Single Pre-Operative Radiation Therapy - With Delayed Surgery for Low Risk Breast Cancer

Conditions

Breast Cancer

Keywords

radiation therapy

Brief summary

To study a single dose of preoperative partial radiotherapy to a low-risk breast tumour. The radiotherapy will be goven 3 months before surgery.

Danny Lavigne, Tarek Hijal, Peter Vavassis, Marie‐Christine Guilbert, Lucas Sidéris et al. (13 authors)

Radiotherapy and Oncology2024-08-308 citations

10.1016/j.radonc.2024.110515

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

Interventions

RADIATIONSingle Pre-Operative Radiation Therapy - with Delayed Surgery

Single Pre-Operative Radiation Therapy - with Delayed Surgery

Study design

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

65 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Female aged 65 years or older 2. World Health Organization (WHO) performance status 0-2 3. Invasive ductal carcinoma proven by biopsy done ≤ 12 weeks from treatment start 4. Unifocal disease on preoperative staging ultrasound done ≤ 12 weeks from treatment start 5. Tumors less than 2cm clinically on physical exam, as well as on breast ultrasound 6. No clinical evidence of nodal disease (i.e. cN0), on physical examination done ≤ 12 weeks from treatment start, as well as on breast ultrasound 7. Estrogen receptor status (ER) positive on biopsy 8. Her2 negative on biopsy 9. Grade 1 or 2 on biopsy 10. Planned surgery is a partial mastectomy with sentinel lymph node biopsy 11. Localisation markers placed before treatment

Exclusion criteria

1. Age less than 65 years 2. A known deleterious mutation in BRCA 1 and/or BRCA 2 3. Clinical tumor size \> 2.0 cm in greatest diameter on staging ultrasound 4. Tumor histology limited to lobular carcinoma only 5. Clinically positive axillary nodes (cN+) 6. Lymphovascular invasion on biopsy 7. Pure ductal or lobular carcinoma in situ on biopsy 8. Extensive intraductal component on biopsy 9. Neoadjuvant hormonal manipulation or chemotherapy 10. Prior history of cancer (Patients with prior or concurrent basal cell or squamous cell skin cancers are eligible for the trial) 11. More than one primary tumor in different quadrants of the same breast 12. Diffuse microcalcifications on mammography 13. Paget's disease of the nipple 14. Previous irradiation to the ipsilateral breast 15. Presence of an ipsilateral breast implant or pacemaker 16. Serious non-malignant disease (e.g. cardiovascular, pulmonary, systemic lupus erythematosus (SLE), scleroderma) which would preclude definitive radiation treatment 17. Estrogen receptor status (ER) not known 18. Currently pregnant or lactating 19. Psychiatric or addictive disorders which would preclude obtaining informed consent or adherence to protocol 20. Geographic inaccessibility for follow-up 21. Lack of preoperative staging with breast and axillary ultrasound 22. Inability to adequately plan the patient for the experimental technique

Design outcomes

Primary

Measure	Time frame
rate of pathological complete response	at the time of surgery

Secondary

Measure	Time frame
incidence of radiation toxicity	in the 2 years after treatment

Countries

Canada

Outcome results

None listed