Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving Surgery

Summary

The study was designed to investigate whether hypofractionated radiotherapy(HF-RT) is noninferior to conventionally fractionated radiotherapy (CF-RT) in terms of tumor loco-regional control for patients after breast conserving surgery

Eligibility

Inclusion Criteria:

* Female
* Age18-70 years
* Imaging examination confirmed single lesion. if the tumor is multiple, it needs to be removed by single quadrantectomy
* Receive breast conserving surgery with negative margins
* Axillary lymph nodes treatment: Sentinel lymph node biopsy or level I/II axillary lymph node dissection. If the sentinel lymph node is negative, the axillary lymph node dissection can be omitted. If it is positive, level I/II axillary lymph node dissection with or more than 10 lymph nodes is needed.
* The tumor bed is labeled with clips and it can be drawn on the treatment planning system.
* Pathologically confirmed invasive breast cancer
* Pathologically stage is T1-3N0-3M0
* Immunohistochemical examination is conducted to determine the status of ER, PR, HER2, Ki67 after surgery
* No distant metastases
* No supraclavicular or internal mammary nodes metastases
* No neoadjuvant chemotherapy
* Fit for postoperative radiotherapy. No contraindications to radiotherapy
* KPS≥80
* Signed informed consent

Exclusion Criteria:

* T4 or M1 breast cancer
* Supraclavicular or internal mammary nodes metastases
* Pathologically confirmed DCIS only without an invasive component
* Bilateral breast cancer or historically confirmed contralateral invasive breast cancer
* Treated with neoadjuvant chemotherapy or neoadjuvant endocrine therapy
* Multiple lesions can not be removed by single quadrantectomy
* Suspicious unresected and microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast)
* KPS ≤ 70
* Patients with severe non-malignant comorbidity in cardiovascular or respiration system
* 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 medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis
* Pregnant or lactating
* Conditions indicating that the patient cannot go through the radiation therapy or follow up
* Unable or unwilling to sign informed consent

Conditions2

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