This study explores the feasibility of preoperative single-dose tumor-bed boost followed by oncoplastic breast-conserving surgery and ultra-hypofractionated postoperative radiotherapy in patients with early stage breast cancer. Patients less than 55 years old, who are diagnosed with breast cancer and are eligible to recieve breast-conserving surgery are enrolled. Patients who are older than 55 years, with suspected regional lymph node metastasis are excluded. The primary end point are the acute toxicities within 4 weeks after adjuvant radiation. The secondary endpoints are oncologic outcomes, surgical complications within 30 days, late toxicities, patients' quality of life and cosmetic outcomes.
This is a prospective, non-controlled, feasitility study. The tumor-bed boost part of the radiotherpay is put forward, 7-14 days before the definitive surgery. A single dose of 10Gy is prescribed to the tumor bed. In order to identify the tumor accurately, MRI guided radiotherapy is applied under the MR-linac. The breast surgery is planned after recovery from radiation induced acute toxicity, within 14 days. The surgeons would undertake lumpectomy only or an additional oncoplastic surgery, with axillary nodal evaluation with sentinal nodal biopsy or dissection. After wound healing, postoperative whole breast radiotherapy is administered, within 6 weeks following surgery. The dose is 26Gy/5.2Gy/5 fractions. Adjuvant systemic therapy is held until the end of the radiotherapy, no more than 12 weeks from surgery implementation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
102
Preoperative tumor-bed boost was performed under MRI Linac, and a single dose of 10Gy is prescribed. The postoperative radiotherapy of 26Gy/5.2Gy/5 fractions is within 6 weeks following surgery. Adjuvant chemotherapy, targeted therapy and endocrine therapy are initiated no more than 12 weeks after surgery.
National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
RECRUITINGThe rate of patients who develop radiation-associated acute toxicity (≥ 2 degree)
We will record the incidence of ≥ 2 degree radiation-associated acute toxicity, such as breast or chest wall oedema, acute dermatitis, breast pain,itch of breast skin. The incidence of all the above is the primary outcome.
Time frame: until 4 weeks of postoperative radiotherapy
Local recurrence rate
The incidence of recurrence of any invasive or non-invasive breast cancer in the ipsilateral breast.
Time frame: Until 5 years after diagnosis.
Local regional recurrence rate
The incidence of recurrence in the ipsilateral breast or the lymphatic nodal regions.
Time frame: Until 5 years after diagnosis.
Disease-free survival
The time interval from diagnosis to any event of recurrence or death.
Time frame: Until 5 years after diagnosis.
Overall survival
The time interval from diagnosis to death from any reason.
Time frame: Until 5 years after diagnosis.
Complications of surgery in the short term.
We will record the incidence of surgery assciated mobilidy events within 30 days, including bleeding, seroma, hematoma, wound dehiscence, flap necrosis, delayed wound healing, fat necrosis, wound infection, abscess and upper limb edema.
Time frame: Until 30 days after the surgery.
Quality of Life (according the outcomes of questionnaires to evaluate the quality of life) EORTC QLQ-C30
European Organization Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire EORTC QLQ-C30 to record patients' quality of life in different time points.
Time frame: Until 5 years after treatment.
Quality of Life (according the outcomes of questionnaires to evaluate the quality of life) EORTC BR-23
European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire EORTC BR-23 to record patients' quality of life in different time points.
Time frame: Until 5 years after treatment.
Cosmetic outcome Breast Cancer Treatment Outcome Scale (BCTOS)
Time frame: Until 5 years after treatment.
Cosmetic outcome Body Image Scale (BIS)
Time frame: Until 5 years after treatment.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.