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Hypofractionated Vs Conventional Fractionated Postmastectomy Radiotherapy for High Risk Breast Cancer

CompletedNA

Sponsor: Fudan University

Conditions: Breast Cancer

Interventions: Hypofractionated, Conventional

Countries: China

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 overview

Sex: FEMALE

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (3)

Suzhou, Jiangsu, China
Shanghai, Shanghai Municipality, China
Shanghai, Shanghai Municipality, China