Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer

Emory University

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Capecitabine; Drug: Docetaxel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00209092

1114-2003

Details and patient eligibility

About

The purpose of this study is to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

Full description

The purpose of this study is to identify new chemotherapy treatment regimens with better response rates and to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

Induction chemotherapy offers the possibility of less surgery and determines tumor sensitivity in vivo. Previous trials have demonstrated that complete pathologic response in the breast at surgery corresponds with improved outcome. Additionally, we will correlate specific molecular markers in the breast tumors before and after chemotherapy, with response to treatment. Expression of these molecular markets may be used in the future to predict the likelihood of response to chemotherapy given post-operatively.

Enrollment: 51 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed breast carcinoma.
• Early stage breast cancer (stage 1, 2, 3).
• No evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.
• 18 years of age or older.
• Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Exclusion criteria

• Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer.
• Major surgery within 28 days of study entry.
• Evidence of central nervous system (CNS) metastases.
• Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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51 participants in 2 patient groups

Sequential Therapy

Active Comparator group

Description:

Docetaxel will be given at 100mg/m\^2 intravenous Day 1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).

Treatment:

Drug: Capecitabine

Drug: Docetaxel

Concurrent Therapy

Active Comparator group

Description:

Docetaxel will be given at 50mg/m\^2 Intravenous Day1 concomitantly with capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).

Treatment:

Drug: Capecitabine

Drug: Docetaxel