A Study of the Body's Response to Exercise and a Plant-Based Diet in Overweight Postmenopausal Women With Breast Cancer

Running, not enrolling · Phase 2

Conditions studied: Breast Cancer, Primary Hormone Receptor Positive Breast Cancer

In brief

The purpose of this study is to find out what effects, if any, exercise and a plant-based diet have on aromatase levels in postmenopausal women who are overweight and being treated with an aromatase inhibitor for their HR+ breast cancer. The study will also look at other ways diet and exercise may affect your body (for example, changing the way your breast tissue expresses or makes genes) and your quality of life.

Key facts

Study ID

NCT04298086

Run by

Memorial Sloan Kettering Cancer Center

People needed

43

Starts

2020-03-04

Expected to finish

2027-03-01

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Patients with histologically-confirmed, HR-positive (ER and/or PR) stage 1-3 breast cancer
• Completed anti-HER2 therapy, if HER2-positive
• Postmenopausal status defined by lack of menses for 2 years, oophorectomy, or medical ovarian suppression
• At least 3 months post completion of chemotherapy, if administered
• At least 3 months post radiation, if administered
• Receiving adjuvant endocrine therapy with an aromatase inhibitor (anastrozole, letrozole, exemestane)
• ECOG performance status of 0 to 1
• Sedentary (i.e.,performing <150 minutes / week of exercise structured moderate-intensity or strenuous-intensity)
• Age ≥ 18
• BMI ≥ 27
• Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria and in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator:
• Achieved a plateau in oxygen consumption, concurrent with an increase in power output
• A respiratory exchange ratio ≥ 1.10
• Attainment of maximal predicted heart rate (HRmax) (i.e., within10 bpm of age- predicted HRmax [HRmax= 220 - Age (years)]
• Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.
• Willingness to comply with all study-related procedures
• Intact breast available for biopsy

You may not qualify if…

• Presence of metastatic disease
• Any concurrent malignancy requiring active treatment with the exception of selective estrogen receptor modulators and aromatase inhibitors
• Insulin-dependent diabetes mellitus or non-insulin dependent diabetes mellitus on insulin therapy
• Enrollment onto any other interventional investigational study except interventions determined by the PI not to confound the effect of exercise or diet on study outcomes
• Mental impairment leading to inability to cooperate
• Any of the following contraindications to exercise:
• Acute myocardial infarction within 3-5 days of any planned study procedures;
• Unstable angina
• Uncontrolled arrhythmia causing symptoms or hemodynamic compromise
• Recurrent syncope
• Active endocarditis
• Acute myocarditis or pericarditis
• Symptomatic severe aortic stenosis
• Uncontrolled heart failure
• Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures
• Thrombosis of lower extremities
• Suspected dissecting aneurysm
• Uncontrolled asthma
• Pulmonary edema
• Respiratory failure
• Acute non-cardiopulmonary disorders that may affect exercise performance
• Any other condition or intercurrent illness that, in the opinion of the investigator, makes the subject a poor candidate for study participation.
• Nut or legume allergy
• Concurrent participation in weight loss programs

Where it is running

• Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States
• Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States
• Memorial Sloan Kettering Commack (Limited Protocol Activities) — Commack, New York, United States
• Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States

Full record on ClinicalTrials.gov

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