Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00814567
Protocol/serial number
CCR2690
Study information
Scientific title
Randomised trial testing Intensity Modulated radiotherapy and Partial Organ RadioTherapy following breast conservation surgery for early breast cancer
Acronym
IMPORT LOW
Study hypothesis
To test partial breast radiotherapy delivered using intensity modulated techniques following complete local tumour excision of low risk early stage breast cancer.
A related study IMPORT HIGH is registered with ISRCTN47437448.
Ethics approval
Oxford Research Ethics Committee B, 12/10/2006, ref: 06/Q1605/128
Study design
Prospective randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Breast cancer
Intervention
This is a randomised controlled trial for patients at low risk of local recurrence (less than 1% annual risk local recurrence after radiotherapy).
Control group: current standard radiotherapy to the whole breast
Test arm one: reduced radiotherapy to the whole breast with standard radiotherapy to the partial breast
Test arm two: standard radiotherapy to the partial breast only
Intervention type
Other
Phase
Drug names
Primary outcome measure
Local tumour control in the ipsilateral breast
Secondary outcome measures
1. Location of tumour relapse
2. Contralateral primary tumours
3. Regional and distant metastases
4. Late adverse effects in normal tissues
5. Quality of life (QL)
6. Economic evaluation
Overall trial start date
01/03/2007
Overall trial end date
01/10/2020
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current inclusion criteria as of 26/02/2019:
1. Age greater than or equal to 50 years
2. Primary breast conservation surgery +/- adjuvant systemic therapy
3. Pathological tumour size 3.0 cm pT1-2 (< 3.1 cm, maximum microscopic diameter of invasive component)
4. Invasive adenocarcinoma (excluding invasive carcinoma of classical lobular type)
5. Unifocal disease
6. Grade I, II or III
7. Lymphovascular invasion present or absent
8. Axillary lymph nodes negative or 1 to 3 nodes positive (pN0 or pN+(1-3))
9. Minimum microscopic margin of non-cancerous tissue 2 mm (excluding deep margin if this is at deep fascia)
10. No blood-borne metastases
Previous inclusion criteria:
1. Age greater than or equal to 50 years
2. Primary breast conservation surgery +/- adjuvant systemic therapy
3. Pathological tumour size less than or equal to 2.0 cm pT1a-c (maximum microscopic diameter of invasive component)
4. Invasive adenocarcinoma (excluding invasive carcinoma of classical lobular type)
5. Unifocal disease (Grade I or II)
6. Minimum microscopic margin of non-cancerous tissue greater than or equal to 2 mm (excluding deep margin if this is at deep fascia)
7. No lympho-vascular invasion
8. Axillary lymph nodes negative, PN0 (sentinel node biopsy & isolated tumour cells less than 0.2 mm allowed)
9. No blood borne metastases
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
1,935
Total final enrolment
2018
Participant exclusion criteria
Current exclusion criteria as of 26/02/2019:
1. Previous malignancy (other than non-melanomatous skin cancer)
2. Mastectomy
3. Invasive carcinoma of classical lobular type
4. Primary endocrine therapy or chemotherapy (neo-adjuvant endocrine therapy is permissible as long as the tumour is <3.0 cm and all other inclusion criteria are met. Primary endocrine therapy as a replacement for surgery is not permissible)
5. Concurrent chemo-radiotherapy
Previous exclusion criteria:
1. Previous malignancy (other than non-melanomatous skin cancer)
2. Mastectomy
3. Invasive carcinoma of classical lobular type
4. Primary endocrine therapy or chemotherapy (neo-adjuvant endocrine therapy is permissible as long as the tumour is less than 2.0 cm and all other inclusion criteria are met. Primary endocrine therapy as a replacement for surgery is not permissible)
5. Concurrent chemo-radiotherapy
Recruitment start date
01/03/2007
Recruitment end date
05/10/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Institute of Cancer Research
Sutton
SM2 5PT
United Kingdom
Sponsor information
Organisation
Institute of Cancer Research (UK)
Sponsor details
123 Old Brompton Road
London
SW7 3RP
United Kingdom
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK (UK)
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Funder name
Department of Health (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28779963
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30532984 (added 20/12/2019)