Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| preoperative tumor-bed boost | Experimental | The participants receive preoperative tumor-bed boost, oncoplastic surgery and adjuvant WBRT±RNI. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Preoperative MRI-guided tumor-bed boost and postopreative ultra-hypofractionated radiotherapy (26 Gy/5.2Gy/5) | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The 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. | until 4 weeks of postoperative radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Local recurrence rate | The incidence of recurrence of any invasive or non-invasive breast cancer in the ipsilateral breast. | Until 5 years after diagnosis. |
| Local regional recurrence rate | The incidence of recurrence in the ipsilateral breast or the lymphatic nodal regions. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Dong, M.D. | Contact | +861087787678 | howelu1349@hotmail.com | |
| Hao Jing, M.D. | Contact | +861087788281 | owletskim@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jing Wang, M.D. | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Study Chair |
| Shu-lian Wang, M.D. | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College | Recruiting | Beijing | Beijing Municipality | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39264581 | Derived | Dong H, Jing H, Wang XY, Kong XY, Wang YP, Zhai YR, Che SN, Fang Y, Wang SL, Wang J. Exploring the feasibility of preoperative tumor-bed boost, oncoplastic surgery, and adjuvant radiotherapy schedule in early-stage breast cancer: a phase II clinical trial. Int J Surg. 2025 Jan 1;111(1):382-393. doi: 10.1097/JS9.0000000000002073. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Until 5 years after diagnosis. |
| Disease-free survival | The time interval from diagnosis to any event of recurrence or death. | Until 5 years after diagnosis. |
| Overall survival | The time interval from diagnosis to death from any reason. | 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. | 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. | 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. | Until 5 years after treatment. |
| Cosmetic outcome Breast Cancer Treatment Outcome Scale (BCTOS) | Until 5 years after treatment. |
| Cosmetic outcome Body Image Scale (BIS) | Until 5 years after treatment. |
| Hao Jing, M.D. | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Principal Investigator |
| Xiang-yi Kong, M.D. | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Study Director |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided