Docetaxel, Carboplatin, and Capecitabine as Treatment for Patients With Locally Advanced or Inflammatory Breast Cancer Before Surgery
Recruitment status was Active, not recruiting
The purpose of this study is to determine if this combination is safe and effective in this situation especially to increase the rate of pathological complete response (PCR). Women with large tumors and or lymph node involvement at the time of initial diagnosis may benefit from receiving chemotherapy prior to surgery to shrink the tumor and to decrease the amount of tumor involvement before surgery. If chemotherapy given before breast surgery is effective in decreasing the size of the tumor, breast conserving surgery (lumpectomy) may be possible. This new combination may be better tolerated than other commonly used regimens and, to date, appears to be at least as effective.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Neoadjuvant Trial of Docetaxel (Taxotere), Carboplatin, and Capecitabine (Xeloda) in the Treatment of Early Stage Locally Advanced and Inflammatory Breast Cancer|
- The primary objective of this study is to establish the pathological complete response rate (pCR) in the breast. The pCR is defined as the absence of invasive carcinoma.
- Establish pCR in breast and axillary lymph nodes
- Establish pCR in axillary lymph nodes
- Objective clinical response rate
- Rate of breast conserving surgery
- Time to disease progression
- Local control rates
|Study Start Date:||May 2003|
Neoadjuvant (primary) chemotherapy is being used more frequently in locally advanced breast cancer in an effort to reduce the size of the primary tumor prior to surgery and to eliminate micrometastatic disease.Through previous studies, it has been shown that patients who receive neoadjuvant therapy demonstrate prolonged disease-free survival when compared to those who did not have a pCR at the time of surgery.
It is proven that docetaxel is the single most active drug in metastatic breast cancer treatment and therefore has sparked interest in its use in the neoadjuvant setting. There have been studies conducted using docetaxel either alone or in combination in this setting and in one particular study showed that patients treated with docetaxel after an anthracycline –containing regimen achieved at 34% pCR compared to only 16% with the anthracycline-containing regimen alone. This drugs low incidence of neutropenia when administered on a weekly schedule, plus its possible synergistic effects with carboplatin and capecitabine lead to its inclusion in this neoadjuvant protocol.
Carboplatin is an agent that has recently been integrated into the front line of breast cancer treatment due to its response rate and tolerability. This drug as well has warranted further investigation in the neoadjuvant setting and was combined with docetaxel in one trial for for locally advanced disease which showed a preliminary pCR of the breast and axilla of 30% and 80% respectively. Due to its tolerability, minimal toxicities, and impressive results as a single agent and in combination with docetaxel made carboplatin a reasonable drug of choice in this study.
The novel oral agent capecitabine is being used in this protocol because it has shown through study to significantly increase response rate, time to progression, and even overall survival when combined with docetaxel in the metastatic setting. As well, capecitabine behaves similarly to continuous 5-FU infusion which has shown success in several phase II neoadjuvant trials and essentially has led to its inclusion in this study. Capecitabine’s anti-tumor activity, coupled with ease of administration, potential synergism with docetaxel and carboplatin, and non-overlapping toxicities justifies its inclusion in this investigational regimen.
|United States, Florida|
|Baptist Cancer Institute|
|Jacksonville, Florida, United States, 32207|
|Lakeland Regional Cancer Center|
|Lakeland, Florida, United States, 33805|
|Mount Sinai Comprehensice Cancer Center|
|Miami, Florida, United States, 33140|
|Oncology /Hematology Associates of Florida|
|Miami, Florida, United States, 33176|
|Cancer Research Network, Inc.|
|Plantation, Florida, United States, 33324|
|United States, Tennessee|
|Memphis, Tennessee, United States, 38120|
|Principal Investigator:||Sandra X Franco, MD||Cancer Research Network, Inc.|