Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06377852 · ClinicalTrials.gov registry record · Phase 3
The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study
A Phase 3 study of Metastatic Breast Cancer, sponsored by American Society of Clinical Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 500
- Enrollment target
- 20
- Study locations
NCT06377852 is a Phase 3 study of Metastatic Breast Cancer that is actively recruiting participants, run by American Society of Clinical Oncology. The registered enrollment target is 500 participants, above the 201-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (149% higher). The trial reports 20 study locations across 3 states.
The verdict
NCT06377852, a Phase 3 study of Metastatic Breast Cancer, is actively recruiting participants, sponsored by American Society of Clinical Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 500 participants
- Enrollment target
- 20
- Study locations
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 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 201-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (149% higher). The listed sponsor is American Society of Clinical Oncology, which has 2 total studies on file at ClinicalTrials.gov.
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.
NCT06377852 reports 20 study locations spanning 3 distinct geographic areas - top geographies include Connecticut, Arizona, Colorado.
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.
What interventions are being tested in trial NCT06377852?
The interventions under investigation include: Palbociclib (DRUG), Ribociclib (DRUG), Palbociclib 125mg (DRUG), Ribociclib 600mg (DRUG).
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.
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.
Learn More About Clinical Trials
Similar trials for Metastatic Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
RECRUITING · Phase 3
-
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
RECRUITING · Phase 3
-
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
RECRUITING · Phase 3
-
A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer
RECRUITING · Phase 3
-
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
RECRUITING · Phase 3
-
Study of the Bria-IMT Regimen and CPI vs Physicians' Choice in Advanced Metastatic Breast Cancer.
RECRUITING · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.