Evaluating body composition changes in breast cancer patients treated with CDK inhibitors
Pilot Study Assessing the Effect of Cyclin-dependent Kinase 4/6 Inhibitors on Body Composition in Patients With ER+/HER2- Metastatic Breast Cancer
This study is testing how certain cancer medications affect body fat and muscle mass in women with advanced breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Bronx, New York) |
| Trial ID | NCT03697577 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess changes in body composition among patients receiving cyclin-dependent kinase (CDK) 4/6 inhibitors, specifically abemaciclib, ribociclib, or palbociclib, for the treatment of ER+/HER2- metastatic breast cancer. The study will utilize CT or PET/CT scans, DEXA scans, and body measurements to evaluate the impact of these medications on body fat and muscle mass. Blood tests will also be conducted to analyze fat biomarkers. The findings may provide insights into the effects of CDK inhibitors on body composition during standard care.
Who should consider this trial
Good fit: Ideal candidates include adults with histologically confirmed ER+/HER2- metastatic breast cancer who are starting treatment with FDA-approved CDK 4/6 inhibitors.
Not a fit: Patients with a history of allergic reactions to CDK 4/6 inhibitors or those not eligible for these treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help optimize treatment strategies for breast cancer patients by understanding the impact of CDK inhibitors on body composition.
How similar studies have performed: Preliminary data suggests that similar studies have indicated a notable effect of CDK inhibitors on body fat mass, although this specific approach is less commonly explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the breast that is ER and/or PR positive 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 * 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 * 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 stereotactic 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 * 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 * Patients with active implanted medical devices (cardiac pacemakers, defibrillators or patients connected to electronic life support devices)
Where this trial is running
Bronx, New York
- Montefiore Medical Center — Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Jesus Anampa, MD — Montefiore Medical Center
- Study coordinator: Jesus Anampa, MD
- Email: janampa@montefiore.org
- Phone: 718-405-8505
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.