Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer - Full Text View

Purpose

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.

Condition	Intervention	Phase
Breast Cancer	Drug: Docetaxel Drug: Capecitabine	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docetaxel Capecitabine

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:

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 Plus Capecitabine for 8 Cycles)in Patients With Early Stage Breast Cancer. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Pathologic complete response (pCR): Absence of invasive breast cancer in the breast.

Overall Clinical Response=Complete response(CR-complete disappearance of all measurable malignanat disease)+partial response(PR-reduction by atleast 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:

Long Term Follow up Data on Recurrence and Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Number of Patients remained alive and relapse free

Enrollment:	51
Study Start Date:	August 2006
Estimated Study Completion Date:	September 2012
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 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).	Drug: 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. Drug: 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).
Active Comparator: 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).	Drug: 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. Drug: 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).

Arms

Assigned Interventions

Active Comparator: 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).

Drug: 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.

Drug: 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).

Active Comparator: 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).

Drug: 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.

Drug: 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).

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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 CNS metastases.
Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00209092

Locations

United States, Georgia
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Emory Crawford Long Hospital
Atlanta, Georgia, United States, 30308
Grady Memorial Hospital
Atlanta, Georgia, United States, 30303
Augusta Oncology Associates, PC 1348 Walton Way, Ste. 4300
Augusta, Georgia, United States, 30901
Augusta Oncology Associates, PC 3696 Wheeler Road
Augusta, Georgia, United States, 30909
WellStar Health System-Northwest Georgia Oncology Center, PC
Austell, Georgia, United States, 30106
WellStar Health System-Georgia Cancer Specialists
Austell, Georgia, United States, 30106
WellStar Health System-Northwest Georgia Oncology Center, PC
Carrollton, Georgia, United States, 30117
John B. Amos Cancer Center
Columbus, Georgia, United States, 31904
Suburban Hematology-Oncology Associates, PC
Duluth, Georgia, United States, 30096
South Atlanta Hematology-Oncology Group
East Point, Georgia, United States, 30344
Suburban Hematology-Oncology Associates, PC
Lawrenceville, Georgia, United States, 30045
Central Georgia Cancer Care, PC
Macon, Georgia, United States, 31201
WellStar Health System-Northwest Georgia Oncology Center, PC
Marietta, Georgia, United States, 30060
WellStar Health System-Georgia Cancer Specialists
Marietta, Georgia, United States, 30060
South Atlanta Hematology-Oncology Group
Riverdale, Georgia, United States, 30274
Suburban Hematology-Oncology Associates, PC
Snellville, Georgia, United States, 30078
South Atlanta Hematology-Oncology Group
Stockbridge, Georgia, United States, 30281
Central Georgia Cancer Care, PC
Warner Robins, Georgia, United States, 31093

Sponsors and Collaborators

Emory University

Georgia Center for Oncology Research & Education

Sanofi

Investigators

Principal Investigator:

Ruth Regan, MD

Emory University Winship Cancer Institute

More Information

No publications provided

Responsible Party:	Amelia Zelnak, MD, Emory University
ClinicalTrials.gov Identifier:	NCT00209092 History of Changes
Other Study ID Numbers:	1114-2003
Study First Received:	September 14, 2005
Results First Received:	March 15, 2012
Last Updated:	June 20, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

Breast Cancer

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Capecitabine
Fluorouracil
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013