Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00209092
• Other study ID #: 1114-2003
• Status: Completed
• Phase: Phase 2
• First received: September 14, 2005
• Last updated: March 6, 2015
• Start date: August 2006
• Est. completion date: October 2012

Study information

• Verified date: March 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 2012
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	Emory Crawford Long Hospital	Atlanta	Georgia
United States	Emory University Winship Cancer Institute	Atlanta	Georgia
United States	Grady Memorial Hospital	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

Sponsors (3)

Lead Sponsor	Collaborator
Emory University	Georgia Center for Oncology Research & Education, Sanofi

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 concurren — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Long Term Follow up Data on Recurrence and Survival	Number of Patients remained alive and relapse free	2 years	No