Hypofractionated Vs Conventional Fractionated Postmastectomy Radiotherapy for High Risk Breast Cancer

Recruiting now · Not applicable

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT03856372

Run by

Fudan University

People needed

1494

Starts

2018-09-01

Expected to finish

2028-10-30

Last updated by the study team

2019-02-27

Who can join

Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (enrolling)
• Suzhou Municipal hospital — Suzhou, Jiangsu, China
• Huangpu Branch, Shanghai ninth people's hospital — Shanghai, Shanghai Municipality, China

Full record on ClinicalTrials.gov

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