Pilot Study Assessing the Effect of Cyclin-dependent Kinase 4/6 Inhibitors on Body Composition in Patients With ER+/HER2- Metastatic Breast Cancer

  • End date
    Dec 1, 2023
  • participants needed
  • sponsor
    Montefiore Medical Center
Updated on 28 February 2022
stage iv breast cancer
breast adenocarcinoma
Accepts healthy volunteers


The goal of this study is to evaluate changes in body composition among patients who are treated with cyclin-dependent kinase (CDK) 4/6 inhibitors (abemaciclib, ribociclib, or palbociclib).


The goal of this study is to evaluate changes in body composition among patients who are treated with cyclin-dependent kinase (CDK) 4/6 inhibitors (abemaciclib, ribociclib, or palbociclib). There is preliminary data suggesting that these drugs have more effect on body fat mass than body muscle mass. These drugs have already been approved by U.S Food and Drug Administration (FDA) to treat ER+/HER2- metastatic breast cancer. The investigators will follow up body composition changes among patients who receive CDK 4/6 inhibitors as part of their standard of care. Body composition changes will be measured from CT or PET/CT scans that are part of standard of care treatment, and from DEXA scans (as part of proposed study). The investigators will also conduct body measurements with measuring tape, and will draw blood tests to assess for fat biomarkers.

Condition Breast Cancer
Treatment CT scans, Dexa Scan
Clinical Study IdentifierNCT03697577
SponsorMontefiore Medical Center
Last Modified on28 February 2022


Yes No Not Sure

Inclusion Criteria

Histologically confirmed adenocarcinoma of the breast that is ER and/or PR positive, Her2 negative based on current ASCO-CAP guidelines
Metastatic or locally advanced/inflammatory, unresectable breast cancer not amenable to potentially curative surgery
Measurable and/or non-measurable as defined by RECIST 1.1 criteria
Patients must be a candidate to start an FDA approved CDK 4/6 inhibitor (palbociclib, ribociclib, abemaciclib) as part of standard of care treatment
Female, or male patients, and age >18 years
ECOG performance status 0-2
Ability to understand and the willingness to sign a written informed consent document
At least 30 days from major surgery before study enrollment, with full surgical wound healing and return to baseline performance status
Concomitant therapy with bisphosphonates, RANKL inhibitors or growth-colony-stimulating factor (G-CSF) is allowed as per physician decision

Exclusion Criteria

History of allergic reactions attributed to compounds of similar chemical or biologic composition to CDK 4/6 inhibitors or other agents used in the study (e.g., fulvestrant, letrozole, anastrozole, exemestane)
BMI < 18.5
Prior CDK 4/6 use in any setting
Inability to undergo anthropometric measurements
Inability to undergo CT scan imaging
Recent radiation or chemotherapy within 4 weeks
Women of child-bearing potential must not be pregnant or breast feeding. They must also agree to use adequate contraception (hormonal or barrier method of birth control) and not be breast feeding prior to study entry, for the duration of study participation, and for up to 10 days after completion of all protocol therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study or up to 10 days after completion of protocol therapy, she should inform her treating physician immediately
Intercurrent illness that would substantially increase the risk of treatment associated complications (e.g., active infection, uncontrolled diabetes mellitus or hypertension)
Psychiatric illness/social situations that would interfere with the patient's ability to comply with the treatment regimen
Patients with untreated brain metastasis are excluded. Patients with a prior history of brain metastasis are eligible if they have received prior brain radiation (whole brain or stereotatactic radiosurgery) or surgery, have stable intracranial disease for at least 3 months after completion of local therapy, and are not taking corticosteroids for treatment of brain metastasis
Treatment with bevacizumab, other targeted therapies, or other investigational agents within the past 4 weeks
Patients who have not recovered (i.e., CTCAE Grade ≤1 or baseline) from an adverse event due to a previously administered agent, excluding alopecia
Patients with inability to swallow and retain pills
Malabsorption syndrome or other gastrointestinal illness that could affect oral absorption
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