RecruitingNot ApplicableNCT05603078

A Prospective Study of Preoperative Tumor-bed Boost Followed by Oncoplastic Surgery and Adjuvant Whole Breast Radiotherapy for Early Stage Breast Cancer (BIRKIN)

A Prospective Study of Preoperative MRI Linac-based Tumor-bed Boost Followed by Breast-conservative Oncoplastic Surgery and Adjuvant Ultra-hypofractionated Whole Breast Radiotherapy for Early Stage Breast Cancer

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

102 participants

Start Date

Jun 21, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Neoplasms

Summary

This study explores the feasibility of preoperative single-dose tumor-bed boost followed by oncoplastic breast-conserving surgery and ultra-hypofractionated postoperative radiotherapy in patients with early stage breast cancer. Patients less than 55 years old, who are diagnosed with breast cancer and are eligible to recieve breast-conserving surgery are enrolled. Patients who are older than 55 years, with suspected regional lymph node metastasis are excluded. The primary end point are the acute toxicities within 4 weeks after adjuvant radiation. The secondary endpoints are oncologic outcomes, surgical complications within 30 days, late toxicities, patients' quality of life and cosmetic outcomes.

Eligibility

Sex: FEMALEMax Age: 55 Years

Inclusion Criteria12

Patients diagnosed with invasive breast cancer;
cN0 based on clinical physical examination combined with at least two imaging tests, or axillary fine-needle biopsy proved pN0;
Patients who plan to receive breast-conserving surgery or breast-conserving oncoplastic surgery;
No distant metastasis;
The primary tumour\> 5mm from the skin, without invasion of the ribs or intercostal muscles;
No neoadjuvant systemic therapy;
Patients who can tolerate MRI;
Life expectancy ≥5 years;
Organ function is fine (Hemoglobin ≥100g/L, leukocyte ≥2×109/L, neutrophil ≥1×109/L, platelet ≥80×109/L; Creatinine 1.5 mg/dl or less; Alanine aminotransferase/aspartate aminotransferase ≤2.5×UNL.);
Patients are willing to cooperate to follow up;
Patients should sign the informed consent;
Women of childbearing age need effective contraception.

Exclusion Criteria4

Concurrent active connective tissue disease;
Patients who had radiotherapy to the ipsilateral breast or adjacent areas before;
Other malignancies, which affect pateint life expectancy (except adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder neoplasms (no more than T1));
Severe comorbidities or active disease (Poorly controlled heart disease: New York Classification of Cardiac Function ≥ Grade 2, active coronary heart disease, unstable angina pectoris, arrhythmia requiring medical treatment/persistent refractory hypertension; Myocardial infarction, stroke within six months; Poorly controlled diabetes persists. Fasting blood glucose ≥ 10mmol/L, 2 hours postprandial blood glucose ≥ 13 mmol/L. Poorly controlled psychosis develops or worsens within six months; Active infection; Positive for antibodies to HIV).

Interventions

RADIATIONPreoperative MRI-guided tumor-bed boost and postopreative ultra-hypofractionated radiotherapy (26 Gy/5.2Gy/5)

Preoperative tumor-bed boost was performed under MRI Linac, and a single dose of 10Gy is prescribed. The postoperative radiotherapy of 26Gy/5.2Gy/5 fractions is within 6 weeks following surgery. Adjuvant chemotherapy, targeted therapy and endocrine therapy are initiated no more than 12 weeks after surgery.

Locations(1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, China

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NCT05603078