Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer
NCT ID: NCT00209092
Last Updated: 2015-03-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
51 participants
INTERVENTIONAL
2006-08-31
2012-10-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Sequential Therapy
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).
Docetaxel
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.
Capecitabine
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).
Concurrent Therapy
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).
Docetaxel
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.
Capecitabine
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).
Interventions
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Docetaxel
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.
Capecitabine
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
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Georgia Center for Oncology Research & Education
OTHER
Sanofi
INDUSTRY
Emory University
OTHER
Responsible Party
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Amelia Zelnak
MD
Principal Investigators
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Amelia Zelnak, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University Winship Cancer Institute
Locations
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Grady Memorial Hospital
Atlanta, Georgia, United States
Emory Crawford Long Hospital
Atlanta, Georgia, United States
Emory University Winship Cancer Institute
Atlanta, Georgia, United States
Augusta Oncology Associates, PC 1348 Walton Way, Ste. 4300
Augusta, Georgia, United States
Augusta Oncology Associates, PC 3696 Wheeler Road
Augusta, Georgia, United States
WellStar Health System-Georgia Cancer Specialists
Austell, Georgia, United States
WellStar Health System-Northwest Georgia Oncology Center, PC
Austell, Georgia, United States
WellStar Health System-Northwest Georgia Oncology Center, PC
Carrollton, Georgia, United States
John B. Amos Cancer Center
Columbus, Georgia, United States
Suburban Hematology-Oncology Associates, PC
Duluth, Georgia, United States
South Atlanta Hematology-Oncology Group
East Point, Georgia, United States
Suburban Hematology-Oncology Associates, PC
Lawrenceville, Georgia, United States
Central Georgia Cancer Care, PC
Macon, 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
South Atlanta Hematology-Oncology Group
Riverdale, 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
Countries
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References
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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.
Hoon 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.
Other Identifiers
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1114-2003
Identifier Type: -
Identifier Source: org_study_id
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