Clinical trial NCT00209092: Randomized Phase II Trial Induction Therapy for Early Stage Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Georgia Center for Oncology Research & Education
name: Sanofi
First posted: 2005-09-21
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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 central nervous system (CNS) metastases.
* Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Primary outcomes:
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 + Capecitabine for 8 Cycles) in Patients With Early Stage Breast Cancer.
timeFrame: 1 year
Secondary outcomes:
measure: Long Term Follow up Data on Recurrence and Survival
timeFrame: 2 years
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory Crawford Long Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
city: Augusta
country: United States
facility: Augusta Oncology Associates, PC 1348 Walton Way, Ste. 4300
state: Georgia
city: Augusta
country: United States
facility: Augusta Oncology Associates, PC 3696 Wheeler Road
state: Georgia
city: Austell
country: United States
facility: WellStar Health System-Georgia Cancer Specialists
state: Georgia
city: Austell
country: United States
facility: WellStar Health System-Northwest Georgia Oncology Center, PC
state: Georgia
city: Carrollton
country: United States
facility: WellStar Health System-Northwest Georgia Oncology Center, PC
state: Georgia
city: Columbus
country: United States
facility: John B. Amos Cancer Center
state: Georgia
city: Duluth
country: United States
facility: Suburban Hematology-Oncology Associates, PC
state: Georgia
city: East Point
country: United States
facility: South Atlanta Hematology-Oncology Group
state: Georgia
city: Lawrenceville
country: United States
facility: Suburban Hematology-Oncology Associates, PC
state: Georgia
city: Macon
country: United States
facility: Central Georgia Cancer Care, PC
state: Georgia
city: Marietta
country: United States
facility: WellStar Health System-Georgia Cancer Specialists
state: Georgia
city: Marietta
country: United States
facility: WellStar Health System-Northwest Georgia Oncology Center, PC
state: Georgia
city: Riverdale
country: United States
facility: South Atlanta Hematology-Oncology Group
state: Georgia
city: Snellville
country: United States
facility: Suburban Hematology-Oncology Associates, PC
state: Georgia
city: Stockbridge
country: United States
facility: South Atlanta Hematology-Oncology Group
state: Georgia
city: Warner Robins
country: United States
facility: Central Georgia Cancer Care, PC
state: Georgia
Study officials:
affiliation: Emory University Winship Cancer Institute
name: Amelia Zelnak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.