Preoperative tumor-bed boost followed by oncoplastic surgery for early stage breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the feasibility of administering a preoperative single-dose tumor-bed boost of radiation followed by oncoplastic breast-conserving surgery and ultra-hypofractionated postoperative radiotherapy in patients with early stage breast cancer. Patients under 55 years old who are eligible for breast-conserving surgery will receive a 10Gy dose to the tumor bed using MRI-guided radiotherapy before surgery. The study aims to evaluate acute toxicities, surgical complications, oncologic outcomes, and quality of life after treatment. The approach combines advanced imaging and targeted radiation to improve surgical outcomes and minimize side effects.

Why it matters

Who can join: the full rules

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).

Where it's running

• 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 Recruiting

Study contacts

• Principal investigator: Hao Jing, M.D. — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Hao Dong, M.D.
• Email: howelu1349@hotmail.com
• Phone: +861087787678

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.