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SABR-CaRe in Early Stage Breast Cancer

Primary Purpose

Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage 1 Breast Cancer AJCC v8, Anatomic Stage 1A Breast Cancer AJCC v8

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Stereotactic Body Radiation Therapy
Sentinel Lymph Node Biopsy
Questionnaire Administration
Quality-of-Life Assessment
Resection
Dietary Intervention
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anatomic Stage 0 Breast Cancer AJCC v8

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson UniveristyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (standard dietary recommendations, SABR, surgery)

Arm II (caloric restriction diet, SABR, surgery)

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 27, 2021
Last Updated
June 28, 2023
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT04959474
Brief Title
SABR-CaRe in Early Stage Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 23, 2021 (Actual)
Primary Completion Date
November 1, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage 1 Breast Cancer AJCC v8, Anatomic Stage 1A Breast Cancer AJCC v8, Anatomic Stage 1B Breast Cancer AJCC v8, Anatomic Stage 2 Breast Cancer AJCC v8, Anatomic Stage 2A Breast Cancer AJCC v8, Anatomic Stage 2B Breast Cancer AJCC v8, Anatomic Stage 3 Breast Cancer AJCC v8, Anatomic Stage 3A Breast Cancer AJCC v8, Anatomic Stage 3B Breast Cancer AJCC v8, Anatomic Stage 3C Breast Cancer AJCC v8, Breast Ductal Carcinoma in Situ, Invasive Breast Carcinoma, Prognostic Stage 0 Breast Cancer AJCC v8, Prognostic Stage 1 Breast Cancer AJCC v8, Prognostic Stage 1A Breast Cancer AJCC v8, Prognostic Stage 1B Breast Cancer AJCC v8, Prognostic Stage 2 Breast Cancer AJCC v8, Prognostic Stage 2A Breast Cancer AJCC v8, Prognostic Stage 2B Breast Cancer AJCC v8, Prognostic Stage 3 Breast Cancer AJCC v8, Prognostic Stage 3A Breast Cancer AJCC v8, Prognostic Stage 3B Breast Cancer AJCC v8, Prognostic Stage 3C Breast Cancer AJCC v8, Triple Negative Breast Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (standard dietary recommendations, SABR, surgery)
Arm Type
Active Comparator
Arm 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.
Arm Title
Arm II (caloric restriction diet, SABR, surgery)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Best Practice
Intervention Description
Given standard dietary recommendations
Intervention Type
Radiation
Intervention Name(s)
Stereotactic Body Radiation Therapy
Intervention Description
Undergo SABR
Intervention Type
Procedure
Intervention Name(s)
Sentinel Lymph Node Biopsy
Intervention Description
Undergo sentinel lymph node biopsy
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
Resection
Intervention Description
Undergo surgical resection
Intervention Type
Other
Intervention Name(s)
Dietary Intervention
Intervention Description
Undergo a caloric restriction diet
Primary Outcome Measure Information:
Title
Percent reduction in cellularity of breast tumor
Description
The mean percent reduction will be compared between the study arms using a two-sample two-sided t-test with alpha 0.05.
Time Frame
4-12 weeks after biopsy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicole Simone, MD
Phone
215-955-6702
Email
Nicole.Simone@jefferson.edu

12. IPD Sharing Statement

Learn more about this trial

SABR-CaRe in Early Stage Breast Cancer

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