Breast Cancer Clinical Trial
CAREFOR: Precision Medicine Driving Precision Nutrition for the Treatment of NeoAdjuvant Breast Cancer
Summary
The purpose of the study is to determine if a targeted dietary change can enhance the effect of neo-adjuvant chemotherapy
Full Description
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.
Eligibility Criteria
Inclusion Criteria:
Pathologically proven invasive breast cancer
Planned neoadjuvant chemotherapy determined by the judgment of the medical oncologist
The patient must be female
Age ≥ 18
Non-metastatic and non-inflammatory breast cancer
History/physical examination, including breast exam and documentation of weight and Karnofsky Performance Status of 80-100% for at least 60 days prior to study entry.
Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during chemotherapy
Patient must capable of and provide study specific informed consent prior to study entry
BMI ≥21
Weight ≥120lbs
No prior history of non-breast malignancies in the past 1 year unless it was a non- melanomatous skin lesion or carcinoma in situ of the cervix.
Patient must not have Acquired Immune Deficiency Syndrome (AIDS) or HIV positive based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS or HIV from this protocol is necessary because anti-retrovirals may alter patient metabolism.
Patient may not have any active Gastrointestinal/Malabsorption disorder at the discretion of the Principal Investigator which may include:
Chronic Pancreatitis
Chronic Diarrhea or Vomiting
Active Eating Disorder
No history of or current active drug/alcohol dependence.
No patients with decisional impairment.
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:
Chronic Diarrhea or Vomiting
Active Eating Disorder
Active drug/alcohol dependence or abuse history.
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There is 1 Location for this study
Philadelphia Pennsylvania, 19107, United States
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