RecruitingPhase 2NCT05762900

Ultra-hypofractioNated Adjuvant Radiotherapy ± sImultaneous Integrated Boost for Low-risk Breast Cancer Patients

Ultra-hypofractioNated Radiotherapy ± sImultaneous Integrated Boost for Low-risk(risQue) Breast Cancer Patients After Breast Conservative sUrgery or mastEctomy (UNIQUE)

Sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Enrollment

65 participants

Start Date

Oct 25, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Radiotherapy Side Effect

Summary

This is a phase II study to investigate the feasibility of Ultra-hypofractionated radiotherapy with or without simultaneous integrated boost for low risk breast cancer patients who have received breast conservative surgery of mastectomy.

Eligibility

Sex: FEMALEMin Age: 35 Years

Inclusion Criteria9

Patients diagnosed with invasive or non-invasive breast cancer;
The patients have undergone breast-conserving surgery or mastectomy with axillary sentinel nodal biopsy or dissection;
Stage ypT0-2N0-1 (if receive neoadjuvant therapy) or stage pT0-2N0-1 (if receive upfront surgery).
No distant metastasis;
Life expectancy ≥6 months;
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.);
Patients are willing to cooperate to follow up;
Patients should sign the informed consent;
Women of childbearing age need effective contraception.

Exclusion Criteria7

Biopsy proven ipsilateral supraclavicular, infraclavicular or internal mammary nodal involvement.
Concurrent or previous neuropathy overlapping with the radiation volume or brachial plexus injury;
Patients who had radiotherapy to the ipsilateral breast, lymph-drainage regions or adjacent areas before;
Concurrent active connective tissue disease;
Other malignancies, which affect patient life expectancy (except adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder neoplasms (no more than T1), early stage thyroid carcinoma);
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).
Pregnant or breast-feeding.

Interventions

RADIATIONUltra-fractionated radiation therapy

5.2Gy per fraction for 5 fractions with an integrated boost of 6Gy per fraction.

Locations(1)

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, China

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NCT05762900