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Phase II Neoadjuvant Trial of Docetaxel (Taxotere), Carboplatin, and Capecitabine (Xeloda) in the Treatment of Early Stage Locally Advanced and Inflammatory Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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
investigational regimen.

Inclusion Criteria:

- Women or men > 18 years old with histologically confirmed, by needle core biopsy (not
FNA), locally advanced or inflammatory breast cancer.

- All patients must have either T2 lesion which is felt to be initially resectable only
through mastectomy by the surgeon, or with a T3 N0-N2; T4 any N; or any T with N2 or
N3 clinical evidence of disease. Stage 2 patients where breast conservation surgery
is desired but impractical at diagnosis because of anticipated poor cosmetic outcome
are eligible. Patients with inflammatory breast carcinoma and women with ipsilateral
supraclavicular node involvement are eligible. Patients must have measurable disease
defined as a breast lesion > 2 cm or with fixed or marked ipsilateral axillary nodes
and/or ipsilateral internal mammary nodes.

- Pre-and Post-menopausal female and male patients are eligible. Women of childbearing
potential must have a negative pregnancy test and, men and women must be willing to
consent to using effective dual methods of contraception while on treatment and for
three months thereafter.

- Life expectancy of greater than 6 months.

- Bone scan and CAT scan of chest and abdomen negative for metastatic disease

Exclusion Criteria:

- Patients with metastatic disease.

- Patients may not be receiving any other investigational agents.

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection other than mild resolving cellulitis, symptomatic congestive heart failure
(NYHA > Class 1), unstable angina pectoris, uncontrolled cardiac arrhythmia, known
coronary artery disease, or psychiatric illness/social situations that would limit
compliance with study requirements.

- Cancer other than breast primary within the last 5 years with the exception of
surgically cured non-melanoma skin cancer or in situ carcinoma of the cervix.

- Women who are breast-feeding.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Principal Investigator

Sandra X Franco, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Research Network, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

May 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • Neoadjuvant
  • Breast Cancer
  • pCR
  • Capecitabine
  • Carboplatin
  • Docetaxel
  • Breast Neoplasms
  • Inflammatory Breast Neoplasms



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