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Completed

NCT Number: NCT02316561

Single Dose Ablative Radiation Treatment for Early-Stage Breast Cancer

The purpose of the study is to investigate the feasibility of a preoperative, single dose, ablative partial breast radiation treatment in patients with early-stage breast cancer.

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Key information

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

About this study

A total of twenty-five patients will be treated with a single dose preoperative ablative radiation treatment. After a vigilant follow-up with MRI, breast conserving surgery will be performed 6 months after the ablative radiation treatment. The total follow-up time is 10 years.

This study aims to present an ablative radiotherapy treatment approach that could resolve to some extent the disadvantages of current breast conserving treatment in elderly low-risk breast cancer patients who are currently not treated according to guidelines due to co-morbidity.

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 or females at least 70 years of age with an unifocal cT1-2(maximum 3 cm)N0 breast cancer:
  • Tumor size as assessed on MRI
  • On tumor biopsy:
  • Non-lobular invasive histological type carcinoma.
  • LCIS is accepted.
  • ER positive tumor receptor.
  • Tumor negative sentinel node.
  • Adequate communication and understanding skills of the Dutch language.

Exclusion criteria

  • Legal incapacity
  • Indication for chemotherapy or immunotherapy (i.e. patients with an indication for endocrine therapy are eligible)
  • BRCA gene mutation.
  • Previous history of breast cancer
  • Other type of malignancy within 5 years before breast cancer diagnosis. For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span from breast cancer diagnosis is required for inclusion
  • Her2neu positive tumor.
  • Previous history of ipsilateral breast surgery and impaired cosmetic outcome, as assessed by the treating surgeon or radiation-oncologist.
  • Collagen synthesis disease.
  • Signs of extensive DCIS component on histological biopsy or mammogram.
  • Invasive lobular carcinoma.
  • MRI absolute contraindications as defined by the Radiology Department.
  • Nodal involvement with cytological or histological confirmation.
  • Treatment with neo-adjuvant systemic therapy.

Treatment and study plan

Single dose ablative radiotherapy

Radiation

A single dose ablative radiotherapy will be delivered prior to surgery

Primary outcomes

  1. Pathological complete response

    Time frame: 6 months after radiotherapy

Secondary outcomes

  1. Radiological tumor response on MRI according to the RECIST criteria

    Time frame: Within 1 week and 2, 4 and 6 months after radiotherapy

  2. Radiological tumor response on FDG-PET-CT according to the PERCIST criteria

    Time frame: At 6 months after radiotherapy

  3. Quality of life according to EORTC QLQ-BR23 and EORTC QLQ-C30 questionnaires

    Time frame: Until 10 years after radiotherapy

  4. Cosmetic results as assessed by patient questionnaire, radiation oncologist evaluation and BCCT.core software

    Time frame: Until 10 years after radiotherapy

  5. Frailty assessment according to the Groningen Frailty Indicator

    Time frame: Until 10 years after radiotherapy

  6. Functionality assessment using patient questionnaires on physical activity and the Hospital Anxiety and Depression Scale questionnaire.

    Time frame: Until 10 years after radiotherapy

  7. Local relapse rates

    Time frame: Until 10 years after radiotherapy

  8. Regional relapse rates

    Time frame: Until 10 years after radiotherapy

  9. Distant relapse rates

    Time frame: Until 10 years after radiotherapy

  10. Disease free survival

    Time frame: Until 10 years after radiotherapy

  11. Overall survival

    Time frame: Until 10 years after radiotherapy

Other outcomes

  1. Tumor related genetic characteristics associated with radiotherapy responsiveness

    Time frame: Until 10 years after radiotherapy

    Future research proposal performed within 10 years after radiotherapy

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study title

Single Dose Ablative Preoperative Radiation Treatment for Early-Stage Breast Cancer in Elderly Patients

Acronym: ABLATIVE

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Dec 15, 2014
Registry last updated
Jul 20, 2018

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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