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New treatment option for Metastatic Breast Cancer
Official title The CDK4/6 Inhibitor Dosing Knowledge (CDK) Study
ClinicalTrials.gov ID: NCT06377852
What this study is testing
What is Palbociclib 125mg?
Palbociclib 125mg is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for metastatic breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- Hormone receptor positive (HR+) HER2 negative metastatic breast cancer. Cut-off values for positive/negative staining should be as per standard...
- Candidate for planned endocrine therapy in combination with 1st use of palbociclib or ribociclib, in the metastatic setting. The planned endocrine...
- Aged 65 years or older
- Adequate bone marrow and organ function. Laboratory values must be within normal institutional limits, or within ranges as indicated below, or...
- Absolute neutrophil count ≥ 1,000/µL
You likely can't join if
- Previous treatment with a CDK4/6 inhibitor for metastatic breast cancer, or previous treatment within the past 12 months with a CDK4/6 inhibitor in...
- Received greater than 30 days (in the metastatic setting) of the specific endocrine therapy agent planned as partner to the CDK4/6 inhibitor in the...
- Known history of intolerance or allergy to the planned agents used in this trial.
- Uncontrolled intercurrent illness that, as evaluated by the treating clinician, would hinder compliance with study requirements.
- Concurrent therapy with other investigational agents.
- Rapidly progressive brain metastases.
See the full eligibility criteria
- Hormone receptor positive (HR+) HER2 negative metastatic breast cancer. Cut-off values for positive/negative staining should be as per standard practice in accordance with ASCO/CAP (American Society of Clinical...
- Candidate for planned endocrine therapy in combination with 1st use of palbociclib or ribociclib, in the metastatic setting. The planned endocrine partner can be an aromatase inhibitor (letrozole, anastrozole...
- Aged 65 years or older
- Adequate bone marrow and organ function. Laboratory values must be within normal institutional limits, or within ranges as indicated below, or demonstrate minor abnormalities that are deemed clinically non-significant...
- Absolute neutrophil count ≥ 1,000/µL
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (participants with documented Gilbert's disease are allowed total bilirubin up to 5X ULN)
- AST (SGOT)/ALT (SGPT) \<3 x institutional ULN, or ≤ 5 x ULN for people with documented metastatic disease to the liver.
- Baseline QTc ≤ 480 ms (only for ribociclib patients)
- Ability to understand and the willingness to provide informed consent. Note: Remote consent is allowed per institutional guidelines.
- Previous treatment with a CDK4/6 inhibitor for metastatic breast cancer, or previous treatment within the past 12 months with a CDK4/6 inhibitor in the neo/adjuvant breast cancer setting.
- Received greater than 30 days (in the metastatic setting) of the specific endocrine therapy agent planned as partner to the CDK4/6 inhibitor in the study at the time of randomization.
- Known history of intolerance or allergy to the planned agents used in this trial.
- Uncontrolled intercurrent illness that, as evaluated by the treating clinician, would hinder compliance with study requirements.
- Concurrent therapy with other investigational agents.
- Rapidly progressive brain metastases.
- Active or chronic Hepatitis B or C are eligible provided they meet liver function laboratory criteria and are not on medication with a known interaction with the study agents.
- Current use of drugs that have known potential to prolong the QT interval (e.g., antiarrhythmic drugs), for patients on ribociclib. Note: If concomitant use cannot be avoided, monitor ECG when initiating, during...
- Prior or concurrent malignancies that are undergoing active treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Gilbert, Arizona, United States
- Glendale, Arizona, United States
- Goodyear, Arizona, United States
- Mesa, Arizona, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- Highlands Ranch, Colorado, United States
- Derby, Connecticut, United States
- Fairfield, Connecticut, United States
- Glastonbury, Connecticut, United States
- Greenwich, Connecticut, United States
- Guilford, Connecticut, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- North Haven, Connecticut, United States
- Torrington, Connecticut, United States
- Trumbull, Connecticut, United States
+ 43 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Gilbert, Arizona, United States; Glendale, Arizona, United States; Goodyear, Arizona, United States; Mesa, Arizona, United States; Phoenix, Arizona, United States and 57 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.