Lapatinib +/- Trastuzumab In Addition To Standard Neoadjuvant Breast Cancer Therapy.

Conditions

• Neoplasms, Breast

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Trastuzumab — DRUG
  4mg/kg IV loading dose followed by 2mg/kg IV weekly
• Paclitaxel — DRUG
  80mg/m2 IV weekly for 4 (21 day) cycles
• FEC75 — DRUG
  5FU 500mg/m2 + Epirubicin 75 mg/m2 + cyclophosphamide 500 mg/m2 IV on day 1 of 4 (21 day) cycles
• Lapatinib — DRUG
  1250 mg oral daily dose in arm 2, 750 mg oral daily dose for FEC cycles and then 1000 mg oral daily dose during the Paclitaxel cycles in arm 3

Study Details

This study will examine safety and efficacy of Lapatinib in combination with a standard neoadjuvant chemotherapy including 5FU, Epirubicin, Cyclophosphamide and Paclitaxel. Tumor tissue will be obtained at 3 timepoints (optional 4th) to evaluate tumor response to treatment.

Key Dates

Start date

Aug 31, 2007

Status verified

Mar 2016

Primary completion

Oct 31, 2010

Completion

Aug 31, 2015

Study Design

Enrollment

100 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Arm 1
  Trastuzumab alone for 2 weeks then in combination with FEC75 for 4 (21 Day) cycles and Paclitaxel for 4 (21 day) cycles then continued trastuzumab until time of definitive surgery
• Experimental: Arm 2
  Lapatinib alone for 2 weeks then in combination with FEC75 for 4 (21 Day) cycles followed by Paclitaxel for 4 (21 day) cycles then continued lapatinib until time of definitive surgery
• Experimental: Arm 3
  Trastuzumab + Lapatinib for 2 weeks then added FEC75 for 4 (21 Day) cycles followed by Paclitaxel for 4 (21 day) cycles then continued trastuzumab + lapatinib until time of definitive surgery

Primary Outcome Measure

Percentage of Participants With Overall Pathological Complete Response (pCR) After 26 Weeks of Therapy [ Time Frame: Week 26 ]

Locations (23)

Find similar trials in Fountain Valley, CA