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The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study
NCT06377852 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to generate evidence on an alternative dosing strategy for CDK4/6 inhibitors to help more patients with Metastatic Breast Cancer (MBC) (age ≥ 65 years) tolerate side effects and stay on treatment longer, to derive the most clinical benefit from these drugs. The primary objective of the CDK Study is to compare time to treatment discontinuation (TTD) on the approved dosing for palbociclib (125 mg orally daily on days 1-21 of 28-day cycle) or ribociclib (600 mg orally daily on days 1-21 of 28-day cycle) vs. TTD using titrated dosing approach with the same schedule but starting at a lower dose of palbociclib (100 mg or 75 mg) or ribociclib (400 mg or 200 mg) and escalating the dose if well-tolerated in combination with provider/patient choice endocrine therapy (aromatase inhibitor (AI) or fulvestrant) in patients age 65 or older with HR+/HER2- MBC. The secondary and exploratory objectives will generate evidence needed to personalize treatment decisions by comparing patient-centric secondary outcomes and evaluating baseline factors. Together with their treating physician, participants will choose the CDK4/6 inhibitor (palbociclib or ribociclib) and which endocrine therapy (aromatase inhibitor or fulvestrant) of their choice but will be randomized to either Arm 1 (indicated dosing) or Arm 2 (titrated dosing). Note: Telehealth visits are allowed at any time per institutional guidelines. In addition, the study allows for remote consenting per institutional guidelines.
Conditions Studied
Interventions
- DRUG Palbociclib
- DRUG Ribociclib
- DRUG Palbociclib 125mg
- DRUG Ribociclib 600mg
Study Locations (20)
Connecticut
- Smilow Cancer Hospital Care Center - Derby — Derby
- Smilow Cancer Hospital Care Center - Fairfield — Fairfield
- Smilow Cancer Hospital at Glastonbury — Glastonbury
- Smilow Cancer Hospital Care Center - Greenwich — Greenwich
- Smilow Cancer Hospital Care Center - Guilford — Guilford
- Smilow Cancer Hospital at Saint Francis — Hartford
- Smilow Cancer Hospital - Yale New Haven Health — New Haven
- Yale University/Yale Cancer Center/Yale School of Medicine — New Haven
- Smilow Cancer Hospital Care Center - North Haven — North Haven
Arizona
- Ironwood Cancer & Research Centers — Chandler
- Ironwood Cancer & Research Centers — Gilbert
- Ironwood Cancer & Research Centers — Glendale
- Ironwood Cancer & Research Centers — Goodyear
- Ironwood Cancer & Research Centers — Mesa
- Ironwood Cancer & Research Centers — Mesa
- Ironwood Cancer & Research Centers — Phoenix
- Ironwood Cancer & Research Centers — Scottsdale
Colorado
- University of Colorado Anschutz Medical Campus — Aurora
- UCHealth Cherry Creek Medical Center — Denver
- UCHealth Highlands Ranch Hospital — Highlands Ranch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2024-10-29 |
| Est. Completion | 2028-09-01 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06377852
The ClinicalTrials.gov registry entry for NCT06377852 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is American Society of Clinical Oncology, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 4 interventions — of which Palbociclib is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06377852 reports 20 study locations spanning 3 distinct geographic areas — top geographies include Connecticut, Arizona, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06377852 about?
NCT06377852 is a clinical study titled "The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study". The purpose of this study is to generate evidence on an alternative dosing strategy for CDK4/6 inhibitors to help more patients with Metastatic Breast Cancer (MBC) (age ≥ 65 years) tolerate side effects and stay on treatment longer, to derive the most clinical benefit from these drugs. The primary ...
What is the current status of trial NCT06377852?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 500 participants. The study started on 2024-10-29. Estimated completion is 2028-09-01.
What conditions does trial NCT06377852 study?
This clinical trial studies the following conditions: Metastatic Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06377852?
The interventions under investigation include: Palbociclib (DRUG), Ribociclib (DRUG), Palbociclib 125mg (DRUG), Ribociclib 600mg (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06377852?
This trial is sponsored by American Society of Clinical Oncology, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06377852 being conducted?
This trial has 20 study locations across Arizona, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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