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NCT05603078Recruiting

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

Source: ClinicalTrials.gov · Last updated 2 Nov 2022 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
102 (estimated)
First submitted
22 Oct 2022
Start date
21 Jun 2022
Primary completion date
19 Jul 2026
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
NCT number
NCT05603078

What you commit to

  • Study type: Interventional
  • Planned participants: 102
  • From 21 Jun 2022 to the primary completion date, 19 Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Concurrent active connective tissue disease;
  • Patients who had radiotherapy to the ipsilateral breast or adjacent areas before;

Other illness

  • 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));

Lab values

  • 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).

Who the study is looking for

  • 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.

Age in the registry: - to 55 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.