At a glance
ClinicalIndex Comparison Record- ✓Invasive breast cancer diagnosis
- ✓cN0 by clinical exam plus ≥2 imaging tests, or axillary biopsy-proven pN0
- ✓Planned breast-conserving surgery or breast-conserving oncoplastic surgery
- ✓No distant metastasis
- ✕Active connective tissue disease
- ✕Prior radiotherapy to ipsilateral breast or adjacent areas
- ✕Other malignancies affecting life expectancy (except basal cell carcinoma, cervical carcinoma in situ, or superficial bladder neoplasms ≤T1)
- ✕Poorly controlled heart disease (NYHA ≥Grade 2), active coronary heart disease, unstable angina, or arrhythmia requiring treatment/refractory hypertension
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Preoperative MRI-guided tumor-bed boost and postopreative ultra-hypofractionated radiotherapy (26 Gy/5.2Gy/5) for Breast Neoplasms. Currently recruiting, targeting 102 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.