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

ISRCTN	ISRCTN45066831
DOI	https://doi.org/10.1186/ISRCTN45066831
ClinicalTrials.gov (NCT)	NCT00212121
Protocol serial number	1
Sponsor	Commission for Clinical Applied Research (Commissie voor Klinisch Toegepast Onderzoek [CKTO]) (The Netherlands)
Funder	Commission for Clinical Applied Research (Commissie voor Klinisch Toegepast Onderzoek - CKTO) (The Netherlands)

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 14/02/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof H. Bartelink
Scientific

Nederlands Kanker Instituut/ Antoni van Leeuwenhoek Ziekenhuis, Plesmanlaan 121
Amsterdam
1166 CX
Netherlands

Phone	+31(0)20 512 2120/1731
Email	h.bartelink@nki.nl

Study information

Primary study design	Interventional
Study design	Randomised active-controlled phase III trial
Secondary study design	Randomised controlled trial
Scientific title	Radiation dose intensity study in breast cancer in young women: a randomised phase III trial of additional dose to the tumour bed
Study acronym	Young Boost Trial
Study objectives	10 Gy additional boost to the tumour bed will yield an increase in local control at 10 years from 88% to 93%, with still acceptable cosmesis.
Ethics approval(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	Breast cancer
Intervention	All patients will be treated with breast conserving therapy, followed by 50 Gy to the whole breast. Patients will be randomised to receive a boost dose of 16 Gy or 26 Gy to the tumour bed.
Intervention type	Other
Primary outcome measure(s)	Local control at 10 years.
Key secondary outcome measure(s)	1. Cosmetic outcome 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: 2.1. Local recurrence after Breast Conserving Therapy (BCT) 2.2. Lymph node metastases 2.3. Distant metastases and survival 2.4. Radio sensitivity 2.5. Age 3. To determine whether improved genotypic and phenotypic profiles can be determined related to the endpoints mentioned in A
Completion date	01/07/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target sample size at registration	1160
Key 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
Key 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
Date of first enrolment	01/07/2004
Date of final enrolment	01/07/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Nederlands Kanker Instituut/ Antoni van Leeuwenhoek Ziekenhuis, Plesmanlaan 121

Amsterdam
1166 CX
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results	results presented at 3rd ESTRO Forum :	01/04/2015	14/02/2019	No	No
Abstract results	results presented at Clinical Science Symposium:	01/04/2018	14/02/2019	No	No
Study website	Study website	11/11/2025	11/11/2025	No	Yes

Editorial Notes

14/02/2019: Publication references added.