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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Docetaxel; Drug: Capecitabine

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 Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Long Term Follow up Data on Recurrence and Survival	Number of Patients remained alive and relapse free	2 years

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: Sanofi; Georgia Center for Oncology Research & Education
• Investigators: Principal Investigator: Amelia Zelnak, MD, Emory University Winship Cancer Institute

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: September 14, 2005
• First Submitted That Met QC Criteria: September 14, 2005
• First Posted (Estimate): September 21, 2005

Study Record Updates

• Last Update Posted (Estimate): March 27, 2015
• Last Update Submitted That Met QC Criteria: March 6, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Breast Cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Docetaxel; Capecitabine
• Other Study ID Numbers: 1114-2003