Recruiting
Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving Surgery
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
ClinicalTrials.gov IDNCT04025164
PhaseNA
Enrollment4052
SponsorFudan University
Age18 Years
SexFEMALE
Conditions studied
Breast Cancer
About this study
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
Interventions
- Radiation: Hypofractionated Radiotherapy — daily fractions, 2.66 Gy/3.2 Gy per fraction to whole breast/tumor bed, five fractions per week
- Radiation: Conventional fractionated Radiotherapy — daily fractions, 2 Gy per fraction, five fractions per week
Primary outcomes
- Loco-regional recurrence (LRR) (5 years)
Eligibility information
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
Study locations
- Guizhou Provincial People's Hospital, Guiyang, Guizhou 550002 China
- Suzhou Municipal hospital, Suzhou, Jiangsu 215000 China
- The Second Hospital of Dalian Medical University, Dalian, Liaoning 116044 China
- Shanghai Huangpu District Central Hospital, Shanghai, Shanghai Municipality 200002 China
- Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality 200032 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.