Last updated: November 1, 2022
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Overall Status: Active - Recruiting
Phase
N/A
Condition
N/ATreatment
N/AClinical Study ID
NCT05603078
NCC2021291
Ages < 55 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 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-conservingoncoplastic surgery;
- No distant metastasis;
- The primary tumour> 5mm from the skin, without invasion of the ribs or intercostalmuscles;
- 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/aspartateaminotransferase ≤2.5×UNL.);
- Patients are willing to cooperate to follow up;
- Patients should sign the informed consent;
- Women of childbearing age need effective contraception.
Exclusion
Exclusion Criteria:
- Concurrent active connective tissue disease;
- Patients who had radiotherapy to the ipsilateral breast or adjacent areas before;
- Other malignancies, which affect pateint life expectancy (except adequately treatedbasal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladderneoplasms (no more than T1));
- Severe comorbidities or active disease (Poorly controlled heart disease: New YorkClassification of Cardiac Function ≥ Grade 2, active coronary heart disease, unstableangina pectoris, arrhythmia requiring medical treatment/persistent refractoryhypertension; Myocardial infarction, stroke within six months; Poorly controlleddiabetes persists. Fasting blood glucose ≥ 10mmol/L, 2 hours postprandial bloodglucose ≥ 13 mmol/L. Poorly controlled psychosis develops or worsens within sixmonths; Active infection; Positive for antibodies to HIV).
Study Design
Total Participants: 102
Study Start date:
June 21, 2022
Estimated Completion Date:
July 31, 2028
Study Description
Connect with a study center
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing 100021
ChinaActive - Recruiting
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