Single Dose Ablative Radiation Treatment for Early-Stage Breast Cancer

Conditions

Breast Neoplasm

Brief 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.

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.

Civil YA, Vasmel JE, Charaghvandi RK, Houweling AC, Vreuls CPH, van Diest PJ, Witkamp AJ, Doeksen A, van Dalen T, Felderhof J, van Dam I, Slotman BJ, Kirby AM, Verkooijen HM, van der Velde S, van der Leij F, van den Bongard HJGD.

2024-08-029 citations

10.1016/j.ijrobp.2024.07.2326

Prediction of pathologic complete response after single-dose MR-guided partial breast irradiation in low-risk breast cancer patients: the ABLATIVE-2 trial—a study protocol

Yasmin A. Civil, Arlene L. Oei, Katya M. Duvivier, Nina Bijker, Philip Meijnen et al. (21 authors)

BMC Cancer2023-05-0918 citations

10.1186/s12885-023-10910-6

Single fraction ablative preoperative radiation treatment for early-stage breast cancer: the CRYSTAL study – a phase I/II clinical trial protocol

Maria Alessia Zerella, Mattia Zaffaroni, Giuseppe Ronci, Samantha Dicuonzo, Damaris Patricia Rojas et al. (23 authors)

BMC Cancer2022-04-0217 citations

10.1186/s12885-022-09305-w

Redefining radiotherapy for early-stage breast cancer with single dose ablative treatment: a study protocol.

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.

2017-03-0933 citations

10.1186/s12885-017-3144-5

Interventions

RADIATIONSingle dose ablative radiotherapy

A single dose ablative radiotherapy will be delivered prior to surgery

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

50 Years to No maximum

Healthy volunteers

No

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.

Design outcomes

Primary

Measure	Time frame
Pathological complete response	6 months after radiotherapy

Secondary

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

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

Countries

Netherlands

Outcome results

None listed