A Study Of SU011248 Plus Paclitaxel Versus Bevacizumab Plus Paclitaxel In Patients With Advanced Breast Cancer

Conditions

• Breast Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Sunitinib — DRUG
  Sunitinib 25 mg daily by oral capsules with titration up to 37.5 mg,
• paclitaxel — DRUG
  Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.
• bevacizumab — DRUG
  Bevacizumab 10 mg/kg IV every 2 weeks.
• paclitaxel — DRUG
  Paclitaxel 90 mg/m2 IV, 3 weekly doses every 28 days until progression or unacceptable toxicity.

Study Details

To compare treatment with SU011248 plus paclitaxel versus bevacizumab plus paclitaxel to determine which treatment works better against breast cancer

Key Dates

First listed

Sep 8, 2006

Start date

Nov 30, 2006

Status verified

Sep 2012

Primary completion

Jun 30, 2009

Completion

Aug 31, 2011

Study Design

Enrollment

488 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: A
• Active Comparator: B

Primary Outcome Measure

Progression-Free Survival (PFS) [ Time Frame: From date of randomization through Day 1 and every 8 weeks thereafter up to 18 months or death ]

Locations (241)

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