Caloric restriction combined with targeted radiation therapy 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
This study is testing if cutting calories while getting targeted radiation therapy can help reduce tumor size more in people with early stage breast cancer compared to just the radiation alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT04959474 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of caloric restriction during pre-operative stereotactic ablative radiation therapy (sABR) on patients with early stage breast cancer. The study aims to determine if combining dietary restrictions with sABR can lead to a greater reduction in tumor size compared to sABR alone. Participants will be monitored for changes in tumor characteristics, pathologic complete response rates, and surgical outcomes. The trial also evaluates patient-reported health outcomes and satisfaction with treatment.
Who should consider this trial
Good fit: Ideal candidates include patients aged 40 and older with pathologically proven early stage breast cancer and a body mass index of 21 or higher.
Not a fit: Patients with advanced breast cancer or those requiring preoperative chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance tumor control and improve surgical outcomes for patients with early stage breast cancer.
How similar studies have performed: While the combination of caloric restriction and radiation therapy is a novel approach, similar studies have shown promising results in other cancer types.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Philadelphia, Pennsylvania
- Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Nicole Simone, MD — Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Study coordinator: Nicole Simone, MD
- Email: Nicole.Simone@jefferson.edu
- Phone: 215-955-8874
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.