colorado, United States
Boulder Community Hospital
🇺🇸
Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital
🇺🇸
Colorado Springs, Colorado, United States
Porter Adventist Hospital
🇺🇸
Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center
🇺🇸
Denver, Colorado, United States
St. Joseph Hospital
🇺🇸
Denver, Colorado, United States
Rose Medical Center
🇺🇸
Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated
🇺🇸
Denver, Colorado, United States
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Mobile Infirmary Medical Center
🇺🇸Mobile, Alabama, United States