Breast Cancer
Conditions
Keywords
recurrent breast cancer, stage IA breast cancer, stage II breast cancer, invasive ductal breast carcinoma, invasive ductal breast carcinoma with predominant intraductal component
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.
Interventions
RADIATIONradiation therapy
Patients undergo standard whole breast, reduced whole breast, or standard partial breast radiotherapy
Sponsors
Cancer Research UK
Institute of Cancer Research, United Kingdom
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of low-risk early stage breast cancer, meeting the following criteria: * Invasive adenocarcinoma * No invasive carcinoma of classical lobular type * lympho-vascular invasion present or absent * 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 or 1-3 nodes positive (pN0 or pN+(1-3)) * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local tumor control in the ipsilateral breast (i.e., true recurrence plus new primary tumor) as confirmed by cytological or histological assessment | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Contralateral primary breast cancer or other primary tumors as confirmed by cytological or histological assessment | 5 years |
| Regional and distant metastases | 5 years |
| Location of tumor relapse | 5 years |
| 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 | 5 years |
| Cost-effectiveness as assessed by EQ-5D questionnaire at baseline, 6 months, and 1, 2, and 5 years | 10 years |
| Late adverse effects in normal tissue normal tissues as determined periodically by photographic assessments (in a subset of patients), physician assessments, and patient self-assessments | 5 years |
Countries
United Kingdom
Outcome results
None listed