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

Last updated: November 1, 2022
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT05603078
NCC2021291
  • Ages < 55
  • Female

Study 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 Criteria

Inclusion

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-conservingoncoplastic surgery;
  4. No distant metastasis;
  5. The primary tumour> 5mm from the skin, without invasion of the ribs or intercostalmuscles;
  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/aspartateaminotransferase ≤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

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 treatedbasal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladderneoplasms (no more than T1));
  4. Severe comorbidities or active disease (Poorly controlled heart disease: New YorkClassification of Cardiac Function ≥ Grade 2, active coronary heart disease, unstableangina pectoris, arrhythmia requiring medical treatment/persistent refractoryhypertension; Myocardial infarction, stroke within six months; Poorly controlleddiabetes persists. Fasting blood glucose ≥ 10mmol/L, 2 hours postprandial bloodglucose ≥ 13 mmol/L. Poorly controlled psychosis develops or worsens within sixmonths; Active infection; Positive for antibodies to HIV).

Study Design

Total Participants: 102
Study Start date:
June 21, 2022
Estimated Completion Date:
July 31, 2028

Study 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.

Connect with a study center

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

    Beijing, Beijing 100021
    China

    Active - Recruiting

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