Clinical trial · Interventional
Personalized Second Chance Breast Conservation (PSCBC): A Prospective Phase II Clinical Study
Personalized Second Chance Breast Conservation (PSCBC): A Two Center Prospective Phase II Clinical Study
- 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 goal of the study is to investigate the feasibility of enabling a second chance for breast conservation in patients with in-breast recurrences after a previous lumpectomy and RT, investigators propose to test partial breast irradiation with the target volume encompassing the entire surgical bed with 1.0-1.5 cm margins. An additional goal of the study is to investigate the feasibility of enabling a second chance for breast conservation in patients with inbreast recurrences after a previous lumpectomy and PBI, the investigators propose to test whole breast RT (WBRT) with the target as the whole breast volume.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 270cGy x 15 fractions WBRT | Radiation | — | UNRESOLVED |
| 600cGY x 5 fractions APBI | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Radiation Therapy - PBI
- description
- Patients will be treated with the fractionation of 30 Gy in 5 fractions over 1-2 weeks, which is the accelerated partial breast irradiation (PBI) fractionation scheme of choice for RT naïve patients at New York Presbyterian using External Beam Radiation Therapy (EBRT)
- interventionNames
- Radiation: 600cGY x 5 fractions APBI
- type
- OTHER
- label
- Radiation Therapy - WBRT
- description
- Patients will be treated with the fractionation of 4050 cGy in 15 fractions over 3 weeks, which is the standard whole breast RT (WBRT) fractionation scheme of choice for RT naïve patients at New York Presbyterian using External Beam Radiation Therapy (EBRT)
- interventionNames
- Radiation: 270cGy x 15 fractions WBRT
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * Isolated ipsilateral unifocal breast lesions * Limited size (\< 2-3 cm) without evidence of skin involvement * Histologically proven invasive breast carcinoma or carcinoma in situ * Negative histologic margins of resection * Patients with 0 to 3 positive axillary lymph nodes without extracapsular extension * No synchronous distant metastases * Age ≥ 18 years * ≥ 12 months interval between initial breast conserving therapy (surgery and whole breast radiotherapy) and recurrence * Previous WBI or IORT, brachytherapy or external beam partial breast treatment * Technical feasibility * Every kind of systemic therapy is allowed * Informed consent for clinical and research purposes signed Exclusion Criteria: * Regional recurrences (axillary, supraclavicular) * Positive histologic margins at resection * Metastatic disease * Poor cosmesis from previous surgery and RT * Extensive Intraductal Component
References
Publications (0)
Data not yet available