Pazopanib Plus Lapatinib Compared To Lapatinib Alone In Subjects With Inflammatory Breast Cancer

Conditions

• Neoplasms, Breast

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• lapatinib — DRUG
  Oral administration
• Pazopanib — DRUG
  Oral administration

Study Details

The double blind part of the study is being conducted to compare the efficacy and safety of pazopanib in combination with lapatinib with that of lapatinib alone in subjects with inflammatory breast cancer whose tumors overexpress the ErbB2 protein. There is also an Open-label pazopanib arm to this study designed to test whether pazopanib given alone and lapatinib given alone would be safe and effective to treat patients with inflammatory breast cancer.

Key Dates

Start date

Dec 31, 2007

Status verified

Jan 2013

Primary completion

May 31, 2011

Completion

Dec 31, 2011

Study Design

Enrollment

163 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: arm 1
  Lapatinib
• Active Comparator: arm2
  Pazopanib monotherapy (open label)
• Experimental: arm3
  Lapatinib+ pazopanib

Primary Outcome Measure

Number of Participants With Overall Response (OR), Defined as Those Participants Achieving Complete Response (CR) or Partial Response (PR), Assessed Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 and Cutaneous Lesions [ Time Frame: Baseline until disease progression/recurrence was documented, assessed for up to 66 weeks ]

Locations (17)

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