Clinical trial · Interventional
CAREFOR: Precision Medicine Driving Precision Nutrition for the Treatment of NeoAdjuvant Breast Cancer
CAREFOR Study: Precision Nutrition Caloric Restriction for Oncology Research: Precision Medicine Driving Precision Nutrition During Neoadjuvant Chemotherapy for Breast Cancer
NCT02827370CI-TRIAL-00089046completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of the study is to determine if a targeted dietary change can enhance the effect of neo-adjuvant chemotherapy
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behavioral Dietary Intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Precision Nutrition (dietary intervention)
- description
- 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.
- interventionNames
- Behavioral: Behavioral Dietary Intervention
Primary outcomes (2)
- measure
- Pathologic complete response assessed in tissue
- timeFrame
- At time of definitive breast surgery
- description
- 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%.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.