Radiotherapy options for low-risk breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II study investigates the feasibility of ultra-hypofractionated radiotherapy, with or without a simultaneous integrated boost, for patients with low-risk breast cancer who have undergone breast-conserving surgery or mastectomy. Participants will receive radiation treatment consisting of 5.2Gy for 5 fractions to prophylactic areas and a 6Gy boost to the tumor bed or high-risk volumes. The primary endpoint is to assess acute toxicity of grade 2 or higher within 12 weeks post-treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Biopsy proven ipsilateral supraclavicular, infraclavicular or internal mammary nodal involvement.
2. Concurrent or previous neuropathy overlapping with the radiation volume or brachial plexus injury;
3. Patients who had radiotherapy to the ipsilateral breast, lymph-drainage regions or adjacent areas before;
4. Concurrent active connective tissue disease;
5. 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);
6. 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).
7. Pregnant or breast-feeding.

Where it's running

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

Study contacts

• Study coordinator: Shu-Lian Wang, M.D.
• Email: wangsl@cicams.ac.cn
• Phone: 8610-87788290

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing axillary radiotherapy and lymphadenectomy in breast cancer patients after neoadjuvant therapy

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• Comparing 1-week versus 2-week radiotherapy for high-risk breast cancer patients

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• Gyrotonic exercise for elders with breast cancer and Behcet disease

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.