Clinical trial · Interventional
Radiation Therapy Before Surgery in Treating Patients With Hormone Receptor Positive, HER2 Negative Breast Cancer
PRECISE: Preoperative Radiotherapy to Elicit Critical Immune Stimulating Effects
NCT03359954CI-TRIAL-00104693active not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
This phase II trial studies how well radiation therapy before surgery works in treating patients with hormone receptor positive, HER2 negative breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Estrogen Receptor Positive | — | UNRESOLVED | — |
| HER2/Neu Negative | — | UNRESOLVED | — |
| Invasive Breast Carcinoma | Invasive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Progesterone Receptor Positive | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy | Radiation | — | UNRESOLVED |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (radiation therapy, surgery)
- description
- Patients undergo boost radiation therapy 6-8 days before breast surgery. After surgery, patients continue to receive standard of care radiation therapy.
- interventionNames
- Radiation: Radiation Therapy
- Procedure: Therapeutic Conventional Surgery
Primary outcomes (1)
- measure
- Evaluation of Change in Percent of Tumor-Infiltrating Lymphocytes (TIL)
- timeFrame
- 6 to 8 days after preoperative radiotherapy
- description
- With 20 patients, a 95% confidence interval for the mean difference between TIL measurements would extend 0.44\*s units from the mean (where "s" is the standard deviation of the TIL differences). If the differences are not normally distributed, researchers will report the median difference along with appropriate 95% confidence intervals. Appropriate graphs used to visualize the data.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Inclusion: * Age \>/=18 years at time of study entry * Histologically confirmed HR+/HER2- (according to American Society of Clinical Oncology/College of American Pathologists guidelines) invasive carcinoma of the breast * Presence of a clip in the primary breast cancer * Biopsy-amenable residual disease in the breast measuring \>/= 1cm in at least one dimension on ultrasound cm in at least one dimension on ultrasound * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Signed written informed consent * Planned for multidisciplinary evaluation by a Breast Surgical Oncologist and Breast Radiation Oncologist. For patients undergoing mastectomy and desirous of reconstruction or those undergoing breast conservation in whom oncoplastic local tissue rearrangement or reduction mammoplasty is being considered, this multidisciplinary evaluation will also include a plastic surgeon. Exclusion: * Women who are pregnant or breast-feeding * Contraindication to receive radiotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.