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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05350722




Registration number
NCT05350722
Ethics application status
Date submitted
14/03/2022
Date registered
28/04/2022

Titles & IDs
Public title
Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients
Scientific title
Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients
Secondary ID [1] 0 0
NL77000.029.21
Universal Trial Number (UTN)
Trial acronym
ABLATIVE-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Single dose ablative radiotherapy

Experimental: Pre-operative single dose partial breast irradiation -


Treatment: Other: Single dose ablative radiotherapy
Patients will receive a single dose of 20Gy/15Gy on the gross tumor volume and clinical tumor volume respectively, in the context of pre-operative partial breast irradiation
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pathologic complete response
Timepoint [1] 0 0
12 months after radiotherapy
Secondary outcome [1] 0 0
Radiologic complete response
Timepoint [1] 0 0
at baseline, 2 weeks, 3, 6, 9, and 12 months after radiotherapy
Secondary outcome [2] 0 0
Treatment-related adverse events
Timepoint [2] 0 0
at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Secondary outcome [3] 0 0
Patient quality of life
Timepoint [3] 0 0
at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Secondary outcome [4] 0 0
Breast cancer specific quality of life
Timepoint [4] 0 0
at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Secondary outcome [5] 0 0
Patient distress
Timepoint [5] 0 0
at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Secondary outcome [6] 0 0
Physician reported cosmetic outcome
Timepoint [6] 0 0
at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Secondary outcome [7] 0 0
Patient reported cosmetic outcome
Timepoint [7] 0 0
at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Secondary outcome [8] 0 0
Objective cosmetic outcome
Timepoint [8] 0 0
at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy
Secondary outcome [9] 0 0
Local, regional and distant relapse rates
Timepoint [9] 0 0
Day of radiotherapy till end of follow-up of 10 years
Secondary outcome [10] 0 0
Overall survival
Timepoint [10] 0 0
Day of radiotherapy till end of follow-up of 10 years
Secondary outcome [11] 0 0
Radiotherapy-associated immune response markers
Timepoint [11] 0 0
12 months after radiotherapy
Secondary outcome [12] 0 0
Radiotherapy-associated biomarkers
Timepoint [12] 0 0
at baseline, 2 weeks, 3, 6, 9, and 12 months after radiotherapy

Eligibility
Key inclusion criteria
* WHO performance scale =2.
* Females at least 50 years of age with unifocal cT1N0 breast cancer on mammography, ultrasound and MRI.

* Patients with an indication for chemotherapy or HER2-targeted therapy according to Dutch National Oncoline Guidelines or own hospital protocols are not eligible. Patients with an indication for endocrine therapy are eligible.
* Tumor size as assessed on MRI.
* On tumor biopsy:

* Bloom-Richardson grade 1 or 2.
* Non-lobular invasive histological type carcinoma.
* LCIS or (non-extensive) DCIS is accepted.
* ER positive tumor receptor.
* HER2 negative tumor.
* Tumor-negative sentinel node (excluding isolated tumor cells).
* Adequate communication and understanding skills of the Dutch language.
Minimum age
50 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Legal incapacity.
* BRCA1, BRCA2 or CHEK2 gene mutation.
* Distant metastasis.
* Previous history of breast cancer or DCIS.
* Other type of malignancy within 5 years before breast cancer diagnosis. Patients with adequately treated malignancy longer than 5 years before breast cancer diagnosis are eligible for inclusion.
* For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span to breast cancer diagnosis is required for inclusion.
* Collagen synthesis disease.
* Signs of extensive DCIS component on histological biopsy or on imaging (e.g. no extensive calcifications on mammography).
* Invasive lobular carcinoma.
* MRI absolute contraindications as defined by the Department of Radiology.
* Nodal involvement with cytological or histological confirmation.
* Indication for treatment with (neo-)adjuvant chemotherapy.
* Non-feasible dosimetric RT plan.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/08/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2037
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
GenesisCare - Sydney
Recruitment postcode(s) [1] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Netherlands
State/province [1] 0 0
Almere
Country [2] 0 0
Netherlands
State/province [2] 0 0
Amstelveen
Country [3] 0 0
Netherlands
State/province [3] 0 0
Amsterdam
Country [4] 0 0
Netherlands
State/province [4] 0 0
Nijmegen
Country [5] 0 0
Netherlands
State/province [5] 0 0
Zaandam

Funding & Sponsors
Primary sponsor type
Other
Name
Amsterdam UMC, location VUmc
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Dutch Cancer Society
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Desirée van den Bongard, MD, PhD
Address 0 0
Amsterdam UMC, location VUmc
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Yasmin Civil, MD
Address 0 0
Country 0 0
Phone 0 0
020 4441484
Fax 0 0
Email 0 0
y.civil@amsterdamumc.nl
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05350722