Clinical trial · Interventional
Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer
SABR-CaRe: A Phase II Randomized Trial of Pre-Operative Stereotactic Ablative Radiation Therapy (SABR) With and Without Caloric Restriction for Early Stage Breast Cancer
- 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)
This phase II trial studies the effect of calorie reduction while undergoing stereotactic ablative radiation therapy in treating patients with breast cancer. Stereotactic ablative radiation therapy (sABR) is a highly focused radiation treatment that gives an intense dose of radiation concentrated on a tumor, while limiting the dose to the surrounding organ. Giving SABR before surgery may make the tumor smaller. Adding dietary restrictions in combination with radiation therapy may help increase local control and decrease the spread of the cancer to other places in the body. The purpose of this trial is to identify if there is a decrease in tumor tissue in patients undergoing caloric restriction during pre-operative SABR, compared to patients undergoing pre-operative SABR alone.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage 0 Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage 1 Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage 2 Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage 3 Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Breast Ductal Carcinoma in Situ | Breast Ductal Carcinoma In Situ | ONTOLOGY_EXACT | 0.98 |
| Invasive Breast Carcinoma | Invasive Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Triple Negative Breast Carcinoma | Triple-Negative Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Dietary Intervention | Other | — | UNRESOLVED |
| Mammography | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Resection | Procedure | — | UNRESOLVED |
| Sentinel Lymph Node Biopsy | Procedure | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (standard dietary recommendations, SABR, surgery)
- description
- Patients receive standard dietary recommendations. Patients undergo SABR every other day for 5 fractions. Within 4-12 weeks of completion of SABR, patients undergo surgical resection with sentinel lymph node biopsy.
- interventionNames
- Other: Best Practice
- Radiation: Stereotactic Body Radiation Therapy
- Procedure: Resection
- Procedure: Sentinel Lymph Node Biopsy
- Other: Questionnaire Administration
- Other: Quality-of-Life Assessment
- Procedure: Mammography
- Procedure: Biospecimen Collection
- type
- EXPERIMENTAL
- label
- Arm II (caloric restriction diet, SABR, surgery)
- description
- Beginning 1 week before the start of SABR, patients undergo a caloric restriction diet for 6-12 weeks (for the duration of radiation treatment, until post radiation follow-up appointment) consisting of reducing calorie intake by 25%. Patients undergo SABR every other day for 5 fractions. Within 4-12 weeks of completion of SABR, patients undergo surgical resection with sentinel lymph node biopsy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * • Patients with pathologically proven DCIS or invasive breast cancer histologies * Willing and able to provide informed consent * Willing and able to comply with study treatments including dietary intervention * Body mass index (BMI) \>= 21 at time of enrollment * Age \>= 40 years at time of consent \* Patients with triple negative breast cancer (TNBC) must be \>= 50 years of age at time of consent * Karnofsky performance status (KPS) score 70 - 100 * Tumor size =\< 3.0 cm * Gross disease within the breast must be unifocal \* Gross disease may be multifocal as long as the total extent of tumor, gross and microscopic, occupies a volume with greatest dimension =\< 3 cm * Patients with invasive disease are required to have clinical axillary staging including axillary ultrasound (US) that proves patient is clinically node negative or can be done by physical examination if the patient is over 70 * Patient is not being considered for preoperative chemotherapy * Must be English or Spanish speaking Exclusion Criteria: * Patient is clinically node positive: clinically suspicious axillary lymph node(s) by axillary US or exam unless biopsied and found to be negative * Patient has stage IV metastatic disease \* Patients with oligo-metastatic disease who are being treated with curative intent per the treating physician will not be excluded if all other eligibility criteria are met * Breast tumor size is \> 3.0 cm * Positive non-axillary sentinel nodes or evidence of suspicious supraclavicular, infraclavicular, or internal mammary nodes by imaging or physical exam, unless biopsied and found to be negative for tumor * Evidence by physical examination or mammography of other suspicious masses, densities, or microcalcifications in either breast, unless biopsied and found to be benign * Paget's disease of the nipple * Previous breast radiation on ipsilateral side * Any prior treatment with radiation therapy or chemotherapy for the current breast cancer diagnosis prior to registration * Patients with significant psychiatric illness that would preclude them from adhering to the protocol in the judgement of the treating clinician * BMI \< 21 at the time of study enrollment
References
Publications (0)
Data not yet available