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Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer

This study has been terminated.
Sponsor:
Collaborators:
Georgia Center for Oncology Research & Education
Sanofi
Information provided by (Responsible Party):
Amelia Zelnak, Emory University
ClinicalTrials.gov Identifier:
NCT00209092
First received: September 14, 2005
Last updated: June 20, 2012
Last verified: June 2012
History of Changes

September 14, 2005
June 20, 2012
August 2006
July 2009   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00209092 on ClinicalTrials.gov Archive Site
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
Not Provided
Not Provided
Not Provided
 
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.

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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • 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: 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).
    Interventions:
    • Drug: Docetaxel
    • Drug: Capecitabine
  • 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).
    Interventions:
    • Drug: Docetaxel
    • Drug: Capecitabine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
51
September 2012
July 2009   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00209092
1114-2003
Yes
Amelia Zelnak, Emory University
Emory University
  • Georgia Center for Oncology Research & Education
  • Sanofi
Principal Investigator: Ruth Regan, MD Emory University Winship Cancer Institute
Emory University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP