Single Dose Ablative Radiation Treatment for Early-Stage Breast Cancer (ABLATIVE)

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasm
• Intervention / Treatment: Radiation: Single dose ablative radiotherapy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht, Netherlands, 3584 CX
    • University Medical Center Utrecht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single dose ablative radiotherapy; Eligible patients for single dose ablative radiotherapy according to inclusion and exclusion criteria	Radiation: Single dose ablative radiotherapy; A single dose ablative radiotherapy will be delivered prior to surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pathological complete response	6 months after radiotherapy

Secondary Outcome Measures

Outcome Measure	Time Frame
Radiological tumor response on MRI according to the RECIST criteria	Within 1 week and 2, 4 and 6 months after radiotherapy
Radiological tumor response on FDG-PET-CT according to the PERCIST criteria	At 6 months after radiotherapy
Quality of life according to EORTC QLQ-BR23 and EORTC QLQ-C30 questionnaires	Until 10 years after radiotherapy
Cosmetic results as assessed by patient questionnaire, radiation oncologist evaluation and BCCT.core software	Until 10 years after radiotherapy
Frailty assessment according to the Groningen Frailty Indicator	Until 10 years after radiotherapy
Functionality assessment using patient questionnaires on physical activity and the Hospital Anxiety and Depression Scale questionnaire.	Until 10 years after radiotherapy
Local relapse rates	Until 10 years after radiotherapy
Regional relapse rates	Until 10 years after radiotherapy
Distant relapse rates	Until 10 years after radiotherapy
Disease free survival	Until 10 years after radiotherapy
Overall survival	Until 10 years after radiotherapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor related genetic characteristics associated with radiotherapy responsiveness	Future research proposal performed within 10 years after radiotherapy	Until 10 years after radiotherapy

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Investigators: Principal Investigator: HJGD van den Bongard, MD, PhD, UMC Utrecht

Publications and helpful links

General Publications

• Groot Koerkamp ML, de Hond YJM, Maspero M, Kontaxis C, Mandija S, Vasmel JE, Charaghvandi RK, Philippens MEP, van Asselen B, van den Bongard HJGD, Hackett SS, Houweling AC. Synthetic CT for single-fraction neoadjuvant partial breast irradiation on an MRI-linac. Phys Med Biol. 2021 Apr 16;66(8). doi: 10.1088/1361-6560/abf1ba.
• Charaghvandi RK, van Asselen B, Philippens ME, Verkooijen HM, van Gils CH, van Diest PJ, Pijnappel RM, Hobbelink MG, Witkamp AJ, van Dalen T, van der Wall E, van Heijst TC, Koelemij R, van Vulpen M, van den Bongard HJ. Redefining radiotherapy for early-stage breast cancer with single dose ablative treatment: a study protocol. BMC Cancer. 2017 Mar 9;17(1):181. doi: 10.1186/s12885-017-3144-5.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Actual): April 1, 2018
• Study Completion (Actual): April 1, 2018

Study Registration Dates

• First Submitted: October 10, 2014
• First Submitted That Met QC Criteria: December 12, 2014
• First Posted (Estimate): December 15, 2014

Study Record Updates

• Last Update Posted (Actual): July 20, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: NL46017.041.13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO