Phase II Neoadjuvant in Inflammatory Breast Cancer
|ClinicalTrials.gov Identifier: NCT00756470|
Recruitment Status : Terminated (Slow accrual.)
First Posted : September 22, 2008
Results First Posted : November 5, 2014
Last Update Posted : November 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Lapatinib Drug: Paclitaxel Drug: 5-Fluorouracil (5-FU) Drug: Epirubicin Drug: Cyclophosphamide||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||October 2013|
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.
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: Taxol
Drug: 5-Fluorouracil (5-FU)
500 mg/m^2 intravenously over 3-5 minutes every three weeks of Weeks 13-24.
75 mg/m^2 intravenously over 5-10 minutes every three weeks of Weeks 13-24.
500 mg/m^2 intravenously over 45-60 minutes every three weeks of Weeks 13-24.
- Rate of Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy [ Time Frame: Assessed at time of surgery following completion neoadjuvant chemotherapy (approximately 26 weeks) ]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) ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00756470
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ricardo Alvarez, MD||M.D. Anderson Cancer Center|