Phase 2 Neoadjuvant Doxorubicin and Cyclophosphamide -> Docetaxel With Lapatinib in Stage II/III Her2Neu+ Breast Cancer
|ClinicalTrials.gov Identifier: NCT00404066|
Recruitment Status : Completed
First Posted : November 27, 2006
Results First Posted : December 22, 2017
Last Update Posted : December 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Metastatic Breast Cancer||Drug: Lapatinib Drug: Doxorubicin Drug: Cyclophosphamide Drug: Docetaxel Drug: Pegfilgrastim Drug: Filgrastim Drug: Dexamethasone Drug: Trastuzumab||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||March 2011|
Experimental: Neoadjuvant Chemotherapy
Doxorubicin (Adriamycin) + cyclophosphamide (Cytoxan) with pegfilgrastim or filgrastim growth factor support every 2 weeks for 4 cycles, followed by docetaxel + lapatinib for four 21-day cycles, followed by surgery. Dexamethasone was administered twice-a-day for 3 days, starting 24 hours before the docetaxel infusions. After surgery +/- radiation, participants may receive trastuzumab (Herceptin) for a year.
1250 mg, tablets, oral daily during treatment with docetaxel (3-week cycles x 4 cycles)
Other Name: GW572016
60 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with cyclophosphamide.
600 mg/m2, intravenously every 2 weeks for 4 cycles. Given as first treatment with doxorubicin.
100 mg/m2, intravenously every 3 weeks for 4 cycles (after treatment cycles of doxorubicin and cyclophosphamide
Other Name: Taxotere
6 mg, subcutaneously on day 2 of all cytotoxic chemotherapy treatments.
Other Name: Neulasta
300 or 480 mcg, subcutaneously on days 3 to 10 after cytotoxic chemotherapies.
8 mg, oral taken twice a day for 3 days starting 24 hours before docetaxel
Other Name: Adexone
Loading dose 8 mg/kg, then 6 mg/kg, intravenously every 3 weeks for 1 year
Other Name: Herceptin
- Percentage of Participants With Pathologic Complete Response (pCR) [ Time Frame: 12 weeks ]Pathologic Complete Response (pCR) rate, assessed as no evidence of invasive disease in excised surgical specimens of breast and/or axilla, in participants who received at least 1 cycle of docetaxel and lapatinib and at least one follow-up evaluation.
- Disease-free Survival (DFS) [ Time Frame: 42 months (median follow-up) ]Disease-free survival (DFS) is expressed as the percentage of participants who were disease-free and alive at the time of analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00404066
|United States, California|
|Santa Clara Valley Medical Center|
|San Jose, California, United States, 95128|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||George A Fisher, MD, PhD||Stanford University|