Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer
Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant, Dose-Dense Docetaxel/Capecitabine as in Induction Therapy for Early Stage Breast Cancer
1 other identifier
interventional
51
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Aug 2006
Typical duration for phase_2 breast-cancer
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2005
CompletedFirst Posted
Study publicly available on registry
September 21, 2005
CompletedStudy Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedResults Posted
Study results publicly available
June 25, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedMarch 27, 2015
March 1, 2015
2.9 years
September 14, 2005
March 15, 2012
March 6, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 year
Secondary Outcomes (1)
Long Term Follow up Data on Recurrence and Survival
2 years
Study Arms (2)
Sequential Therapy
ACTIVE COMPARATORDocetaxel 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
ACTIVE COMPARATORDocetaxel 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).
Interventions
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.
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 Criteria
You may qualify if:
- 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.
- years of age or older.
- Final eligibility for a clinical trial is determined by the health professionals conducting the trial.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
- Georgia Center for Oncology Research & Educationcollaborator
- Sanoficollaborator
Study Sites (19)
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
Emory Crawford Long Hospital
Atlanta, Georgia, 30308, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322, United States
Augusta Oncology Associates, PC 1348 Walton Way, Ste. 4300
Augusta, Georgia, 30901, United States
Augusta Oncology Associates, PC 3696 Wheeler Road
Augusta, Georgia, 30909, United States
WellStar Health System-Georgia Cancer Specialists
Austell, Georgia, 30106, United States
WellStar Health System-Northwest Georgia Oncology Center, PC
Austell, Georgia, 30106, United States
WellStar Health System-Northwest Georgia Oncology Center, PC
Carrollton, Georgia, 30117, United States
John B. Amos Cancer Center
Columbus, Georgia, 31904, United States
Suburban Hematology-Oncology Associates, PC
Duluth, Georgia, 30096, United States
South Atlanta Hematology-Oncology Group
East Point, Georgia, 30344, United States
Suburban Hematology-Oncology Associates, PC
Lawrenceville, Georgia, 30045, United States
Central Georgia Cancer Care, PC
Macon, Georgia, 31201, United States
WellStar Health System-Georgia Cancer Specialists
Marietta, Georgia, 30060, United States
WellStar Health System-Northwest Georgia Oncology Center, PC
Marietta, Georgia, 30060, United States
South Atlanta Hematology-Oncology Group
Riverdale, Georgia, 30274, United States
Suburban Hematology-Oncology Associates, PC
Snellville, Georgia, 30078, United States
South Atlanta Hematology-Oncology Group
Stockbridge, Georgia, 30281, United States
Central Georgia Cancer Care, PC
Warner Robins, Georgia, 31093, United States
Related Publications (2)
Zelnak AB, Styblo TM, Rizzo M, Gabram SG, Wood WC, Harichand-Herdt S, Kim S, Liu Y, O'Regan RM; Georgia Center for Oncology Research and Education. Final results from phase II trial of neoadjuvant docetaxel and capecitabine given sequentially or concurrently for HER2-negative breast cancers. Clin Breast Cancer. 2013 Jun;13(3):173-9. doi: 10.1016/j.clbc.2012.12.004. Epub 2013 Jan 16.
PMID: 23332349RESULTHoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.
PMID: 34037241DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Amelia Zelnak
- Organization
- Emory University
Study Officials
- PRINCIPAL INVESTIGATOR
Amelia Zelnak, MD
Emory University Winship Cancer Institute
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
September 14, 2005
First Posted
September 21, 2005
Study Start
August 1, 2006
Primary Completion
July 1, 2009
Study Completion
October 1, 2012
Last Updated
March 27, 2015
Results First Posted
June 25, 2012
Record last verified: 2015-03