Clinical trial · Interventional
SABER Study for Selected Early Stage Breast Cancer
Phase I Study to Evaluate the Safety and Feasibility of Preoperative Ablative Breast Radiotherapy (SABER) for Selected Early Stage Breast Cancer
NCT04360330CI-TRIAL-00120298SABERrecruitingN/AClinicalTrials.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 find the most effective dose of radiation therapy to give to breast tumors in a shorter period of time, prior to standard partial mastectomy/axillary surgery.
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 |
| Early-stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Ablative Breast Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Preoperative SABER
- description
- * Experimental: Preoperative Stereotactic Ablative Breast Radiotherapy (SABER). Phase I study testing up to 4 dose levels. * Non-experimental: Participants will undergo standard partial mastectomy and axillary surgery as per discretion of treating physician 4 to 6 weeks (+ at most 1 week delay) after preoperative SABER is completed.
- interventionNames
- Radiation: Stereotactic Ablative Breast Radiotherapy
Primary outcomes (1)
- measure
- Recommended Phase 2 Dose (RP2D) of Pre-Operative SABER
- timeFrame
- Up to 13 Weeks
- description
- The recommended phase 2 dose (RP2D) of pre-operative SABER therapy will be established as the highest dose level tested for which no more than 1 out of 6 patients experience dose-limiting toxicity (DLT). Adverse Events (AEs) including DLTs will be evaluated by treating physician using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female, ≥ 50 years of age. 2. Oncotype or MammaPrint diagnosis results are required prior to the start of treatment 3. Histologically confirmed invasive breast cancer. 4. Clinical stage T1N0M0. 5. Receptor status: Estrogen-Receptor (ER)/Progesterone-Receptor (PR) positive and Human Epidermal Growth Factor Receptor 2 (HER2) negative. 6. Unifocal breast cancer. 7. Eastern Cooperative Oncology Group (ECOG) 0, 1. 8. Ability to undergo MRI. 9. Women of child-bearing potential (WOCBP) must agree to use adequate contraception or agree to undergo sexual abstinence prior to study entry and for the duration of study participation. WOCBP must have a negative serum or urine pregnancy test at time of enrollment. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. 10. Ability to understand the investigational nature, potential risks and benefits of the research study and willingness to sign the written informed consent and HIPAA document(s). Exclusion Criteria: 1. Patients without histologically confirmed invasive breast cancer. 2. Patients without Oncotype or MammaPrint diagnosis results at the start of treatment. 3. Patients with metastatic disease. 4. ECOG 2, 3, 4. 5. Patients that are unable to undergo MRI. 6. Prior history of radiation to the chest. 7. History of collagenous disease (systemic lupus erythematosus, scleroderma, dermatomyositis). 8. Any serious medical or psychiatric illness/condition likely in the judgment of the Investigator(s) to interfere or limit compliance with study requirements/treatment. 9. Diagnosis of another primary malignancy within the last 5 years with the exception of non-melanoma skin cancer. 10. Patients unable to consent, who are pregnant or nursing, or are prisoners.
References
Publications (0)
Data not yet available
No reference posted for this study.