Breast CarcinomaNCT02827370
CAREFOR: Precision Medicine Driving Precision Nutrition for the Treatment of NeoAdjuvant Breast Cancer
A study testing Behavioral Dietary Intervention in people with Breast Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
The purpose of the study is to determine if a targeted dietary change can enhance the effect of neo-adjuvant chemotherapy Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Behavioral Dietary Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2016to 15 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson Univeristy
Philadelphia, Pennsylvania, 19107
About this study
Official title: CAREFOR Study: Precision Nutrition Caloric Restriction for Oncology Research: Precision Medicine Driving Precision Nutrition During Neoadjuvant Chemotherapy for Breast Cancer
The purpose of the study is to determine if a targeted dietary change can enhance the effect of neo-adjuvant chemotherapy
Read the detailed 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
- Investigator measurable changes to molecular and patient characteristics from precision nutrition to determine a metric for evaluation this treatment in future studies.
- Conditions
- Breast Carcinoma
- Being tested
- Behavioral Dietary Intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Dietary InterventionBehavioural
Receive dietary counseling
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Behavioral Dietary Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: At time of definitive breast surgery
Incidence of adverse events evaluated by CTCAE version 4.0
Measured: Up to 24 months
Secondary outcomes (7)
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
Measured: Up to 24 months
Weight changes
Will be assessed by modeling body mass index as a function of time via mixed-effects regression.
Measured: Up to 24 months
Change in insulin
Will be assessed as a function of time via mixed-effects regression.
Measured: Up to 24 months
Change in serum
Will be assessed as a function of time via mixed-effects regression.
Measured: Up to 24 months
Distant metastases
Will be analyzed via the Kaplan-Meier method and the logrank test.
Measured: Up to 24 months
Progression-free survival
Kaplan-Meier curves will be generated and a log-rank value will be calculated.
Measured: Up to 24 months
Overall survival
Will be analyzed with the Kaplan-Meier method and Cox proportional hazards regression.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start16 Jun 2016
- Primary completion1 Jul 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Simone, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827370
- Sponsor's protocol ID
- 16D.067
- Other IDs
- JT 8562
- Status last verified
- Apr 2025
- First submitted
- 13 Jun 2016
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAREFOR Study: Precision Nutrition Caloric Restriction for Oncology Research: Precision Medicine Driving Precision Nutrition During Neoadjuvant Chemotherapy for Breast Cancer
- ClinicalTrials.gov ID
- NCT02827370
- Acronym / sponsor ID
- 16D.067
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 16 Jun 2016 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine if a targeted dietary change can enhance the effect of neo-adjuvant chemotherapy
Detailed 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
- Investigator measurable changes to molecular and patient characteristics from precision nutrition to determine a metric for evaluation this treatment in future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Precision Nutrition (dietary intervention) | Experimental | Behavioral: Behavioral Dietary InterventionDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (15 listed)
- Patient is male.
- Age <18 years
- Clinical stage IV cancer
- Inflammatory breast cancer (T4d)
- Women of childbearing potential with a positive serum beta hCG.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral Dietary InterventionReceive dietary counseling | Behavioural | Precision Nutrition (dietary intervention) |
Primary outcome
Pathologic complete response assessed in tissue
Time frame: At time of definitive breast surgery
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%.
Incidence of adverse events evaluated by CTCAE version 4.0
Time frame: Up to 24 months
7 secondary outcomes
Number of study participants who receive the dietary intervention to the historical controls
Time frame: Up to 24 months
Weight changes
Time frame: Up to 24 months
Change in insulin
Time frame: Up to 24 months
Change in serum
Time frame: Up to 24 months
Distant metastases
Time frame: Up to 24 months
Progression-free survival
Time frame: Up to 24 months
Overall survival
Time frame: Up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Thomas Jefferson University HospitalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Simone, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Dietary Intervention in people with Breast Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic complete response assessed in tissue (time frame: At time of definitive breast surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.