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

Amsterdam UMC, location VUmc100 enrolled

Overview

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.

Patients will receive single-dose preoperative radiotherapy followed by breast conserving surgery (BCS) at 12 months after radiotherapy, as long as follow-up MRI scans show a complete radiologic response. In case of incomplete radiologic response, BCS will be performed at 6 months after radiotherapy. BCS is performed earlier when progressive disease is found on MRI. In the follow-up period between radiotherapy and surgery, tumor response will be monitored using MRI every 3 months. After surgery, patients will be followed up until 10 years after radiotherapy treatment to assess oncological outcomes, toxicity, cosmetic outcome and quality of life.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Breast Cancer

Interventions

Single dose ablative radiotherapyRADIATION

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

Sex: FEMALEMin age: 50 Years

Medical Language ↔ Plain English

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. 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.

Locations (7)

GenesisCare

Sydney, Australia

NOT_YET_RECRUITING

Flevoziekenhuis

Almere Stad, Netherlands

RECRUITING

Ziekenhuis Amstelland

Amstelveen, Netherlands

RECRUITING

Outcomes

Primary Outcomes

Pathologic complete response

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

Time frame: 12 months after radiotherapy

Secondary Outcomes

Radiologic complete response

Radiologic complete response (rCR) is defined as complete absence of pathologic contrast enhancement in the original tumor bed and complete absence of pathologic ADC (apparent diffusion coefficient) reduction in the original tumor bed. rCR is reported according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 guidelines.

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

Treatment-related adverse events

Number of participants with treatment-related adverse events as assessed by the Common Terminology Criteria Adverse Events version 5.0

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

Patient quality of life

PROMs are assessed using the European Organization for Research and Treatment of Cancer core-30 quality of life questionnaire (EORTC QLQ-C30)

Time frame: 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

PROMs are assessed using the European Organization for Research and Treatment of Cancer breast cancer-specific quality of life questionnaire (EORTC QLQ-BR23)

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

Patient distress

PROMs are assessed using the Hospital Anxiety and Depression Scale (HADS) questionnaire

Central Contacts

Yasmin Civil, MD

CONTACT

020 4441484 y.civil@amsterdamumc.nl

Desirée van den Bongard, MD, PhD

CONTACT

h.j.vandenbongard@amsterdamumc.nl

Data from ClinicalTrials.gov

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