Radiation Therapy in Treating Women With Invasive Breast Cancer

NCT00301041 | Completed Early Phase 1

• 1 other identifier: CDR0000465214
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. PURPOSE: This randomized clinical trial is studying the side effects and best way to give radiation therapy and to see how well it works in treating patients with invasive breast cancer.

Conditions

Breast Cancer

Keywords

invasive ductal breast carcinoma; invasive lobular breast carcinoma; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer

Interventions

laboratory biomarker analysis OTHER

adjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed invasive breast cancer * Underwent lumpectomy (breast-preserving surgery) with or without adjuvant chemotherapy within the past 12 weeks * Histologically negative surgical margins (i.e., no tumor on ink) * Candidates for postoperative breast radiotherapy * Determined not to need radiotherapy to regional nodes (e.g., third supraclavicular field) * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No history of scleroderma or systemic lupus erythematosis * No other prior or concurrent malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior breast radiotherapy

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCSF Helen Diller Family Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Ductal, Breast; Carcinoma, Lobular

Interventions

Chemotherapy, Adjuvant; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Catherine C. Park, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2006
• First Posted: March 10, 2006
• Study Start: April 1, 2004
• Primary Completion: May 1, 2004
• Study Completion: May 1, 2004
• Last Updated: August 21, 2013

Record last verified: 2013-08

Locations

US (1)