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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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 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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Ruth Regan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

1114-2003

NCT ID:

NCT00209092

Start Date:

August 2006

Completion Date:

September 2012

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Breast Neoplasms

Name

Location

Grady Memorial HospitalAtlanta, Georgia  30335
John B. Amos Cancer CenterColumbus, Georgia  31904
Emory Crawford Long HospitalAtlanta, Georgia  30308
Emory University Winship Cancer InstituteAtlanta, Georgia  30322
Suburban Hematology-Oncology Associates, PcLawrenceville, Georgia  30046
Augusta Oncology Associates, PC 1348 Walton Way, Ste. 4300Augusta, Georgia  30901
Augusta Oncology Associates, PC 3696 Wheeler RoadAugusta, Georgia  30909
WellStar Health System-Northwest Georgia Oncology Center, PCAustell, Georgia  30106
WellStar Health System-Georgia Cancer SpecialistsAustell, Georgia  30106
South Atlanta Hematology-Oncology GroupEast Point, Georgia  30344
Central Georgia Cancer Care, PCMacon, Georgia  31201