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

NCT ID: NCT05603078

Last Updated: 2022-11-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-21
• Study Completion Date: 2028-07-31

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.

Detailed Description

This is a prospective, non-controlled, feasitility study. The tumor-bed boost part of the radiotherpay is put forward, 7-14 days before the definitive surgery. A single dose of 10Gy is prescribed to the tumor bed. In order to identify the tumor accurately, MRI guided radiotherapy is applied under the MR-linac. The breast surgery is planned after recovery from radiation induced acute toxicity, within 14 days. The surgeons would undertake lumpectomy only or an additional oncoplastic surgery, with axillary nodal evaluation with sentinal nodal biopsy or dissection. After wound healing, postoperative whole breast radiotherapy is administered, within 6 weeks following surgery. The dose is 26Gy/5.2Gy/5 fractions. Adjuvant systemic therapy is held until the end of the radiotherapy, no more than 12 weeks from surgery implementation.

Conditions

Breast Neoplasms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

preoperative tumor-bed boost

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

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

Preoperative 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.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

1. Patients diagnosed with invasive breast cancer;

2. cN0 based on clinical physical examination combined with at least two imaging tests, or axillary fine-needle biopsy proved pN0;

3. Patients who plan to receive breast-conserving surgery or breast-conserving oncoplastic surgery;

4. No distant metastasis;

5. The primary tumour> 5mm from the skin, without invasion of the ribs or intercostal muscles;

6. No neoadjuvant systemic therapy;

7. Patients who can tolerate MRI;

8. Life expectancy ≥5 years;

9. 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.);

10. Patients are willing to cooperate to follow up;

11. Patients should sign the informed consent;

12. Women of childbearing age need effective contraception.

Exclusion Criteria

1. Concurrent active connective tissue disease;

2. Patients who had radiotherapy to the ipsilateral breast or adjacent areas before;

3. 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));

4. 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).

• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

HAO JING

professor of medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jing Wang, M.D.

Role: STUDY_CHAIR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Shu-lian Wang, M.D.

Role: STUDY_CHAIR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Hao Jing, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Xiang-yi Kong, M.D.

Role: STUDY_DIRECTOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

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

Site Status: RECRUITING

Countries

China

Central Contacts

Hao Dong, M.D.

Role: CONTACT

howelu1349@hotmail.com

+861087787678

Hao Jing, M.D.

Role: CONTACT

owletskim@163.com

+861087788281

Facility Contacts

Hao Jing, M.D.

Role: primary

owletskim@163.com

+861087788281

Hao Dong, M.D.

Role: backup

howelu1349@hotmail.com

+861087787678

References

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.

Reference Type: DERIVED

PMID: 39264581 (View on PubMed)

Other Identifiers

NCC2021291

Identifier Type: -

Identifier Source: org_study_id