Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients

NCT05350722 | Recruiting DMC

• 1 other identifier: NL77000.029.21
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 7

Brief Summary

In this ABLATIVE-2 trial, low-risk breast cancer patients will be treated with MRI-guided single dose preoperative partial breast radiotherapy to assess the rate of pathologic complete response after an interval of six to twelve months between radiotherapy and surgery. Response monitoring will be assessed using MRI and markers in blood and tumor tissue to enable prediction of pathologic response.

Conditions

Breast Cancer

Keywords

Low-risk breast cancer; Early stage breast cancer; Pre-operative radiotherapy; Partial breast irradiation; Pre-operative single dose radiation; pathologic complete response; cosmetic outcome; survival; toxicity; quality of life; neo-adjuvant radiotherapy; oncological outcomes

Outcome Measures

Primary Outcomes (1)

• Pathologic complete response

  pCR is defined as the absence of residual invasive cancer on resected breast specimen

  12 months after radiotherapy

Secondary Outcomes (12)

• Radiologic complete response

  at baseline, 2 weeks, 3, 6, 9, and 12 months after radiotherapy

• Treatment-related adverse events

  at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy

• Patient quality of life

  at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy

• Breast cancer specific quality of life

  at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy

• Patient distress

  at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy

Study Arms (1)

Pre-operative single dose partial breast irradiation

EXPERIMENTAL

Radiation: Single dose ablative radiotherapy

Interventions

Single dose ablative radiotherapy RADIATION

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

Pre-operative single dose partial breast irradiation

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Legal incapacity.
• BRCA1, BRCA2 or CHEK2 gene mutation.
• Distant metastasis.
• Previous history of breast cancer or DCIS.
• 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.

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead
• Dutch Cancer Society: collaborator

Study Sites (7)

GenesisCare

Sydney, Australia

NOT YET RECRUITING

Flevoziekenhuis

Almere Stad, Netherlands

RECRUITING

Ziekenhuis Amstelland

Amstelveen, Netherlands

RECRUITING

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

Canisius Wilhelmina Ziekenhuis

Nijmegen, Netherlands

RECRUITING

Radboud UMC

Nijmegen, Netherlands

RECRUITING

Zaans Medisch Centrum

Zaandam, Netherlands

RECRUITING

Related Publications (1)

• 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.

  PMID: 37161377 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Pathologic Complete Response

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Progression; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Desirée van den Bongard, MD, PhD

  Amsterdam UMC, location VUmc

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasmin Civil, MD

CONTACT

020 4441484; y.civil@amsterdamumc.nl

Desirée van den Bongard, MD, PhD

CONTACT

h.j.vandenbongard@amsterdamumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 28, 2022
• Study Start: August 24, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2037
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); NL (6)