Capecitabine and Radiation Therapy in Treating Patients With Nonmetastatic Breast Cancer After Surgery

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: capecitabine; Procedure: adjuvant therapy; Radiation: radiation therapy

• Registration Number: NCT00562718
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high energy x-rays to kill tumor cells. Capecitabine may also make tumor cells more sensitive to radiation therapy. Giving radiation together with capecitabine after surgery may kill any remaining tumor cells.

PURPOSE: This phase II trial is studying the side effects and how well giving capecitabine together with radiation therapy works in treating patients with nonmetastatic breast cancer.

Detailed Description

OBJECTIVES:

Primary

* To determine the safety and feasibility of concurrent capecitabine and standard external-beam irradiation in patients with high-risk early stage breast cancer.

Secondary

* To determine the effects of concurrent treatment on cosmesis and wound healing at 1 year.

* To determine the short-term (1-year) risk of recurrence of breast cancer in these patients.

OUTLINE: This is a multicenter study.

Patients undergo external-beam radiotherapy once daily, 5 days a week and concurrently receive oral capecitabine twice daily, 5 days a week Monday through Friday, for approximately 6-7 weeks.

After completion of study therapy, patients are followed at approximately 1 week, 1 month, 6 months, and 12 months.

Study Timeline

• Study Start: 2004-09
• Study First Submitted: 2007-11-21
• Study First Submitted QC: 2007-11-21
• Study First Posted: 2007-11-22
• Primary Completion: 2009-09
• Study Completion: 2009-11
• Status Verified: 2019-04
• Results First Submitted: 2019-05-16
• Results First Submitted QC: 2019-07-18
• Results First Posted: 2019-07-23
• Last Update Submitted: 2020-08-19
• Last Update Posted: 2020-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery and Chemotherapy	adjuvant therapy	Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.
Surgery and Chemotherapy	radiation therapy	Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.
Surgery and Chemotherapy	capecitabine	Eligible patients had undergone surgery and chemotherapy for high risk breast cancer, defined as either a T3 or T4 primary tumor, or N2 by either clinical or pathological criteria.

Primary Outcome Measures

Name	Time	Method
Overall Safety	1 year	Primarily Grade 1 and 2 toxicities attributable to capecitabine

Secondary Outcome Measures

Name	Time	Method
Cosmesis	1 year
Recurrence	1 year	This population has aggressive disease with a high rate of recurrence and death within 1 year of completing radiation therapy

Trial Locations

Locations (1)

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas; 🇺🇸 Dallas, Texas, United States