Clinical trial · Interventional
Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer
Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer: A Phase I Feasibility/Pilot Study
NCT00694577CI-TRIAL-00062170completedN/AResults postedClinicalTrials.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)
The purpose of this study is to determine the feasibility of partial breast irradiation in participants with early invasive or non-invasive breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Breast Cancer | Breast Ductal Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Partial Breast Irradiation using 32 Gy / 8 fractions | Radiation | — | UNRESOLVED |
| Partial Breast Irradiation using 36 Gy / 9 fractions | Radiation | — | UNRESOLVED |
| Partial Breast Irradiation using 40 Gy /10 fractions | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Irradiation using 32 Gy / 8 fractions
- description
- Study Participants 1-100 Partial Breast Irradiation using 32 Gy / 8 fractions BID in one week
- interventionNames
- Radiation: Partial Breast Irradiation using 32 Gy / 8 fractions
- Radiation: Partial Breast Irradiation using 36 Gy / 9 fractions
- Radiation: Partial Breast Irradiation using 40 Gy /10 fractions
- type
- EXPERIMENTAL
- label
- Irradiation using 36 Gy / 9 fractions
- description
- Study Participants 101-200 Partial Breast Irradiation using 36 Gy / 9 fractions BID in one week
- interventionNames
- Radiation: Partial Breast Irradiation using 32 Gy / 8 fractions
- Radiation: Partial Breast Irradiation using 36 Gy / 9 fractions
- Radiation: Partial Breast Irradiation using 40 Gy /10 fractions
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed unicentric Stage I Invasive Ductal breast cancer. Histologically negative tumor margin 2mm or more from any inked edges, or no tumor in re-excision specimen or final shaved specimen. * Patient may have been treated with adjuvant chemotherapy, or be on adjuvant hormonal therapy or begin hormonal therapy following XRT * 18 years of age or older * ECOG Performance Status 0 * Required laboratory data as outlined in the protocol Exclusion Criteria: * Multicentric IDC of the breast defined as discontiguous tumors separated by at least 5cm of uninvolved tissue * Multifocal IDC of the breast, defined as discontiguous discrete foci of invasive carcinoma, separated by uninvolved intervening tissue, but within an overall span of 5cm, or within the same breast quadrant or subareolar central region * Tumor \> 2.0cm, nodal involvement, or metastatic involvement * Histological evidence of: lymphovascular invasion; blood vessel invasion; extensive intraductal component; invasive lobular carcinoma and infiltrating carcinoma of mixed ductal and lobular type; DCIS with microinvasion and DCIS suspicious for microinvasion; infiltrating micropapillary carcinoma * Known mutation carrier, including BRCA1 and BRCA2 * History of cosmetic or reconstructive breast surgery * Psychiatric illness which would prevent the patient from giving informed consent * Medical conditions such as uncontrolled infection, uncontrolled diabetes mellitus or connective tissue disease * Participants with a "currently active" second malignancy other than non-melanoma skin cancers * Patients with diffuse (\> 1 quadrant or \>5cm) suspicious microcalcifications * Women who are pregnant
References
Publications (2)
- DERIVEDPashtan IM, Recht A, Ancukiewicz M, Brachtel E, Abi-Raad RF, D'Alessandro HA, Levy A, Wo JY, Hirsch AE, Kachnic LA, Goldberg S, Specht M, Gadd M, Smith BL, Powell SN, Taghian AG. External beam accelerated partial-breast irradiation using 32 gy in 8 twice-daily fractions: 5-year results of a prospective study. Int J Radiat Oncol Biol Phys. 2012 Nov 1;84(3):e271-7. doi: 10.1016/j.ijrobp.2012.04.019. Epub 2012 May 30. PMID 22652104
- DERIVEDRecht A, Ancukiewicz M, Alm El-Din MA, Lu XQ, Martin C, Berman SM, Hirsch AE, Kachnic LA, Katz A, MacDonald S, Nedea EA, Stevenson MA, Powell SN, Taghian AG. Lung dose-volume parameters and the risk of pneumonitis for patients treated with accelerated partial-breast irradiation using three-dimensional conformal radiotherapy. J Clin Oncol. 2009 Aug 20;27(24):3887-93. doi: 10.1200/JCO.2008.20.0121. Epub 2009 Jul 20. PMID 19620489