Clinical trial · Interventional
Study of Preoperative Boost Radiotherapy
A Phase II Study of Preoperative Boost Radiotherapy in Patients With Breast With Biomarker Analysis
NCT02482389CI-TRIAL-00057787terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): lack of enrollment
Summary
Brief summary (as posted)
This protocol seeks to utilize a novel method of tumor bed boost delivery and to better understand breast cancer radiation response through the analysis of pre-and post-radiation breast tumor samples.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Single fraction of 7 Gy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single arm 7 Gray (Gy) fraction of radiotherapy
- description
- All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery.
- interventionNames
- Radiation: Single fraction of 7 Gy
Primary outcomes (1)
- measure
- Change in Cosmesis Evaluations Using the NRG Oncology Cosmesis Scale
- timeFrame
- baseline to 3 years post radiation therapy
- description
- Change from baseline rates of cosmesis at 3 years post-treatment as measured by the NRG Oncology cosmesis scale. The scale is scored from 1 (excellent) to 4 (poor) with a lower number representing better physical appearance.
Secondary outcomes (3)
- measure
- Change Circulating Cell Free DNA to Identify Potential Radiation Response Biomarkers
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast. Biopsy tissue (either slides or block) from outside institutions will be reviewed to confirm diagnosis. 2. Breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric disease preventing resection through a single incision, no pregnant women, and no comorbid conditions precluding surgery) 3. cTis-T3 cancer judged to benefit (by treating radiation oncologist) from a tumor bed boost 4. Women of child-bearing potential must consent to use adequate contraception during the course of the study: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (IUD). Contraceptive measures such as Plan B (TM), sold for emergency use after unprotected sex, are not acceptable methods for routine use. 5. White blood cell (WBC) \> 3000, Hgb \> 10, platelets \>100000 within 30 days of consent 6. Eligible for contrasted magnetic resonance imaging( MRI) on initial evaluation with glomerular filtration rate (GFR) ≥ 60 ml/min. A diagnostic MRI ordered within 60 days of diagnosis will be considered an acceptable alternative and will not be repeated. 7. Outside breast imaging will be reviewed at Duke to confirm that findings are consistent with trial eligibility Exclusion Criteria: 1. Breast implant in the breast to be treated (contralateral breast implant is acceptable) 2. Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma) 3. Subjects unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach for at least 1 hour 4. Positive serum pregnancy test 5. Insufficient breast imaging to judge clinical stage 6. Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement. 7. Subjects in whom treatment planning constraints cannot be met
References
Publications (0)
Data not yet available
No reference posted for this study.