Radiation Therapy in Treating Women With Early-Stage Breast Cancer Who Have Undergone Breast Conservation Surgery

Tracking Information
First Submitted Date ICMJE	December 24, 2008
First Posted Date ICMJE	December 25, 2008
Last Update Posted Date	January 7, 2011
Study Start Date ICMJE	October 2006
Estimated Primary Completion Date	June 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 24, 2008)	Local tumor control in the ipsilateral breast (i.e., true recurrence plus new primary tumor) as confirmed by cytological or histological assessment
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00814567 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: December 24, 2008)	Location of tumor relapse; Contralateral primary breast cancer or other primary tumors as confirmed by cytological or histological assessment; Regional and distant metastases; Late adverse effects in normal tissues as determined periodically by photographic assessments (in a subset of patients), physician assessments, and patient self-assessments; Quality of life as assessed by EORTC QLQ C-30, EORTC QLQ-BR23, BIS, and HADS questionnaires in a subset of patients at baseline, 6 months, and 1, 2, and 5 years; Cost-effectiveness as assessed by EQ-5D questionnaire at baseline, 6 months, and 1, 2, and 5 years
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Radiation Therapy in Treating Women With Early-Stage Breast Cancer Who Have Undergone Breast Conservation Surgery
Official Title ICMJE	Randomised Trial Testing Intensity Modulated and Partial Organ Radiotherapy After Breast Conservation Surgery for Early Breast Cancer
Brief Summary	RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. It is not yet known whether intensity-modulated radiation therapy is more effective than standard radiation therapy in treating patients with early-stage breast cancer. PURPOSE: This randomized phase III trial is comparing radiation therapy regimens in treating women with early-stage breast cancer who have undergone breast-conservation surgery.
Detailed Description	OBJECTIVES: To test partial breast radiotherapy using intensity-modulated techniques following complete local tumor excision in women with low-risk, early stage breast cancer. OUTLINE: This is a multicenter study. Patients are stratified according to center (not participating in sub-studies vs participating in sub-studies). Patients are randomized to 1 of 3 treatment arms.; Arm I (control): Patients undergo standard whole breast radiotherapy once daily on days 1-5 (15 fractions) for 3 weeks.; Arm II: Patients undergo reduced whole breast radiotherapy (15 fractions) and standard partial breast radiotherapy (15 fractions) once daily on days 1-5 for 3 weeks.; Arm III: Patients undergo standard partial breast radiotherapy once daily on days 1-5 (15 fractions) for 3 weeks. All patients complete a family history questionnaire at baseline. Patients also undergo blood sample collection at baseline and paraffin-embedded tissue collection at follow-up for molecular studies analyzing inter-patient variation by microarrays. Patients in centers participating in sub-studies undergo quality of life and health economic assessment at baseline, 6 months, and 1, 2, and 5 years. These patients also undergo photographic assessment at baseline, 2 years, and 5 years. After completion of study treatment, patients are followed for 10 years.
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Primary Purpose: Treatment
Condition ICMJE	Breast Cancer
Intervention ICMJE	Radiation: radiation therapy; Patients undergo standard whole breast, reduced whole breast, or standard partial breast radiotherapy
Study Arms	Active Comparator: Arm I (control) Patients undergo standard whole breast radiotherapy once daily on days 1-5 for 3 weeks. Intervention: Radiation: radiation therapy; Experimental: Arm II Patients undergo reduced whole breast radiotherapy and standard partial breast radiotherapy once daily on days 1-5 for 3 weeks. Intervention: Radiation: radiation therapy; Experimental: Arm III Patients undergo standard partial breast radiotherapy once daily on days 1-5 for 3 weeks. Intervention: Radiation: radiation therapy
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Unknown status
Estimated Enrollment ICMJE; (submitted: December 24, 2008)	1935
Original Estimated Enrollment ICMJE	Same as current
Study Completion Date	Not Provided
Estimated Primary Completion Date	June 2010 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	DISEASE CHARACTERISTICS: Diagnosis of low-risk early stage breast cancer, meeting the following criteria: Invasive adenocarcinoma No invasive carcinoma of classical lobular type No lymphovascular invasion Tumor size pathologically determined to be ≤ 3.0 cm in diameter (pT1-2) (< 3.1 cm maximum microscopic diameter of invasive component) Unifocal disease Grade I, II, or III disease Axillary lymph nodes negative (pN0) Sentinel lymph node biopsy and isolated tumor cells < 0.2 mm allowed; Must have undergone breast conservation surgery with or without adjuvant systemic therapy Minimum microscopic margin of non-cancerous tissue ≥ 2 mm (excluding deep margin if this is at deep fascia); At low risk of local recurrence after radiotherapy (< 1% annual risk local recurrence); No prior mastectomy; No blood-borne metastases PATIENT CHARACTERISTICS: No prior malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: See Disease Characteristics; No prior endocrine therapy or chemotherapy Neoadjuvant endocrine therapy allowed provided the tumour is < 3.0 cm and all other inclusion criteria are met No primary endocrine therapy as a replacement for surgery; No concurrent chemoradiotherapy
Sex/Gender	Sexes Eligible for Study: Female
Ages	50 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United Kingdom
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00814567
Other Study ID Numbers ICMJE	CDR0000629768; ICR-IMPORT-LOW; ICR-CTSU/2006/10001; ISRCTN12852634; EU-20896
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor ICMJE	Institute of Cancer Research, United Kingdom
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: John R. Yarnold, MD, FRCR Royal Marsden NHS Foundation Trust
PRS Account	National Cancer Institute (NCI)
Verification Date	December 2008
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP