Radiation Therapy in Treating Women With Localized Breast Cancer

Prospective Randomised Clinical Trial Testing 5.7 Gy and 6.0 Gy Fractions of Whole Breast Radiotherapy in Terms of Late Normal Tissue Responses and Tumour Control - FAST

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00107497

Acronym

FAST

Enrollment

917

Registered

2005-04-06

Start date

2004-10-05

Completion date

2017-03-09

Last updated

2019-02-27

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

Conditions

Breast Cancer

Keywords

stage I breast cancer, stage II breast cancer

Brief summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in different ways and giving it after surgery may kill any tumor cells that remain after surgery. PURPOSE: This randomized clinical trial is studying radiation therapy to see how well it works in treating women with localized breast cancer.

Detailed description

OBJECTIVES: * Compare late normal tissue effects of standard vs 2 different dose levels of hypofractionated adjuvant whole breast radiotherapy, in terms of changes in photographic breast appearance, in women with localized breast cancer who are at average or low risk of recurrence. * Compare tumor control in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 3 treatment arms. * Arm I (control): Patients undergo standard radiotherapy 5 days a week for 5 weeks. * Arm II: Patients undergo hypofractional radiotherapy once a week for 5 weeks. * Arm III: Patients undergo hypofractional radiotherapy (at a lower dose than arm II) once a week for 5 weeks. After completion of study treatment, patients are followed annually for 5-10 years. PROJECTED ACCRUAL: A total of 900 patients (300 per treatment arm) will be accrued for this study within 12 months.

Interventions

RADIATIONRadiation therapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

50 Years to 120 Years

Healthy volunteers

Inclusion criteria

DISEASE CHARACTERISTICS: * Diagnosis of invasive carcinoma of the breast * Localized disease * Pathological tumor size \< 3.0 cm in diameter * Axillary node negative * At average or low risk of local tumor recurrence * Must have undergone prior breast-preserving surgery * No prior mastectomy * Complete microscopic resection of tumor * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age * 50 and over Sex * Female Menopausal status * Not specified Performance status * Not specified Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior neoadjuvant or adjuvant cytotoxic chemotherapy Endocrine therapy * Not specified Radiotherapy * No concurrent lymphatic radiotherapy * No concurrent radiotherapy boost to the breast Surgery * See Disease Characteristics

Design outcomes

Primary

Measure	Time frame	Description
Change in photographic breast appearance	2 years post randomisation	Change in photographic breast appearance at 2 years post randomisation compared to a baseline pre-surgical photograph

Countries

United Kingdom

Outcome results

None listed

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