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

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ClinicalTrials.gov Identifier: NCT03697577
Recruitment Status : Recruiting
First Posted : October 5, 2018
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Jesus Anampa Mesias, Montefiore Medical Center

Brief Summary:
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).

Condition or disease Intervention/treatment
Breast Cancer Diagnostic Test: CT scans Diagnostic Test: DEXA scan

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Pilot Study Assessing the Effect of Cyclin-dependent Kinase 4/6 Inhibitors on Body Composition in Patients With ER+/HER2- Metastatic Breast Cancer
Actual Study Start Date : January 8, 2019
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort Intervention/treatment
ER+/HER2- metastatic breast cancer
Subjects have metastatic ER+/HER2- breast cancer, and their doctor is offering treatment with CDK 4/6 inhibitors as standard of care treatment.We hypothesize that cyclin-dependent kinase (CDK) 4/6 inhibitors decrease fat mass among women with ER+/HER2- metastatic breast cancer without significant effect in the skeletal mass. Body composition will be obtained from CT scans (CT or PETCT) as part of their standard of care, and body fat mass will be obtained from DEXA scan(as part of proposed study)
Diagnostic Test: CT scans
Patients will undergo CT or PETCT as part of their standard of care

Diagnostic Test: DEXA scan
Patients will undergo DEXA scan to measure body fat mass. This is part of proposed study.




Primary Outcome Measures :
  1. Total adipose tissue (TAT) [ Time Frame: 24 months ]
    Total Adipose tissue (TAT) is defined as the sum of intramuscular adipose tissue (IMAT), visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT) obtained from L3 cross section from CT scans.


Secondary Outcome Measures :
  1. Body fat mass (BFM) [ Time Frame: 24 months ]
    body fat mass will be obtained from dual-energy x-ray absorptiometry (DEXA).

  2. body lean mass(BLM) [ Time Frame: 24 months ]
    body lean mass(BLM) will be obtained from dual-energy x-ray absorptiometry (DEXA).

  3. Skeletal muscle index (SMI) [ Time Frame: 24 months ]
    Skeletal muscle index (SMI) is defined as muscle area at L3 cross section from CT scans in cm2 divided by height in meters squared

  4. glucose [ Time Frame: 24 months ]
    serum glucose will be measured

  5. waist-to-hip ratio [ Time Frame: 24 months ]
    waist-to-hip ratio will be measured with measuring tape.


Biospecimen Retention:   Samples With DNA
Total Number of Specimens 60 Project/Storage Duration : 24 MONTHS Sample Type :BLOOD-SERUM Specimen Volume :15CC Sample Preservation Measures : STANDARD


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who are being asked to participate in this study because they have metastatic ER+/HER2- breast cancer, and their doctor is offering treatment with CDK 4/6 inhibitors as standard of care treatment.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03697577


Contacts
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Contact: Jesus Anampa, MD 718-405-8505 janampa@montefiore.org
Contact: Karen Fehn, RN 718-405-8404 kfehn@montefiore.org

Locations
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United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Jesus D Anampa, MD,MS    718-405-8505    janampa@montefiore.org   
Contact: Karen Fehn, RN    7184058505    kfehn@montefiore.org   
Principal Investigator: Jesus Anampa, MD         
Sub-Investigator: Joseph Sparano, MD         
Sponsors and Collaborators
Montefiore Medical Center
Investigators
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Principal Investigator: Jesus Anampa, MD Montefiore Medical Center
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Responsible Party: Jesus Anampa Mesias, MD, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT03697577    
Other Study ID Numbers: 2018-9567
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jesus Anampa Mesias, Montefiore Medical Center:
cyclin-dependent kinase (CDK) 4/6 inhibitors
Body composition
body fat mass
metastatic ER+/HER2- breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases