Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer

NCT04959474 | Recruiting DMC

• 2 other identifiers: 20D.876JT 12711
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Anatomic Stage 0 Breast Cancer AJCC v8; Anatomic Stage 1 Breast Cancer AJCC v8; Anatomic Stage 2 Breast Cancer AJCC v8; Anatomic Stage 3 Breast Cancer AJCC v8; Breast Ductal Carcinoma in Situ; Invasive Breast Carcinoma; Triple Negative Breast Carcinoma

Outcome Measures

Primary Outcomes (1)

• Percent reduction in cellularity of breast tumor

  The mean percent reduction will be compared between the study arms using a two-sample two-sided t-test with alpha 0.05.

  4-16 weeks, depending on the date of surgery

Secondary Outcomes (7)

• Feasibility of identifying sentinel lymph node (SLN)

  After pre-operative SABR

• Global physiologic assessment

  Up to 6 months after SABR

• Change in patient-reported health-related quality of life

  Baseline to 6 months after SABR

• Physician cosmesis evaluation

  Up to 6 months after SABR

• Rate of positive margins and need for re-excision

  Up to 6 months after SABR

Study Arms (2)

Arm I (standard dietary recommendations, SABR, surgery)

ACTIVE COMPARATOR

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.

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

Arm II (caloric restriction diet, SABR, surgery)

EXPERIMENTAL

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.

Radiation: Stereotactic Body Radiation Therapy; Procedure: Resection; Procedure: Sentinel Lymph Node Biopsy; Other: Dietary Intervention; Other: Questionnaire Administration; Other: Quality-of-Life Assessment; Procedure: Mammography; Procedure: Biospecimen Collection

Interventions

Biospecimen Collection PROCEDURE

Undergo blood, tissue, and rectal swab sample collection

Also known as: Biological Sample Collection, Biological Sample Collection, Biospecimen Collected, Biospecimen Collection, Specimen Collection

Arm I (standard dietary recommendations, SABR, surgery); Arm II (caloric restriction diet, SABR, surgery)

Best Practice OTHER

Given standard dietary recommendations

Also known as: best practice, standard of care, standard of care, standard therapy

Arm I (standard dietary recommendations, SABR, surgery)

Stereotactic Body Radiation Therapy RADIATION

Undergo SABR

Also known as: SABR, SBRT, SBRT, Stereotactic Ablative Body Radiation Therapy, stereotactic body radiation therapy

Arm I (standard dietary recommendations, SABR, surgery); Arm II (caloric restriction diet, SABR, surgery)

Resection PROCEDURE

Undergo surgical resection

Also known as: Resection, resection, Surgical Resection, SURGICAL RESECTION, Surgical Resection, Surgical Resection, Surgical Resection

Arm I (standard dietary recommendations, SABR, surgery); Arm II (caloric restriction diet, SABR, surgery)

Sentinel Lymph Node Biopsy PROCEDURE

Undergo sentinel lymph node biopsy

Also known as: SENTINEL LYMPH NODE BIOPSY, sentinel lymph node biopsy, Sentinel Node Biopsy, Sentinel node biopsy alone, SLNB, SNB

Arm I (standard dietary recommendations, SABR, surgery); Arm II (caloric restriction diet, SABR, surgery)

Dietary Intervention OTHER

Undergo a caloric restriction diet

Also known as: Dietary Modification, intervention, dietary, Nutrition Intervention, Nutrition Interventions, Nutritional Interventions

Arm II (caloric restriction diet, SABR, surgery)

Questionnaire Administration OTHER

Ancillary studies

Arm I (standard dietary recommendations, SABR, surgery); Arm II (caloric restriction diet, SABR, surgery)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (standard dietary recommendations, SABR, surgery); Arm II (caloric restriction diet, SABR, surgery)

Mammography PROCEDURE

Undergo mammography

Also known as: Mammography, MAMMOGRAPHY, mammography, MG

Arm I (standard dietary recommendations, SABR, surgery); Arm II (caloric restriction diet, SABR, surgery)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Breast Carcinoma In Situ; Carcinoma, Intraductal, Noninfiltrating; Triple Negative Breast Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care; Radiosurgery; Sentinel Lymph Node Biopsy; Diet Therapy; Methods; Diet; Specimen Handling

Condition Hierarchy (Ancestors)

Carcinoma in Situ; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Adenocarcinoma; Neoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Lymph Node Excision; Nutrition Therapy; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Nicole Simone, MD

  Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Simone, MD

CONTACT

215-955-8874; Nicole.Simone@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: July 13, 2021
• Study Start: August 23, 2021
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

US (1)