Primary Chemotherapy With Docetaxel-Capecitabine and Doxorubicin-Cyclophosphamide in Breast Cancer

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-06-30

Study Completion Date

2008-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will assess the usefulness of a technique called complementary deoxyribonucleic acid (cDNA) microarray-an examination of a wide array of genes to identify disease-associated patterns-for measuring tumor response to chemotherapy in breast cancer patients. The study will look for "markers" that can help select the most effective type of chemotherapy. It will also evaluate the safety and effectiveness of a new drug combination of capecitabine and docetaxel.

Patients age 18 years and older with stage II or III breast cancer whose tumor is 2 centimeters or larger may be eligible for this study. Those enrolled will be treated with surgery, standard chemotherapy using doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan), and the capecitabine and docetaxel combination.

Patients will have a physical examination, mammogram and magnetic resonance imaging to evaluate their tumor before beginning treatment. They will then have four 21-day treatment cycles of docetaxel and capecitabine, as follows: docetaxel intravenously (through a vein) on day 1 and capecitabine pills (by mouth) twice a day from days 2 through 15. No drugs will be given from days 16 through 21. This regimen will be repeated four times, after which the tumor will be re-evaluated by physical examination, mammogram, and magnetic resonance imaging.

Patients will then have surgery to remove the cancer-either lumpectomy with removal of the underarm lymph nodes; mastectomy and removal of the underarm lymph nodes; or modified radical mastectomy. After recovery, they will have four more cycles of chemotherapy, this time with a doxorubicin and cyclophosphamide. Both drugs will be given intravenously on day 1 of four 21-day cycles.

Some patients who had a mastectomy (depending on their tumor characteristics and whether tumor cells were found in their lymph nodes) and all those who had a lumpectomy will also have radiation therapy. Patients with hormone receptor-positive tumors will also receive tamoxifen treatment for 5 years.

In addition to the above procedures, all patients will have tumor biopsies (removal of a small piece of tumor tissue) before beginning treatment, on day 1 of cycle 1, before cycle 2, and at the time of surgery, and physical examinations, chest X-rays, bone scans, computerized tomography (CT) scans, electrocardiograms, multi-gated acquisition scan-MUGA (nuclear medicine test of cardiac function) or echocardiograms of heart function, mammograms and blood tests at various times during the study. Patients will be followed at National Institutes of Health (NIH) for 3 years after diagnosis with physical examinations, blood tests, X-rays, and computed tomography (CT) scans.

Although it is not known whether this treatment will help an individual patient's cancer, possible benefits are tumor shrinkage and decreased risk of disease recurrence. In addition, the information gained about genetic changes after chemotherapy will help determine if additional studies on the use of cDNA microarray to measure tumor response are warranted.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Genomic & Proteomic Analysis of Docetaxel & Capecitabine as Primary Chemo for Stage II-III Breast Cancer

NCT00198237

Breast Cancer

COMPLETED PHASE2

Combination Chemotherapy in Treating Patients With Breast Cancer

NCT00003088

Breast Cancer

COMPLETED PHASE3

Combination Chemotherapy in Treating Women With Stage II or Stage IIIA Breast Cancer That Has Spread to the Lymph Nodes

NCT00004125

Breast Cancer

COMPLETED PHASE3

Evaluation of Differing Taxanes/Taxane Combinations on the Outcome of Patients With Operable Breast Cancer

NCT00050167

Breast Cancer

COMPLETED PHASE1

AZD2171 and Combination Chemotherapy in Treating Women With Locally Advanced Breast Cancer

NCT00310089

Breast Cancer

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer Breast Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine

Docetaxel 75 mg/m\^2 intravenous day 1, capecitabine 1000 mg/m\^2 orally twice daily day 2-15 for 4 cycles

Group Type EXPERIMENTAL

Docetaxel - Dose A

Intervention Type DRUG

Dose A-Cohort 1 Docetaxel 75 mg/m\^2 intravenous day 1

Anastrozole

Intervention Type DRUG

1 mg orally daily for five years

cyclophosphamide

Intervention Type DRUG

600 mg/m\^2 will be diluted in 100 mL 0.9% normal saline (NS) and administered intravenously over 30 minutes on day 1

Doxorubicin hydrochloride

Intervention Type DRUG

60 mg/m\^2 will be administered as a slow intravenous push on day 1

Tamoxifen Citrate

Intervention Type DRUG

20 mg/day orally for five years

Capecitabine - Dose A

Intervention Type DRUG

capecitabine 1000 mg/m\^2 orally twice daily day 2-15 for 4 cycles

Dose B-Cohort 2-Arm 2 Reduced dose-Docetaxel & Capecitabine

Docetaxel 60 mg/m\^2 intravenous day 1, capecitabine 937.5 mg/m\^2 orally twice daily day 2-15 for 4 cycles

Group Type EXPERIMENTAL

Anastrozole

Intervention Type DRUG

1 mg orally daily for five years

cyclophosphamide

Intervention Type DRUG

600 mg/m\^2 will be diluted in 100 mL 0.9% normal saline (NS) and administered intravenously over 30 minutes on day 1

Docetaxel - Dose B

Intervention Type DRUG

Dose B - Cohort 2 Docetaxel 60 mg/m\^2 intravenous day 1

Doxorubicin hydrochloride

Intervention Type DRUG

60 mg/m\^2 will be administered as a slow intravenous push on day 1

Tamoxifen Citrate

Intervention Type DRUG

20 mg/day orally for five years

Capecitabine - Dose B

Intervention Type DRUG

Dose B - Cohort 2 capecitabine 937.5 mg/m\^2 orally twice daily day 2-15

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Docetaxel - Dose A

Dose A-Cohort 1 Docetaxel 75 mg/m\^2 intravenous day 1

Intervention Type DRUG

Anastrozole

1 mg orally daily for five years

Intervention Type DRUG

cyclophosphamide

600 mg/m\^2 will be diluted in 100 mL 0.9% normal saline (NS) and administered intravenously over 30 minutes on day 1

Intervention Type DRUG

Docetaxel - Dose B

Dose B - Cohort 2 Docetaxel 60 mg/m\^2 intravenous day 1

Intervention Type DRUG

Doxorubicin hydrochloride

60 mg/m\^2 will be administered as a slow intravenous push on day 1

Intervention Type DRUG

Tamoxifen Citrate

20 mg/day orally for five years

Intervention Type DRUG

Capecitabine - Dose B

Dose B - Cohort 2 capecitabine 937.5 mg/m\^2 orally twice daily day 2-15

Intervention Type DRUG

Capecitabine - Dose A

capecitabine 1000 mg/m\^2 orally twice daily day 2-15 for 4 cycles

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Taxotere/Xeloda Arimidex Cytoxan Taxotere Adriamycin Nolvadex

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No