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

A Pilot Safety And Feasibility Study Of Concurrent Capecitabine (Xeloda) And External Beam Irradiation In The Adjuvant Treatment Of High Risk Early Stage Breast Cancer.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00562718
Enrollment
50
Registered
2007-11-22
Start date
2004-09-30
Completion date
2009-11-30
Last updated
2020-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, male breast cancer, recurrent breast cancer

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.

Interventions

DRUGcapecitabine
PROCEDUREadjuvant therapy
RADIATIONradiation therapy

Sponsors

University of Texas Southwestern Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed invasive adenocarcinoma of the breast, meeting 1 of the following high-risk criteria: * T3 or T4 primary tumor * 4 or more involved axillary lymph nodes (N2 nodal stage) * Completed surgical excision * No immediate reconstruction with autologous flap reconstruction * Patients having tissue expanders or implants placed prior to radiation may be enrolled at the physician's discretion * No residual breast cancer * Microscopically positive margins are allowed if a re-excision is not felt to be clinically justified * Candidate for radiotherapy * Must not require bilateral radiotherapy * No metastatic (stage IV) breast cancer by AJCC staging criteria * Hormone receptor status not specified * No CNS disorders PATIENT CHARACTERISTICS: * Life expectancy ≥ 6 months * Karnofsky performance status 70-100% * Menopausal status not specified * Ambulatory * Hemoglobin \> 9 g/dL * Platelet count \> 100,000/mm³ * ANC \> 1,500/mm³ * Serum AST, ALT, and alkaline phosphatase ≤ 2 times upper limit of normal (ULN) * Total bilirubin normal * Creatinine clearance \> 50 mL/min * Negative pregnancy test * Not pregnant or nursing * Fertile patients must use effective contraception during study and for 30 days after the last study drug administration * No serious, uncontrolled, concurrent infection(s) * No diabetes with current or history of delayed wound healing or skin ulcers * No autoimmune connective tissue disorder * No prior unanticipated severe reaction to fluoropyrimidine therapy, known sensitivity to 5-fluorouracil, or known dihydropyrimidine dehydrogenase (DPD) deficiency * No other carcinomas within the last five years except cured non-melanoma skin cancer and in-situ cervical cancer * No clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 12 months * No other serious uncontrolled medical conditions that the investigator feels might compromise study participation, including any of the following: * Uncontrolled seizures * Psychiatric disability judged by the investigator to be clinically significant * Physically intact upper gastrointestinal tract * No malabsorption syndrome * No uncompensated coagulopathy * No patients whose breast size or body contour puts them at increased risk for skin desquamation from standard radiotherapy * Able to read and speak English PRIOR CONCURRENT THERAPY: * Fully recovered from surgery and chemotherapy with completely healed surgical wounds * At least 4 weeks since completion of prior chemotherapy regimen, excluding trastuzumab (Herceptin®) * Concurrent trastuzumab allowed at the physician's discretion * More than 4 weeks since prior participation in any investigational drug study * At least 4 weeks since prior and no concurrent sorivudine or brivudine * More than 2 weeks since prior major surgery * No prior capecitabine * No prior radiotherapy to the chest or ipsilateral lymphatics * No concurrent hormonal therapy during course of chemotherapy or radiation therapy * No concurrent allopurinol or cimetidine * Concurrent coumadin is allowed

Design outcomes

Primary

MeasureTime frameDescription
Overall Safety1 yearPrimarily Grade 1 and 2 toxicities attributable to capecitabine

Secondary

MeasureTime frameDescription
Cosmesis1 year
Recurrence1 yearThis population has aggressive disease with a high rate of recurrence and death within 1 year of completing radiation therapy

Countries

United States

Participant flow

Participants by arm

ArmCount
Surgery and Chemotherapy
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. capecitabine adjuvant therapy radiation therapy
39
Total39

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event4
Overall StudyDeath1
Overall StudyLack of Efficacy2
Overall Studynot stated1
Overall StudyWithdrawal by Subject3

Baseline characteristics

CharacteristicSurgery and Chemotherapy
adjuvant28 Participants
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
39 Participants
Age, Continuous52 years
masectomy6 Participants
neo-adjuvant14 Participants
partial masectomy22 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
2 Participants
Race (NIH/OMB)
Black or African American
12 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
23 Participants
Region of Enrollment
United States
39 Participants
Sex: Female, Male
Female
39 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
6 / 39
other
Total, other adverse events
8 / 39
serious
Total, serious adverse events
6 / 39

Outcome results

Primary

Overall Safety

Primarily Grade 1 and 2 toxicities attributable to capecitabine

Time frame: 1 year

Population: Radiation given based on planned- 50.4cGy

ArmMeasureValue (NUMBER)
Surgery and ChemotherapyOverall Safety12.6 percentage of participants
Secondary

Cosmesis

Time frame: 1 year

ArmMeasureValue (NUMBER)
Surgery and ChemotherapyCosmesis22 participants
Secondary

Recurrence

This population has aggressive disease with a high rate of recurrence and death within 1 year of completing radiation therapy

Time frame: 1 year

ArmMeasureValue (NUMBER)
Surgery and ChemotherapyRecurrence14 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026