Phase II Neoadjuvant Trial of Docetaxel (Taxotere), Carboplatin, and Capecitabine (Xeloda) in the Treatment of Early Stage Locally Advanced and Inflammatory Breast Cancer
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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Sandra X Franco, MD
Cancer Research Network, Inc.
United States: Food and Drug Administration
|Cancer Research Network, Inc.||Plantation, Florida 33324|
|Lakeland Regional Cancer Center||Lakeland, Florida 33805|
|Baptist Cancer Institute||Jacksonville, Florida 32207|
|Mount Sinai Comprehensice Cancer Center||Miami, Florida 33140|
|Oncology /Hematology Associates of Florida||Miami, Florida 33176|
|Sos/Acorn||Memphis, Tennessee 38120|