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A Pilot Trial of Sequential Primary (Neoadjuvant) Combination Chemotherapy With Docetaxel/Capecitabine (TX) and Doxorubicin/Cyclophosphamide (AC) in Primary Breast Cancer With Evaluation of Chemotherapy Effects on Gene Expression


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Breast Neoplasm

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Trial Information

A Pilot Trial of Sequential Primary (Neoadjuvant) Combination Chemotherapy With Docetaxel/Capecitabine (TX) and Doxorubicin/Cyclophosphamide (AC) in Primary Breast Cancer With Evaluation of Chemotherapy Effects on Gene Expression


This phase II trial in patients with stage II and stage III breast cancer will test the
feasibility of using cDNA microarray as a measure of a tumor's biological response to
chemotherapeutic agents by characterizing the cDNA expression patterns in breast cancer
before and after primary chemotherapy. Thirty-six patients receive docetaxel/capecitabine
induction chemotherapy followed by surgery and doxorubicin/cyclophosphamide adjuvant therapy
(TX/AC). We will determine the response rate of TX induction therapy and the toxicities of
the sequential combinations (TX/AC). We will also obtain tumor tissue for correlative
biological determinations.

Inclusion Criteria


- INCLUSION CRITERIA:

Stage II or III breast cancer with a tumor size of greater than 2 cm. Patients with a
previous biopsy are eligible provided adequate tumor tissue remains for biopsy in this
study.

At least 18 years of age.

Adequate hematopoietic function as defined by absolute neutrophil count greater than
1200/mm^3 and platelet count greater than 100,000/mm^3.

Adequate renal function as defined by creatinine less than 1.6 mg/dL.

Adequate hepatic function as defined by total (T.) bilirubin less than 1.4 mg/dL and serum
glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase (SGPT) less
than 1.5 times the upper limit of normal and alkaline phosphatase less than 2.5 times
upper limit of normal

Zubrod Performance status 0-2.

EXCLUSION CRITERIA:

Medical or psychiatric condition that, in the opinion of the Principal Investigator, would
preclude chemotherapy administration. Patients may be evaluated by psychiatry or medical
subspecialties as appropriate.

Pregnant or lactating women

Known bleeding disorders

Hypersensitivity to Tween 80 (Polysorbate)

Cardiac ejection fraction below normal limits, myocardial infarction within the past 12
months, or symptomatic arrhythmia requiring medical intervention.

Prior chemotherapy or hormonal therapy for breast cancer. Patients treated with hormonal
chemoprevention (tamoxifen or raloxifene) will be eligible.

Active malignancy diagnosed within the last 5 years. (Cervical cancer or non-melanomatous
skin cancer that has been treated with curative intent will be eligible).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Adverse Events

Outcome Description:

Here is the number of participants with adverse events. For the detailed list of adverse events see the adverse event module.

Outcome Time Frame:

6 years

Safety Issue:

Yes

Principal Investigator

JoAnne Zujewski, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI), National Institutes of Health (NIH)

Authority:

United States: Federal Government

Study ID:

000149

NCT ID:

NCT00005908

Start Date:

June 2000

Completion Date:

January 2008

Related Keywords:

  • Breast Cancer
  • Breast Neoplasm
  • cDNA Microarray
  • Stage II and Stage III Breast Cancer
  • Biological Response
  • Molecular Profiling
  • Fine Needle Aspirate
  • Breast Cancer
  • Breast Neoplasms
  • Neoplasms

Name

Location
National Naval Medical Center Bethesda, Maryland  20889