CAREFOR: Precision Medicine Driving Precision Nutrition for the Treatment of NeoAdjuvant Breast Cancer

NCT02827370 | Completed DMC

• 2 other identifiers: 16D.067JT 8562
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to determine if a targeted dietary change can enhance the effect of neo-adjuvant chemotherapy

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (7)

• Number of study participants who receive the dietary intervention to the historical controls

  Up to 24 months

• Weight changes

  Up to 24 months

• Change in insulin

  Up to 24 months

• Change in serum

  Up to 24 months

• Distant metastases

  Up to 24 months

Study Arms (1)

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.

Behavioral: Behavioral Dietary Intervention

Interventions

Behavioral Dietary Intervention BEHAVIORAL

Receive dietary counseling

Precision Nutrition (dietary intervention)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sidney Kimmel Cancer Center at Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy

Philadelphia, Pennsylvania, 19107, United States

Location

Related Links

• Thomas Jefferson University Hospital

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nicole Simone, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2016
• First Posted: July 11, 2016
• Study Start: June 16, 2016
• Primary Completion: July 1, 2019
• Study Completion: December 15, 2019
• Last Updated: April 29, 2025

Record last verified: 2025-04

Locations

US (1)