Single Dose Ablative Radiation Treatment for Early-Stage Breast Cancer

Breast Neoplasm Clinical Trial

— ABLATIVE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02316561
• Other study ID #: NL46017.041.13
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: April 2018

Study information

• Verified date: July 2018
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

Radiation:
• Single dose ablative radiotherapy
A single dose ablative radiotherapy will be delivered prior to surgery

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tumor related genetic characteristics associated with radiotherapy responsiveness	Future research proposal performed within 10 years after radiotherapy	Until 10 years after radiotherapy
Primary	Pathological complete response		6 months after radiotherapy
Secondary	Radiological tumor response on MRI according to the RECIST criteria		Within 1 week and 2, 4 and 6 months after radiotherapy
Secondary	Radiological tumor response on FDG-PET-CT according to the PERCIST criteria		At 6 months after radiotherapy
Secondary	Quality of life according to EORTC QLQ-BR23 and EORTC QLQ-C30 questionnaires		Until 10 years after radiotherapy
Secondary	Cosmetic results as assessed by patient questionnaire, radiation oncologist evaluation and BCCT.core software		Until 10 years after radiotherapy
Secondary	Frailty assessment according to the Groningen Frailty Indicator		Until 10 years after radiotherapy
Secondary	Functionality assessment using patient questionnaires on physical activity and the Hospital Anxiety and Depression Scale questionnaire.		Until 10 years after radiotherapy
Secondary	Local relapse rates		Until 10 years after radiotherapy
Secondary	Regional relapse rates		Until 10 years after radiotherapy
Secondary	Distant relapse rates		Until 10 years after radiotherapy
Secondary	Disease free survival		Until 10 years after radiotherapy
Secondary	Overall survival		Until 10 years after radiotherapy