Clinical trial · Interventional
Randomized Trial of Accelerated Partial Breast Irradiation
A Phase II Randomized Clinical Trial of Accelerated Partial Breast Irradiation Compared With Whole Breast Irradiation With IMRT in Early Breast Cancer
NCT03583619CI-TRIAL-00101669completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is to compare radiation toxicity of accelerated partial breast irradiation (ABPI) with whole breast irradiation (WBI) in low-risk breast cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Recurrence, Local | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| APBI | Radiation | — | UNRESOLVED |
| WBI | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- APBI
- description
- Patients receive accelerated partial breast irradiation to tumour bed to a total dose of 40Gy, 4.0Gy per fraction, 5 fractions a week, within 2 weeks.
- interventionNames
- Radiation: APBI
- type
- ACTIVE_COMPARATOR
- label
- WBI
- description
- Patients receive whole breast irradiation to a total dose of 43.5Gy, at 2.9Gy per fraction, 5 fractions a week, within 3 weeks.
- interventionNames
- Radiation: WBI
Primary outcomes (1)
- measure
- Number o participants with Grade 2 or more toxicity
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Life Expectation: \> 5 years * Enrollment date no more than 12 weeks after breast-conserving surgery or no more than 8 weeks after adjuvant chemotherapy * Histologically confirmed diagnosis of invasive ductal carcinoma (grade 1-2), or mucinous carcinoma, or papillary carcinoma, or tubular carcinoma, or medullary carcinoma: primary tumor ≤ 3.0cm in maximum diameter and pN0; or histologically confirmed DCIS: primary tumor ≤ 2.5cm in maximum diameter, low-medium grade * Unifocal tumour (confirmed by diagnostic MRI) * No lymphovascular invasion * ER positive (defined as medium-strongly nuclear staining in \>1% of the cancer cells) * Negative radial resection margins of \>= 2 mm * Surgical clips placed in the tumor bed * Written informed consent. Exclusion Criteria: * Stage Ⅱ-Ⅲ * Multifocal tumors * Histologically confirmed diagnosis of invasive ductal carcinoma (grade 3), - - - invasive micropapillary carcinoma, carcinoma of lobular in situ, invasive - - - lobular carcinoma * Paget's disease of the nipple * Underwent oncoplastic surgery of ipsilateral breast * Underwent neoadjuvant chemotherapy or hormonal therapy * Previous or simultaneous contralateral breast cancer * Undergone ipsilateral chest wall radiotherapy * Active collagen vascular disease.
References
Publications (1)
- DERIVEDSong YC, Sun GY, Fang H, Tang Y, Song YW, Hu C, Qi SN, Chen B, Jing H, Tang Y, Jin J, Liu YP, Lu NN, Li YX, Wang SL. Quality of Life After Partial or Whole-Breast Irradiation in Breast-Conserving Therapy for Low-Risk Breast Cancer: 1-Year Results of a Phase 2 Randomized Controlled Trial. Front Oncol. 2021 Sep 15;11:738318. doi: 10.3389/fonc.2021.738318. eCollection 2021. PMID 34604082