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New treatment option for Anatomic Stage 0 Breast Cancer AJCC v8
Official title Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer
ClinicalTrials.gov ID: NCT04959474
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 and older
You may be able to join 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
You likely can't join 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...
- 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...
- Evidence by physical examination or mammography of other suspicious masses, densities, or microcalcifications in either breast, unless biopsied and...
- Paget's disease of the nipple
See the full eligibility 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...
- Patient is not being considered for preoperative chemotherapy
- Must be English or Spanish speaking
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.