Hypofractionated Vs Conventional Fractionated Postmastectomy Radiotherapy for High Risk Breast Cancer

  • STATUS
    Recruiting
  • End date
    Oct 30, 2028
  • participants needed
    1494
  • sponsor
    Fudan University
Updated on 22 January 2021

Summary

The study was designed to investigate whether hypofractionated adjuvant radiotherapy is noninferior to conventionally fractionated adjuvant radiotherapy in terms of efficacy and toxicities for high risk breast cancer patients treated with mastectomy

Description

The randomization is between 50 Gy / 25 fractions and 42.5 Gy/16 fractions, 5 fractions weekly.

Eligible breast cancer patients with mastectomy and axillary dissection will be randomized 1:1 into two groups: conventional fractionated (CF) radiotherapy of 50 Gy / 25 fractions and hypofractionated (HF) radiotherapy of 42.5 Gy/16 fractions, 5 fractions weekly.

The primary endpoint is loco-regional recurrence. Other cancer related events and acute/late radiation morbidities will also be evaluated. The patients will be followed for 10 years.

It is hypothesized that for women operated for high risk breast cancer with indication of postmastectomy adjuvant radiotherapy, hypofractionated radiotherapy is noninferior to conventional fractionated radiotherapy in terms of the efficacy and toxicities.

Details
Condition Breast Cancer, Breast Cancer Diagnosis, breast carcinoma, cancer, breast
Treatment conventional, HYPOFRACTIONATED
Clinical Study IdentifierNCT03856372
SponsorFudan University
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Female
Age18-75 years
Pathologically confirmed invasive breast cancer
Treated with mastectomy and axillary lymph node dissection with more than 10 resected lymph nodes. Immediate or delayed ipsilateral breast cancer reconstruction is accepted
Negative surgical margins
Pathologic T1-2N1 with at least one of the following risk factors: <40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression, or pT3-4, or pN2-3 (four or more positive axillary lymph nodes)
No distant metastases
No supraclavicular or internal mammary nodes metastases
ECOG:0-1
Adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 treatment is accepted
No neoadjuvant chemotherapy
Fit for postoperative radiotherapy. No contraindications to radiotherapy
Signed informed consent

Exclusion Criteria

Concurrent or previous malignancy excluding basal or squamous cell carcinoma of the skin
Previous radiotherapy to the chest wall or regional lymph node areas
Patients with severe non-malignant comorbidity in cardiovascular or respiration system
Patients with medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis
pT1-2N1 with none of the following risk factors: <40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression
Patients with supraclavicular or internal mammary nodes metastases
Known definitive clinical or radiologic evidence of metastatic disease
Bilateral breast cancer or historically confirmed contralateral invasive breast cancer
Treated with neoadjuvant chemotherapy
ECOG: 3-4
Pregnant or lactating
Conditions indicating that the patient cannot go through the radiation therapy or follow up
Unable or unwilling to sign informed consent
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