Lapatinib In Combination With Chemotherapy In Subjects With Relapsed Breast Cancer

Conditions

• Neoplasms, Breast
• Relapsed Breast Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lapatinib — DRUG
  Small molecule tyrosine kinase inhibitor
• Capecitabine — DRUG
  Chemotherapy
• Docetaxel — DRUG
  Chemotherapy
• nab-Paclitaxel — DRUG
  Chemotherapy

Study Details

This study will evaluate the safety and efficacy of lapatinib in combination with chemotherapy (capecitabine, docetaxel, nab-paclitaxel) in subjects with ErbB2-overexpressing breast cancer whose disease has progressed during or within 12 months after completion of trastuzumab-containing therapy in the neoadjuvant or adjuvant setting.

Key Dates

Start date

Nov 30, 2007

Status verified

Jun 2011

Primary completion

Sep 30, 2009

Completion

Mar 31, 2010

Study Design

Enrollment

9 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Lapatinib plus Chemotherapy
  Lapatinib is administered in combination with one of the following chemotherapies based on the discretion of the investigator : capecitabine, docetaxel or nab-paclitaxel.

Primary Outcome Measure

Overall Tumor Response [ Time Frame: from start of treatment and every 6 weeks (wks) until Wk 12, then every 12 wks thereafter through the end of treatment (~95 wks; dependent on when participant discontinued study therapy due to disease progression, death, adverse event, of other reason) ]

Locations (28)

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