NCT01205217

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

Randomized Study of Efficacy & Safety of Lapatinib & Epirubicin & Cyclophosphamide (EC90) Followed by Paclitaxel & Lapatinib Compared With EC90 Followed by Paclitaxel & Trastuzumab, as Neoadjuvant Therapy in Patients With Previously Untreated ErbB2-overexpressing Stage I - IIIA Breast Cancer.

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is a randomized, parallel-arm, open-label, multicentre, Phase II study to determine the efficacy and safety of lapatinib in combination with epirubicin and cyclophosphamide (EC90-L) followed by paclitaxel and lapatinib (PX-L) compared with EC90 followed by paclitaxel and trastuzumab (PX-T) as systemic neoadjuvant therapy for patients with previously untreated, operable, ErbB2-overexpressing, Stage I- IIIA breast cancer. Approximately 164 subjects will be enrolled in the study. Subjects will be randomised in a 1:1 ratio and stratified according to the following factors, each of which must be established prior to commencing randomisation: * Tumour size (≤ 2 cm versus \>2 cm in diameter). * Locally determined ER status (either ER positive or negative). Patients will be randomised to one of two treatment arms and will receive the following study treatments: Arm A: Experimental Arm (n=82) 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 (see Section 5.13.6) 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 (see Section 5.13.6) Arm B: Reference Arm (n=82): 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 The primary study period includes the screening phase, administration of randomized neo-adjuvant study treatment, and assessments up to the primary endpoint assessment at the time of definitive breast cancer surgery.

Conditions

• Neoplasms, Breast

Interventions

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

Timeline

• Start date: 2010-12-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2010-09-20
• Last updated: 2017-06-07

Locations

6 sites across 4 countries: Austria, Hungary, Norway, Spain