Actively Recruiting

Phase 2
Age: 35Years +
FEMALE
NCT05762900

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

Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2023-03-10

65

Participants Needed

1

Research Sites

417 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 35Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  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.
Not Eligible

You will not qualify if you...

  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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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, China, 100021

Actively Recruiting

Loading map...

Research Team

S

Shu-Lian Wang, 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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here