NCT00404066

Phase 2 Neoadjuvant Doxorubicin and Cyclophosphamide -> Docetaxel With Lapatinib in Stage II/III Her2Neu+ Breast Cancer

Phase II Neoadjuvant Chemotherapy Trial in Clinical Stage II/III Her2Neu Positive Breast Cancer With Sequential AC -> Docetaxel With Concurrent Dual EGFR Kinase Blockade by GW572016 (Lapatinib) Followed by 1 Year Adjuvant Trastuzumab

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: George Albert Fisher · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This trial combines dose dense chemotherapy with doxorubicin and cyclophosphamide (AC) followed by standard, every 3 week docetaxel and GW572016 (lapatinib) for neoadjuvant treatment of Her2neu positive stage II/III breast cancer. The purpose of the study was to determine whether lapatinib combined with chemotherapy was safe and resulted in an increase in pathologic complete response rates.

Detailed description

Lapatinib acts as a dual inhibitor of both epidermal growth factor receptor (EGFR) and ErbB-2 (Her2/neu) tyrosine kinase activity. EGFR and ErbB2 receptors are frequently over-expressed or altered in human cancers including breast cancer. This study plans to determine the antitumor activity of this regimen and its effectiveness preventing tumor growth and spread. Neoadjuvant chemotherapy which achieves pathologic complete responses (pCR) has been shown to predict improved long-term survival and serves as a surrogate for clinical outcome. By using this primary endpoint we can obtain statistical data with smaller patient numbers and at a lower overall cost. Additionally, we hope to correlate clinical and radiologic outcomes with gene expression data.

Conditions

• Breast Cancer
• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	Lapatinib	1250 mg, tablets, oral daily during treatment with docetaxel (3-week cycles x 4 cycles)
DRUG	Doxorubicin	60 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with cyclophosphamide.
DRUG	Cyclophosphamide	600 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with doxorubicin.
DRUG	Docetaxel	100 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide
DRUG	Pegfilgrastim	6 mg, subcutaneously on day 2 of all cytotoxic chemotherapy treatments.
DRUG	Filgrastim	300 or 480 mcg, subcutaneously on days 3 to 10 after cytotoxic chemotherapies.
DRUG	Dexamethasone	8 mg, oral taken twice a day for 3 days starting 24 hours before docetaxel
DRUG	Trastuzumab	Loading dose 8 mg/kg, then 6 mg/kg, intravenously every 3 weeks for 1 year

Timeline

• Start date: 2006-10-01
• Primary completion: 2010-12-01
• Completion: 2011-03-01
• First posted: 2006-11-27
• Last updated: 2017-12-22
• Results posted: 2017-12-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study