SABR-CaRe in Early Stage Breast Cancer

Invasive Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04959474
• Other study ID #: 20D.876
• Status: Recruiting
• Phase: Phase 2
• Start date: August 23, 2021
• Est. completion date: January 1, 2026

Study information

• Verified date: June 2023
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 1, 2026
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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 axillary staging including axillary ultrasound (US) that proves patient is clinically node negative
• 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

Related Conditions & MeSH terms

• Anatomic Stage 0 Breast Cancer AJCC v8
• Breast Carcinoma In Situ
• Breast Ductal Carcinoma in Situ
• Breast Neoplasms
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Ductal
• Carcinoma, Ductal, Breast
• Carcinoma, Intraductal, Noninfiltrating
• Invasive Breast Carcinoma
• Prognostic Stage 0 Breast Cancer AJCC v8
• Triple Negative Breast Carcinoma

Intervention

Other:
• Best Practice
Given standard dietary recommendations

Radiation:
• Stereotactic Body Radiation Therapy
Undergo SABR

Procedure:
• Sentinel Lymph Node Biopsy
Undergo sentinel lymph node biopsy

Other:
• Questionnaire Administration
Ancillary studies
• Quality-of-Life Assessment
Ancillary studies

Procedure:
• Resection
Undergo surgical resection

Other:
• Dietary Intervention
Undergo a caloric restriction diet

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4-12 weeks after biopsy