Phase II Neoadjuvant in Inflammatory Breast Cancer
Drug: 5-Fluorouracil (5-FU)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Neoadjuvant Lapatinib Plus Chemotherapy (Sequential FEC75 and Paclitaxel) in Women With Inflammatory Breast Cancer Whose Tumors Overexpress ErbB2 (Her2/Neu)|
- Rate of Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy [ Time Frame: Assessed at time of surgery following completion neoadjuvant chemotherapy (approximately 26 weeks) ] [ Designated as safety issue: No ]Pathologic complete response (pCR) rate defined as number of participants out of total that had no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy.
- Number of Participants With pCR After Completion of All Protocol Specified Therapy & Surgery (Surgical Population) [ Time Frame: Following definitive surgery at completion of neoadjuvant chemotherapy (following approximately 26 treatment weeks) ] [ Designated as safety issue: No ]Pathologic complete response [pCR or RCB Class 0] defined as no residual invasive disease (malignant cells) in the breast or axillary lymph nodes as assessed at the time of surgery following completion of all protocol specified neoadjuvant chemotherapy, which is approximately 26 weeks following the start of neoadjuvant chemotherapy and surgery. the residual cancer burden (RCB) was estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes. The calculated RCB index value is categorized as one of four RCB classes, RCB-0 to RCB-III where RCB-0 is best prognosis (no residual disease) to RCB-III a worst prognosis. The RCB score for participants was assessed following completion of all protocol specified therapy, 4 cycles of lapatinib and paclitaxel followed by 4 cycles of lapatinib plus FEC75 and surgery.
|Study Start Date:||October 2008|
|Study Completion Date:||October 2013|
|Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: Neoadjuvant Lapatinib plus Chemotherapy
Four cycles of Lapatinib and Paclitaxel followed by 4 cycles of Lapatinib plus 5-Fluorouracil, Cyclophosphamide, Epirubicin (FEC75). Cycle is 21 days.
Lapatinib alone at 1,000 mg orally once daily for a 2-week run-in period, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each.
1000 mg taken by every day by mouth (PO) weeks 1 and 2; then starting day 15 for 12 weeks (weeks 3 to 14) daily 750 mg PO. Week 15, second combination treatment consisting of lapatinib (1,000 mg orally once daily) combined with FEC7.
Other Names:Drug: Paclitaxel
80 mg/m^2 intravenously over 1 hour weekly for 4 cycles administered on Day 1, Day 8, and Day 15 of each cycle then weekly starting day 15 for 12 weeks.
Other Name: TaxolDrug: 5-Fluorouracil (5-FU)
500 mg/m^2 intravenously over 3-5 minutes every three weeks of Weeks 13-24.
Other Names:Drug: Epirubicin
75 mg/m^2 intravenously over 5-10 minutes every three weeks of Weeks 13-24.Drug: Cyclophosphamide
500 mg/m^2 intravenously over 45-60 minutes every three weeks of Weeks 13-24.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT00756470
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ricardo Alvarez, MD||M.D. Anderson Cancer Center|