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

Launched by THOMAS JEFFERSON UNIVERSITY · Jul 8, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating whether reducing calorie intake while undergoing a specific type of radiation therapy called stereotactic ablative radiation therapy (sABR) can help shrink breast tumors before surgery. This study is particularly focused on patients with early-stage breast cancer, including conditions like ductal carcinoma in situ (DCIS) and invasive breast cancer. By combining calorie restriction with this targeted radiation treatment, researchers hope to see if it leads to better control of the tumor and reduces the risk of cancer spreading to other areas of the body.

To be eligible for the trial, participants must be at least 40 years old (or 50 if they have triple-negative breast cancer), have a body mass index (BMI) of 21 or higher, and have a tumor that is 3 cm or smaller. They should also be able to understand and follow the study requirements, including the dietary changes. Participants can expect to receive focused radiation treatment along with guidance on calorie restriction, and their progress will be monitored throughout the study. This trial is currently recruiting participants, and it's open to people who speak either English or Spanish.

Gender

ALL

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