Breast cancer
Conditions
Interventions
All patients will be treated with breast conserving therapy, followed by 50 Gy to the whole breast.
Patients will be randomized to receive a boost dose of 16 Gy or 26 Gy to the tumorbed.
Sponsors
Prof. dr H. Bartelink, AvL/NKI, Plesmanlaan 121, 1069 CX Amsterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age 50 years or younger; 2. Histological diagnosis of invasive mammary cancer including all subtypes of invasive adenocarcinoma; 3. Tumor location and extension imaged prior to surgery using at least mammography and ultrasound; 4. Unicentric tumors and multifocal tumors removed using a wide local excision; microscopic radical resection (focally involved margins allowed, defined as: any DCIS or invasive carcinoma in 3 or fewer low-power fields (using a x 4 objective and a x 10 ocular lens, which has a diameter of 5 mm per low-power microscopic fields); 5. Sentinel lymph node biopsy and/or axillary lymph node dissection has been performed; 6. Breast cancer stage: pT1-2pN0-2a M0; 7. No treatment is allowed prior to surgery (no neoadjuvant chemotherapy, no neoadjuvant hormonal therapy, no pre-operative radiotherapy); 8. In cases where no adjuvant chemotherapy is given, wide local excision has been performed < 10 weeks before the start of radiotherapy; 9. In cases where adjuvant chemotherapy is given immediately after surgery, wide local excision has been performed < 6 months before the start of radiotherapy, and chemotherapy should be completed < 6 weeks before the start of radiotherapy; 10. In cases where hormonal treatment is planned, this is given after completion of the radiotherapy; 11. No previous history or synchronous malignant tumor in the other breast, previous history of malignant disease, except adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin; 12. ECOG performance scale 2 or less.
Exclusion criteria
Exclusion criteria: 1. Residual microcalcifications on mammogram; 2. All histological types of malignancies other than invasive adenocarcinoma; 3. In situ carcinoma of the breast, without invasive tumor; 4. Concurrent pregnancy; 5. Multicentric tumors, and multifocal. tumors excised using multiple excisions; 6. Invasive breast cancer in both breasts.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Local control at 10 yr. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cosmetic outcome. Additional objectives: A. To test the genotypic and phenotypic profiles of breast tumors [van de Vijver et al.,2002] in young patients with invasive breast cancer, and its relation to: a. Local recurrence after BCT; b. Lymph node metastases; c. Distant metastases and surviva; d. Radiosensitivity; e. Age; B. To determine whether improved genotypic and phenotypic profiles can be determined related to the endpoints mentioned in A. | — |
Contacts
Public ContactH. Bartelink
Nederlands Kanker Instituut/ Antoni van Leeuwenhoek hospital, Plesmanlaan 121
Outcome results
None listed