Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients
NCT ID: NCT05350722
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2022-08-24
2037-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pre-operative single dose partial breast irradiation
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
50 Years
FEMALE
No
Sponsors
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Amsterdam UMC, location VUmc
OTHER
Dutch Cancer Society
OTHER
Responsible Party
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Desiree H.J.G.D. van den Bongard, MD Ph
MD, PhD
Principal Investigators
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Desirée van den Bongard, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Amsterdam UMC, location VUmc
Locations
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GenesisCare
Sydney, , Australia
Flevoziekenhuis
Almere Stad, , Netherlands
Ziekenhuis Amstelland
Amstelveen, , Netherlands
Amsterdam UMC
Amsterdam, , Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, , Netherlands
Radboud UMC
Nijmegen, , Netherlands
Zaans Medisch Centrum
Zaandam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Gillian Lamoury, MD
Role: primary
Gwen Diepenhorst, MD PhD
Role: primary
Astrid Baan, MD
Role: primary
Yasmin Civil, MD
Role: primary
Dominique van Uden, MD PhD
Role: primary
Paulien Westhoff, MD PhD
Role: primary
Sandra Muller, MD PhD
Role: primary
References
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Civil YA, Oei AL, Duvivier KM, Bijker N, Meijnen P, Donkers L, Verheijen S, van Kesteren Z, Palacios MA, Schijf LJ, Barbe E, Konings IRHM, -van der Houven van Oordt CWM, Westhoff PG, Meijer HJM, Diepenhorst GMP, Thijssen V, Mouliere F, Slotman BJ, van der Velde S, van den Bongard HJGD. Prediction of pathologic complete response after single-dose MR-guided partial breast irradiation in low-risk breast cancer patients: the ABLATIVE-2 trial-a study protocol. BMC Cancer. 2023 May 9;23(1):419. doi: 10.1186/s12885-023-10910-6.
Other Identifiers
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NL77000.029.21
Identifier Type: -
Identifier Source: org_study_id