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

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

This study is testing if giving a special dose of radiation to the tumor area before surgery can help younger patients with early stage breast cancer have better surgery results and fewer side effects.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 102 (estimated)
• Ages: N/A to 55 Years
• Sex: Female
• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences (other)
• Drugs / interventions: radiation
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT05603078 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are women under 55 years old diagnosed with invasive breast cancer who are eligible for breast-conserving surgery.

Not a fit: Patients over 55 years old or those with suspected regional lymph node metastasis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could enhance surgical outcomes and reduce treatment-related toxicities for patients with early stage breast cancer.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving outcomes with preoperative radiotherapy in breast cancer treatment.

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).

Where this trial is running

Beijing, Beijing Municipality

• 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.

Conditions: Breast Neoplasms, Breast cancer, MRI guided radiotherapy, Pre-operative radiotherapy, Ultra-hypofractionation