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

NCT00562718 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: CDR0000574761SCCC-072004-004ROCHE-SCCC-072004-004
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall Safety

  Primarily Grade 1 and 2 toxicities attributable to capecitabine

  1 year

Secondary Outcomes (2)

• Cosmesis

  1 year

• Recurrence

  1 year

Study Arms (1)

Surgery and Chemotherapy

EXPERIMENTAL

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.

Drug: capecitabine; Procedure: adjuvant therapy; Radiation: radiation therapy

Interventions

capecitabine DRUG

Surgery and Chemotherapy

adjuvant therapy PROCEDURE

Surgery and Chemotherapy

radiation therapy RADIATION

Surgery and Chemotherapy

Eligibility Criteria

• Age: 18 Years - 120 Years
• Gender Eligibility Details: Female only study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Capecitabine; Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Combined Modality Therapy; Therapeutics; Drug Therapy

Results Point of Contact

• Title: ann spangler
• Organization: UT Southwestern Medical Center

ResearchRegistry@utsouthwestern.edu

(214) 648-3111

Study Officials

• Dan P. Garwood, MD

  Simmons Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2007
• First Posted: November 22, 2007
• Study Start: September 1, 2004
• Primary Completion: September 1, 2009
• Study Completion: November 1, 2009
• Last Updated: August 21, 2020
• Results First Posted: July 23, 2019

Record last verified: 2019-04

Locations

US (1)