Radiation dose intensity study in breast cancer in young women: a randomised phase III trial of additional dose to the tumour bed

Phase 3

Completed

• Conditions: Breast cancer; Cancer

• Registration Number: ISRCTN45066831
• Lead Sponsor: Commission for Clinical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (The Netherlands)

Brief Summary

2015 results presented at 3rd ESTRO Forum 2015: https://www.researchgate.net/publication/281211644_OC-0389_The_influence_of_the_boost_dose_on_cosmetic_outcome_after_breast_conserving_therapy_results_of_the_Young_Boost_Trial [added 14/02/2019] 2018 results presented at Clinical Science Symposium: https://www.ejcancer.com/article/S0959-8049(18)30267-3/pdf [added 14/02/2019]

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-12-20
• Study Completion: 2009-07-01
• Last Update Posted: 11 March 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1160

Inclusion Criteria

1. Age 50 years or younger
2. Histological diagnosis of invasive mammary cancer including all subtypes of invasive adenocarcinoma
3. Tumour location and extension imaged prior to surgery using at least mammography and ultrasound
4. Unicentric tumours and multifocal tumours removed using a wide local excision; microscopic radical resection (focally involved margins allowed, defined as: any Ductal Carcinoma In Situ [DCIS] or invasive carcinoma in three 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 less than 10 weeks before the start of radiotherapy
9. In cases where adjuvant chemotherapy is given immediately after surgery, wide local excision has been performed less than 6 months before the start of radiotherapy, and chemotherapy should be completed less than 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 tumour 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. Eastern Cooperative Oncology Group (ECOG) performance scale 2 or less

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 tumour
4. Concurrent pregnancy
5. Multicentric tumours, and multifocal tumours excised using multiple excisions
6. Invasive breast cancer in both breasts

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ocal control at 10 years.

Secondary Outcome Measures

Name	Time	Method
<br> 1. Cosmetic outcome<br> 2. Additional objective is to test the genotypic and phenotypic profiles of breast tumours in young patients with invasive breast cancer, and its relation to:<br> 2.1. Local recurrence after Breast Conserving Therapy (BCT)<br> 2.2. Lymph node metastases<br> 2.3. Distant metastases and survival<br> 2.4. Radio sensitivity<br> 2.5. Age<br> 3. To determine whether improved genotypic and phenotypic profiles can be determined related to the endpoints mentioned in A<br>