Lapatinib or Trastuzumab Given Prior to Surgery With Chemotherapy in Patients With Early Breast Cancer

Conditions

• Neoplasms, Breast

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lapatinib — DRUG
  Lapatinib 1000 mg orally once daily continuously
• Trastuzumab — DRUG
  Part II (Week 13-24) Trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV Day 1 of each week
• Epirubicin — DRUG
  Part I (Week 1-12) Epirubicin 90 mg/m2 by IV infusion on Day 1 every 21 days
• Cyclophosphamide — DRUG
  Part I (Week 1-12) Cyclophosphamide 600 mg/m2 by IV infusion on Day 1 every 21 days
• Paclitaxel — DRUG
  Part II (Week 13-24) Paclitaxel 80 mg/m2 by IV infusion on Day 1 of each week

Study Details

This study will test the safety of a drug called lapatinib and how well it works. Lapatinib (also called Tyverb or Tykerb) will be compared with another drug trastuzumab (also called Herceptin). Trastuzumab is an antibody against the HER2 protein. It binds to part of the HER2 protein to stop it working. Clinical trials have found that adding trastuzumab to chemotherapy lowers the rate of cancer recurrence and improves survival in women with HER2 positive breast cancer. Lapatinib also stops the HER2 protein working and may slow or stop cancer cells from growing and may prevent cancer from returning. Lapatinib has been approved in some countries to treat patients with certain types of breast cancer. However lapatinib has not been approved to treat early breast cancer. This study is one of many being carried out involving lapatinib in early breast cancer and these studies are showing that it is a promising treatment. This study will compare lapatinib and trastuzumab. One group of people will take lapatinib and another group will take trastuzumab. The effects of the drugs, both good and bad, will be compared. This study will compare two different durations of HER2 treatment to see if earlier introduction of HER2 treatment is beneficial. The lapatinib group will receive HER2 treatment from the very beginning for 24 weeks prior to surgery and the trastuzumab group will only receive HER2 therapy for 12 weeks prior to surgery.

Key Dates

Start date

Dec 31, 2010

Status verified

Jun 2017

Primary completion

Dec 31, 2010

Completion

Dec 31, 2010

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Arm A
  Lapatinib in combination with epirubicin and cyclophosphamide followed by paclitaxel and lapatinib. Part I (Week 1-12) Epirubicin 90 mg/m2 by IV infusion on Day 1 every 21 days Cyclophosphamide 600 mg/m2 by IV infusion on Day 1 every 21 days Lapatinib 1000 mg orally once daily continuously Loperamide as required for the proactive management of diarrhoea Part II (Week 13-24) Paclitaxel 80 mg/m2 by IV infusion on Day 1 of each week Lapatinib 1000 mg orally once daily continuously Loperamide as required for the proactive management of diarrhoea
• Active Comparator: Arm B
  Epirubicin and cyclophosphamide followed by paclitaxel and trastuzumab. Part I (Week 1-12) Epirubicin 90 mg/m2 by IV infusion on Day 1 every 21 days Cyclophosphamide 600 mg/m2 by IV infusion on Day 1 every 21 days Part II (Week 13-24) Paclitaxel 80 mg/m2 by IV infusion on Day 1 of each week Trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV Day 1 of each week

Primary Outcome Measure

Pathologic complete response (pCR) in the breast [ Time Frame: At the time of definitive surgery ]