Breast Cancer
Conditions
Keywords
breast cancer, hypofractionated partial breast irradiation
Brief summary
The study was designed to evaluate the feasibility and safety of hypofractionated partial breast irradiation after breast-conserving surgery for low-risk breast cancer patients.
Detailed description
A total dose of 40.05Gy in 15 fractions was delivered to the tumor bed for each eligible breast cancer patients. The endpoints including loco-regional recurrence, cosmetic outcomes, and toxicities, were evaluated after treatment.
Interventions
RADIATIONhypofractionated partial breast irradiation
deliver 40Gy/15Fx to tumor bed areas
Sponsors
Fudan University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Female * Age≥ 50 years * Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection * Negative surgical margins * Pathologically confirmed invasive breast cancer * A pathological T1N0M0 tumor -IHC: ER+/PR+/HER2- * Tumor bed is labeled with Titanium clips * Received adjuvant hormonal treatment * No adjuvant chemotherapy * ECOG:0-1 * Written informed consent.
Exclusion criteria
* Age\<50 years * KPS\<70 * Treated with neoadjuvant chemotherapy * Treated or being treated with chemotherapy * With severe comorbidity * Previous breast cancer or other malignant tumor history * Previous radiotherapy for breast or thorax * Medical contraindication for radiotherapy * Pregnant or nursing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of breast cosmetic outcome | Baseline, and three years after the completion of radiation therapy | The breast cosmetic outcome was measured by Harvard 4 scale (poor, moderate, good, excellent) evaluation system |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late complications | 3 years | Complications related to radiation treatment after more than 3 months. |
| Ipsilateral breast tumor recurrence rate | 5 years | The pathological confirmed tumor recurrence in the same breast |
| Acute radiation-induced toxicity assessed by CTCAE v4.0 | 3weeks, 5weeks,1 and 3 months after treatment beginning | acute toxicity related to skin and lung |
| Disease free survival | 5 years | The interval from diagnosis to disease recurrence or death or last visit. |
| Overall survival | 5 years | The interval from diagnosis to death or last visit |
| Local-regional recurrence | 5 years | Disease recurrence in the ipsilateral chest wall or axillary, supraclavicular or infraclavicular fossa, or internal mammary chain. |
Countries
China
Outcome results
None listed