Actively Recruiting
A Prospective Study of Preoperative Tumor-bed Boost Followed by Oncoplastic Surgery and Adjuvant Whole Breast Radiotherapy for Early Stage Breast Cancer (BIRKIN)
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2022-11-02
102
Participants Needed
1
Research Sites
314 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Prospective Study of Preoperative Tumor-bed Boost Followed by Oncoplastic Surgery and Adjuvant Whole Breast Radiotherapy for Early Stage Breast Cancer (BIRKIN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with invasive breast cancer
- Clinically node-negative status confirmed by examination and at least two imaging tests or axillary fine-needle biopsy
- Planned breast-conserving surgery or oncoplastic breast-conserving surgery
- No distant metastasis
- Primary tumor more than 5mm from skin without rib or intercostal muscle invasion
- No prior neoadjuvant systemic therapy
- Able to tolerate MRI
- Life expectancy of at least 5 years
- Adequate organ function (Hemoglobin 100g/L, leukocytes 2109/L, neutrophils 1109/L, platelets 80109/L; Creatinine 1.5 mg/dl; ALT/AST 2.5 times upper normal limit)
- Willingness to comply with follow-up
- Signed informed consent
- Women of childbearing age must use effective contraception
You will not qualify if you...
- Active connective tissue disease
- Previous radiotherapy to the same breast or adjacent areas
- Other malignancies affecting life expectancy except treated basal cell carcinoma, cervical carcinoma in situ, or superficial bladder tumors (no more than T1)
- Severe or uncontrolled comorbidities including heart disease (NYHA grade 2), recent myocardial infarction or stroke, poorly controlled diabetes, worsening psychosis, active infection, or HIV positive
AI-Screening
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Trial Site Locations
Total: 1 location
1
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, 100021
Actively Recruiting
Research Team
H
Hao Dong, M.D.
CONTACT
H
Hao Jing, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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