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NCT Number: NCT05350722

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

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.

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Key information

Conditions

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

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

GenesisCare, Sydney, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Pathologic complete response

    Time frame: 12 months after radiotherapy

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

Secondary outcomes

  1. Radiologic complete response

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

    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.

  2. Treatment-related adverse events

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

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

  3. Patient quality of life

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

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

  4. Breast cancer specific quality of life

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

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

  5. Patient distress

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

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

  6. Physician reported cosmetic outcome

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

    Cosmetic outcome is assessed by the physician using a questionnaire

  7. Patient reported cosmetic outcome

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

    Cosmetic outcome is assessed by the patient using the BREAST-Q questionnaire. .

  8. Objective cosmetic outcome

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

    Cosmetic outcome is assessed objectively using images captured using the VECTRA XT 3D-imaging system. This three-dimensional surface-imaging system uses stereophotogrammetry to estimate x, y, z coordinates of the imaged surface. These coordinates will be used to calculate the volume-shape-symmetry measure.

  9. Local, regional and distant relapse rates

    Time frame: Day of radiotherapy till end of follow-up of 10 years

    A local recurrence is defined as disease occurrence in the ipsilateral breast. A regional recurrence is defined as nodal occurrence in the ipsilateral axilla, internal mammary, infraclavicular or supraclavicular region. A distant metastasis defined as disease occurrence in the contralateral breast or contralateral breast nodal region or another organ than breast involvement.

  10. Overall survival

    Time frame: Day of radiotherapy till end of follow-up of 10 years

    Overall survival will be calculated from the date of the radiotherapy treatment until the time of breast-cancer related death or breast-cancer unrelated death.

  11. Radiotherapy-associated immune response markers

    Time frame: 12 months after radiotherapy

    Immune response markers as CD3, CD4, CD8 and FOXP3 will be assessed in tumor tissue after surgery.

  12. Radiotherapy-associated biomarkers

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

    ctDNA will be assessed in blood samples taken between radiotherapy and surgery.

Study contacts

Contact information is provided by the study sponsor or research team.

Desirée van den Bongard, MD, PhD

CONTACT

[email protected]

Janneke van Roij, MD

CONTACT

[email protected]

+31 6 11094077

Sponsors and collaborators

Lead sponsor

Amsterdam UMC, location VUmc

Other

Collaborators

  • Dutch Cancer Society

Registry information

Acronym: ABLATIVE-2

Important dates

Study start
2022
Primary completion
2027
Study completion
2037
First posted
Apr 28, 2022
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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