NCT03697577Completed
CDK and Body Composition Study
Pilot Study Assessing the Effect of Cyclin-dependent Kinase 4/6 Inhibitors on Body Composition in Patients With ER+/HER2- Metastatic Breast Cancer
Source: ClinicalTrials.gov · Last updated 25 Sept 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 30 (actual)
- First submitted
- 2 Oct 2018
- Start date
- 8 Jan 2019
- Primary completion date
- 8 Jul 2026
- Lead sponsor
- Montefiore Medical Center
- Diseases
- Metastatic breast cancer
- NCT number
- NCT03697577
What you commit to
- Study type: Observational
- Participants enrolled: 30
- From 8 Jan 2019 to the primary completion date, 8 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior CDK 4/6 use in any setting
- 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
- 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
Other illness
- 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)
- 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
- 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)
Other
- BMI \< 18.5
- Inability to undergo anthropometric measurements
- Inability to undergo CT scan imaging
- Patients with inability to swallow and retain pills
Who the study is looking for
- Histologically confirmed adenocarcinoma of the breast that is Estrogen Receptor (ER) and/or Progesterone Receptor (PR) positive based on current American Society of Clinical Oncology-College of American Pathologists (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
- Eastern Cooperative Oncology Group (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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Montefiore Medical Center Coordinator of this site? Confirm its status | The Bronx | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.