A Trial of Paclitaxel and Bevacizumab vs. Gemcitabine, Paclitaxel, and Bevacizumab in Advanced Breast Cancer

Conditions

• Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• gemcitabine — DRUG
  1500 mg/m2, IV day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
• paclitaxel — DRUG
  90 mg/m2, IV, day 1, day 8 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity
• bevacizumab — DRUG
  10 mg/kg, IV, day 1 and day 15 every 28 days until complete response, disease progression or unacceptable toxicity

Study Details

This study will compare the cancer response to both treatments for locally advanced or metastatic breast cancer

Key Dates

First listed

May 3, 2006

Start date

May 31, 2006

Status verified

Jul 2013

Primary completion

Apr 30, 2009

Completion

Aug 31, 2012

Study Design

Enrollment

187 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: paclitaxel plus bevacizumab (PB)
  paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
• Experimental: paclitaxel plus bevacizumab plus gemcitabine (PB+G)
  paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: baseline & every 2 cycles (approximately 8 weeks) of treatment to measured progressive disease (PD) & post-therapy until PD or other therapy initiated (up to 35 months) ]

Locations (30)

Find similar trials in Fayetteville, AR

Related Studies

• Collecting Tissue Samples for Future Research From Women Undergoing Surgery for Breast Cancer
  Recruiting · Northwestern University · Chicago, Illinois
• Collecting and Storing Tissue Samples From Women With or Without Breast Cancer
  Recruiting · Vanderbilt-Ingram Cancer Center · Nashville, Tennessee
• Genetic & Pathological Studies of BRCA1/BRCA2: Associated Tumors & Blood Samples
  Recruiting · Stanford University · Stanford, California
• Magnetic Resonance Imaging of Breast Cancer
  Recruiting · Stanford University · Stanford, California