Brain Metastases In ErbB2-Positive Breast Cancer

Conditions

• Neoplasms, Breast

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• capecitabine — DRUG
  capecitabine 2000mg/m2/day orally, Days 1-14, every 21 days
• topotecan — DRUG
  topotecan intravenous (IV, in the vien) 3.2mg/m2 Days 1, 8 and 15; every 28 days
• lapatinib — DRUG
  lapatinib administered 1250mg once daily orally

Study Details

This study is for patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. The study will determine how safe and effective lapatinib is when given in combination with capecitabine to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed regularly during the course of the study.

Key Dates

Start date

May 31, 2007

Status verified

Oct 2012

Primary completion

Jan 31, 2009

Completion

Feb 28, 2010

Study Design

Enrollment

22 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: lapatinib plus capecitabine
  A total of 55 isubjects will be enrolled into this arm. Subjects with progression of CNS and/or non-CNS disease will be considered progressors. At the time of radiographically-documented CNS and/or non-CNS disease progression, a subject randomized to this arm will be allowed to cross over to the alternative arm.
• Experimental: lapatinib + topotecan
  A total of 55 isubjects will be enrolled into this arm. Subjects with progression of CNS and/or non-CNS disease will be considered progressors. At the time of radiographically-documented CNS and/or non-CNS disease progression, a subject randomized to this arm will be allowed to cross over to the alternative arm.

Primary Outcome Measure

Number of Participants With the Indicated Central Nervous System (CNS) Objective Response (OR) [ Time Frame: From the start of treatment until disease progression, death, or discontinuation from the study, up to a maximum of Week 88 ]

Locations (13)

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