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

NCT05603078 | Recruiting

• 1 other identifier: NCC2021291
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Neoplasms

Keywords

Breast cancer; MRI guided radiotherapy; Pre-operative radiotherapy; Ultra-hypofractionation

Outcome Measures

Primary Outcomes (1)

• The rate of patients who develop radiation-associated acute toxicity (≥ 2 degree)

  We will record the incidence of ≥ 2 degree radiation-associated acute toxicity, such as breast or chest wall oedema, acute dermatitis, breast pain,itch of breast skin. The incidence of all the above is the primary outcome.

  until 4 weeks of postoperative radiotherapy

Secondary Outcomes (9)

• Local recurrence rate

  Until 5 years after diagnosis.

• Local regional recurrence rate

  Until 5 years after diagnosis.

• Disease-free survival

  Until 5 years after diagnosis.

• Overall survival

  Until 5 years after diagnosis.

• Complications of surgery in the short term.

  Until 30 days after the surgery.

Study Arms (1)

preoperative tumor-bed boost

EXPERIMENTAL

The participants receive preoperative tumor-bed boost, oncoplastic surgery and adjuvant WBRT±RNI.

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

Interventions

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

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.

preoperative tumor-bed boost

Eligibility Criteria

• Age: Up to 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (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, 100021, China

RECRUITING

Related Publications (1)

• Dong H, Jing H, Wang XY, Kong XY, Wang YP, Zhai YR, Che SN, Fang Y, Wang SL, Wang J. Exploring the feasibility of preoperative tumor-bed boost, oncoplastic surgery, and adjuvant radiotherapy schedule in early-stage breast cancer: a phase II clinical trial. Int J Surg. 2025 Jan 1;111(1):382-393. doi: 10.1097/JS9.0000000000002073.

  PMID: 39264581 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jing Wang, M.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

• Shu-lian Wang, M.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

• Hao Jing, M.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Xiang-yi Kong, M.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY DIRECTOR

Central Study Contacts

Hao Dong, M.D.

CONTACT

+861087787678; howelu1349@hotmail.com

Hao Jing, M.D.

CONTACT

+861087788281; owletskim@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor of medicine

Study Record Dates

• First Submitted: October 22, 2022
• First Posted: November 2, 2022
• Study Start: June 21, 2022
• Primary Completion (Estimated): July 19, 2026
• Study Completion (Estimated): July 1, 2028
• Last Updated: November 2, 2022

Record last verified: 2022-10

Locations

CN (1)