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| ID | Type | Description | Link |
|---|---|---|---|
| JT 8562 | Other Identifier | JeffTrial Number |
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The purpose of the study is to determine if a targeted dietary change can enhance the effect of neo-adjuvant chemotherapy
Primary objective:
I To determine if dietary alternations designed to downregulate the dominate molecular drivers of an individuals' breast cancer will enhance the effect of neoadjuvant chemotherapy and allow for an increase in the pathologic complete response rate.
Secondary objectives
I) Investigator measurable changes to molecular and patient characteristics from precision nutrition to determine a metric for evaluation this treatment in future studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precision Nutrition (dietary intervention) | Experimental | During chemotherapy, patients will receive dietary counseling based on the molecular pathways driving their specific breast cancers found through genetic testing. Nutritional recommendations will seek to down-regulate the dominant molecular drivers of an individual's breast cancer while they are receiving standard chemotherapy as outlined by their treating medical oncologist. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Dietary Intervention | Behavioral | Receive dietary counseling |
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| Measure | Description | Time Frame |
|---|---|---|
| Pathologic complete response assessed in tissue | The portion of patients who adhere to the diet restriction will be computed along with a 95% exact confidence. An exact binomial test (with a onesided alpha of 0.05) will also be used to test whether adherence is greater than 60%. | At time of definitive breast surgery |
| Incidence of adverse events evaluated by CTCAE version 4.0 | Up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of study participants who receive the dietary intervention to the historical controls | Will be compared to historical controls. Will be based on logistic regression, which will control for patient characteristics and clinical factors. The study has 81% power to detect an odds ratio of about 0.25 using a 2-sided alpha of 0.05 | Up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
Patient is male.
Age <18 years
Clinical stage IV cancer
Inflammatory breast cancer (T4d)
Women of childbearing potential with a positive serum beta hCG.
Decision impaired patients.
BMI < 21
Weight < 120lbs
Weight loss ≥10% in the last 3 mos
Prior invasive non-breast malignancy (except non-melanomatous skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 1 year prior to registration
Non-epithelial breast malignancies such as sarcoma or lymphoma
Active Gastrointestinal/Malabsorption disorder at the discretion of the Principal -Investigator which may include:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole Simone, MD | Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy | Philadelphia | Pennsylvania | 19107 | United States |
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| Label | URL |
|---|---|
| Thomas Jefferson University Hospital | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Weight changes | Will be assessed by modeling body mass index as a function of time via mixed-effects regression. | Up to 24 months |
| Change in insulin | Will be assessed as a function of time via mixed-effects regression. | Up to 24 months |
| Change in serum | Will be assessed as a function of time via mixed-effects regression. | Up to 24 months |
| Distant metastases | Will be analyzed via the Kaplan-Meier method and the logrank test. | Up to 24 months |
| Progression-free survival | Kaplan-Meier curves will be generated and a log-rank value will be calculated. | Up to 24 months |
| Overall survival | Will be analyzed with the Kaplan-Meier method and Cox proportional hazards regression. | Up to 24 months |
| D017437 |
| Skin and Connective Tissue Diseases |