Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer

Phase 2CompletedNCT00209092

Emory University51 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

DocetaxelDRUG

Sequential Therapy: Docetaxel will be given at 100 mg/m\^2 Intravenously (IV)Day 1 every 3 weeks for 4 cycles. Concurrent Therapy: Docetaxel will be given at 50 mg/m\^2 IV Day 1.

CapecitabineDRUG

Sequential Therapy: administration of capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-14 every 3 weeks for 4 cycles (total 8 cycles) Concurrent Therapy: capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (19)

Grady Memorial Hospital

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

Number of Participants With Complete Pathologic Response Rate to Pre-operative Treatment in Arm A (Docetaxel for 4 Cycles Followed by Capecitabine for 4 Cycles) or Arm B (Docetaxel + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer.

Pathologic complete response (pCR): Absence of invasive breast cancer in the breast. Overall Clinical Response=Complete response(CR-complete disappearance of all measurable malignant disease)+partial response(PR-reduction by at least 30%) Stable disease (SD): No decrease or \<25% increase in the sum of the products of the longest perpendicular diameters of all measurable lesions. Progressive disease (PD): A 20% or greater increase in a single lesion, OR reappearance of any lesion which has disappeared, OR clear worsening of any evaluable disease OR appearance of any new lesion/site.

Time frame: 1 year

Secondary Outcomes

Long Term Follow up Data on Recurrence and Survival

Number of Patients remained alive and relapse free

Time frame: 2 years

Data from ClinicalTrials.gov

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