Breast cancer
Conditions
Interventions
WBRT group:hypofractionated whole breast radiotherapy in 2 weeks.
Sponsors
Beijing cancer hospital
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1: Female patients aged 18-70 years 2: ECOG 0-1 3: Received breast-conserving surgery (local enlarged excision of the mass + axillary lymph node dissection or biopsy pathologically confirmed invasive breast cancer or ductal carcinoma in situ of the sentinel lymph node) 4: pTis-T2, pN0 or pN1 patients without high-risk factors (high-risk factors include: young age, negative HR, extensive lymphovascular space involvement, primary site in the medial/central quadrant, high grade histology). if patients with invasive carcinoma did not receive axillary lymph node dissection, sentinel lymph node biopsy was needed to confirm metastasis-free, i.e. pN0(sn) 5: patients with ductal carcinoma in situ may not receive sentinel lymph node biopsy or axillary lymph node dissection 6: no distant metastasis 7: Negative surgical margins 8: Patients can tolerate chemotherapy, targeted therapy, endocrine therapy (if needed) and radiotherapy 9: For patients who did not require postoperative adjuvant chemotherapy, the start date of radiotherapy is required to be no more than 12 weeks from the date of surgery. Radiotherapy can be delivered concurrently with trastuzumab/pertuzumab and or endocrine therapy 10: For patients requiring post-operative adjuvant chemotherapy, the start date of radiotherapy is required to be no more than 8 weeks from the date of the last chemotherapy course. Radiotherapy can be delivered concurrently with trastuzumab/pertuzumab and or endocrine therapy 11: Willingness and ability to receive and be followed up regularly during and after treatment 12: Written informed consent signed by the patient.
Exclusion criteria
Exclusion criteria: 1: Regional node irradiation is indicated 2: Prior history of breast cancer, including ductal carcinoma in situ 3: Bilateral breast cancer 4: Receiving concurrent chemotherapy, antibody-drug conjugate or other medicine that may cause interruption of radiotherapy 5: Pregnancy or lactation 6: Pre-existing or simultaneous malignancies other than melanotic skin cancer or carcinoma in situ of the cervix 7: Active collagen vascular disease 8: Severe disease that cannot tolerate radiotherapy and subsequent treatment 9: Alcohol, drug or mental illness that may interfere the completion of treatment 10: Inability or unwillingness to sign an informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| grade 2 or higher acute radiotherapy-related toxicities; | — |
Secondary
| Measure | Time frame |
|---|---|
| late radiotherapy-related toxicities;change in photographic breast appearance.;cosmetic and functional outcomes;quality of life;local reccurence;regional recurrence;distant metastasis;overall survival;Disease free survival; | — |
Countries
China
Contacts
Public ContactTie, Jian
Beijing cancer hospital
Outcome results
None listed