Docetaxel, Carboplatin, and Capecitabine as Treatment for Patients With Locally Advanced or Inflammatory Breast Cancer Before Surgery

NCT00251329 | Unknown Phase 2

• 1 other identifier: CRN-004
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Neoadjuvant; Breast Cancer; pCR; Capecitabine; Carboplatin; Docetaxel

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (7)

• Establish pCR in breast and axillary lymph nodes

• Establish pCR in axillary lymph nodes

• Objective clinical response rate

• Tolerability

• Rate of breast conserving surgery

Interventions

neoadjuvant chemotherapy DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Research Network: lead
• Sanofi: collaborator

Study Sites (6)

Baptist Cancer Institute

Jacksonville, Florida, 32207, United States

Location

Lakeland Regional Cancer Center

Lakeland, Florida, 33805, United States

Location

Mount Sinai Comprehensice Cancer Center

Miami, Florida, 33140, United States

Location

Oncology /Hematology Associates of Florida

Miami, Florida, 33176, United States

Location

Cancer Research Network, Inc.

Plantation, Florida, 33324, United States

Location

Sos/Acorn

Memphis, Tennessee, 38120, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics

Study Officials

• Sandra X Franco, MD

  Cancer Research Network, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 8, 2005
• First Posted: November 10, 2005
• Study Start: May 1, 2003
• Last Updated: April 4, 2007

Record last verified: 2007-04

Locations

US (6)