Clinical trial · Interventional
Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
- 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)
To determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity plus margin using IORT as a single dose, intracavitary brachytherapy with the MammoSite device over 5 days, partial breast 3-D CRT in 5 days, or stereotactic APBI over 4 days is a feasible and safe alternative to a six and a half week course of whole breast radiotherapy. The study will measure both short and long-term complications of radiation treatment, short and long-term breast cosmesis, local rates of in-breast cancer recurrence, regional recurrences, distant metastases, and overall survival.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Carcinoma, Ductal | Breast Ductal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Accelerated External Beam 3-D Conformal Radiotherapy | Radiation | — | UNRESOLVED |
| Intracavitary Brachytherapy | Radiation | — | UNRESOLVED |
| Intra-Operative Radiotherapy (IORT) | Radiation | — | UNRESOLVED |
| Lumpectomy | Procedure | — | UNRESOLVED |
| Stereotactic APBI | Radiation | — | UNRESOLVED |
| Whole Breast Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Accelerated Partial Breast Irradiation
- description
- lumpectomy with accelerated partial breast irradiation
- interventionNames
- Radiation: Intra-Operative Radiotherapy (IORT)
- Procedure: Lumpectomy
- Radiation: Intracavitary Brachytherapy
- Radiation: Accelerated External Beam 3-D Conformal Radiotherapy
- Radiation: Stereotactic APBI
- type
- ACTIVE_COMPARATOR
- label
- Standard Therapy
- description
- lumpectomy and whole breast irradiation
- interventionNames
- Procedure: Lumpectomy
- Radiation: Whole Breast Radiotherapy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women \>= 40 with invasive ductal carcinoma or ductal carcinoma in situ 2. Patient chooses lumpectomy rather than mastectomy as treatment for breast cancer 3. Tumor \< 2.5 cm in size, 2 mm margin of normal breast tissue between cancer and edge of specimen. Exclusion Criteria: 1. Men 2. Prior malignancy, breast or other if metastatic or with anticipated survival of \< 5 years 3. Pregnant women 4. Immunocompromised 5. Poorly controlled insulin dependent diabetes 6. Contraindication to radiotherapy, e.g. connective tissue disorder such as scleroderma 7. Breast cancer that involves skin or chest wall 8. Multifocal or Multicentric breast cancer 9. Invasive lobular carcinoma 10. Diffuse microcalcifications on mammography 11. Invasive carcinoma with extensive intraductal component (EIC) 12. Greater than 12 weeks since definitive surgical excision or completion of chemotherapy 13. Involved lymph nodes detected by frozen section or touch preparation at time of lumpectomy 14. Patients with 1 to 3 positive lymph nodes determined postoperatively (does not include patients with micro-metastases) 15. Subglandular or submuscular breast implants (does not include patients having implants placed AFTER intra-operative radiotherapy)
References
Publications (1)
- DERIVEDHorst KC, Fasola C, Ikeda D, Daniel B, Ognibene G, Goffinet DR, Dirbas FM. Five-year results of a prospective clinical trial investigating accelerated partial breast irradiation using 3D conformal radiotherapy after lumpectomy for early stage breast cancer. Breast. 2016 Aug;28:178-83. doi: 10.1016/j.breast.2016.06.001. Epub 2016 Jun 17. PMID 27322859