Clinical Trial: Phase II Neoadjuvant in Inflammatory Breast Cancer

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary: The goal of this clinical research study is to learn how well lapatinib taken alone, followed by taking lapatinib with paclitaxel, and then taking lapatinib with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC75) works to help to control Inflammatory Breast Cancer (IBC). The safety of this drug combination will also be studied.

Detailed Summary:

The Study Drugs:

Lapatinib is designed to prevent or slow down the growth of cancer cells by blocking proteins inside the cancer cell, called the Her2/neu receptor and the epidermal growth factor (EGFR).

Cyclophosphamide, paclitaxel, and 5-fluorouracil are designed to block cancer cells from dividing, which may slow or stop their growth and their ability to spread throughout the body. This may cause the cancer cells to die.

Epirubicin is designed to attach to DNA (the genetic material of cells) which may slow or stop their growth and cause them to die.

Study Drug Administration:

On Weeks 1-24 you will take lapatinib every day by mouth with water (about 8 ounces). It should be taken at least 1 hour before or at least 2 hours after eating. It is important that you take the study drug at about the same time every day. You should not eat pamelo fruit, grapefruit, star fruit, pawpaw, and/or drink their juices while on study.

If you forget to take a dose of the study drug, you should take the missed dose as soon as you remember, unless it has been more than 12 hours. If it has been more than 12 hours, do not take the missed dose. Instead, take the next dose as scheduled the next day. If you vomit after taking the study drug, wait until the next day to take your next dose.

The study drug should be stored at room temperature and out of direct sunlight. The study drug should be kept away from children. About every 3 weeks, you will need to bring back your empty or partially used bottle of study drug as instructed by your doctor.

On Weeks
Sponsor: M.D. Anderson Cancer Center

Current Primary Outcome: 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.


Original Primary Outcome: To learn how well lapatinib taken alone, followed by taking lapatinib with paclitaxel, and then taking lapatinib with 5-fluorouracil, epirubicin, and cyclophosphamide (FEC75) works to help to control IBC. [ Time Frame: 2 Years ]

Current Secondary Outcome: 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.


Original Secondary Outcome: The safety of this drug combination will also be studied. [ Time Frame: 2 Years ]

Information By: M.D. Anderson Cancer Center

Dates:
Date Received: September 19, 2008
Date Started: October 2008
Date Completion:
Last Updated: November 4, 2014
Last Verified: November 2014