RecruitingNot ApplicableNCT03856372

Hypofractionated Vs Conventional Fractionated Postmastectomy Radiotherapy for High Risk Breast Cancer

Postmastectomy Hypofractionated Versus Conventional Fractionated Radiotherapy in High Risk Breast Cancer: a Phase III Randomized Clinical Trial

Sponsor

Fudan University

Enrollment

1,494 participants

Start Date

Sep 1, 2018

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

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

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Inclusion Criteria13

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 Criteria13

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