Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Docetaxel; Drug: Capecitabine

• Registration Number: NCT00209092
• Lead Sponsor: Emory University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2005-09-14
• Study First Submitted QC: 2005-09-14
• Study First Posted: 2005-09-21
• Study Start: 2006-08
• Primary Completion: 2009-07
• Results First Submitted: 2012-03-15
• Results First Submitted QC: 2012-06-20
• Results First Posted: 2012-06-25
• Study Completion: 2012-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-06
• Last Update Posted: 2015-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 51

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sequential Therapy	Docetaxel	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).
Sequential Therapy	Capecitabine	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).
Concurrent Therapy	Docetaxel	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).
Concurrent Therapy	Capecitabine	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).

Primary Outcome Measures

Name	Time	Method
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.	1 year	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.

Secondary Outcome Measures

Name	Time	Method
Long Term Follow up Data on Recurrence and Survival	2 years	Number of Patients remained alive and relapse free

Trial Locations

Locations (11)

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States

Augusta Oncology Associates, PC 3696 Wheeler Road; 🇺🇸 Augusta, Georgia, United States

Emory Crawford Long Hospital; 🇺🇸 Atlanta, Georgia, United States

Augusta Oncology Associates, PC 1348 Walton Way, Ste. 4300; 🇺🇸 Augusta, Georgia, United States

Emory University Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States

John B. Amos Cancer Center; 🇺🇸 Columbus, Georgia, United States

Suburban Hematology-Oncology Associates, PC; 🇺🇸 Snellville, Georgia, United States

South Atlanta Hematology-Oncology Group; 🇺🇸 Stockbridge, Georgia, United States

Central Georgia Cancer Care, PC; 🇺🇸 Warner Robins, Georgia, United States

WellStar Health System-Georgia Cancer Specialists; 🇺🇸 Marietta, Georgia, United States

WellStar Health System-Northwest Georgia Oncology Center, PC; 🇺🇸 Marietta, Georgia, United States