Metastatic Breast Cancer study: Palbociclib vs Ribociclib
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, taken by mouth once daily, 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 study wants to see if beginning with a lower dose lets patients stay on treatment longer than the standard dose. It also looks at side‑effects and other patient‑focused outcomes.
- Who it's for
- People age 60 or older who have hormone‑receptor‑positive, HER2‑negative metastatic breast cancer.
- What's involved
- Participants pick either palbociclib or ribociclib and an endocrine therapy, then are randomly assigned to the standard dose or a lower‑starting dose that can be increased if tolerated. They take the drug daily for 21 days of each 28‑day cycle and have regular clinic or telehealth visits and routine tests.
- Time commitment
- The study continues until the treatment is stopped, with visits each 28‑day cycle (in‑person or virtual) and occasional lab or imaging tests.
- 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 60 and older
You may be able to join if
- Hormone receptor positive (HR+) HER2 negative metastatic breast cancer.
- Candidate for planned endocrine therapy in combination with 1st use of palbociclib or ribociclib, in the metastatic setting.
- Aged 60 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 60 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 or anticancer therapy beyond aromatase inhibitors or fulvestrant.
- Rapidly progressive brain metastases. Note: only applies to patients with known brain metastases. Brain imaging not required for enrollment.
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.
- Aged 60 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 60 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 or anticancer therapy beyond aromatase inhibitors or fulvestrant. Note: radiation is allowed at any time.
- Rapidly progressive brain metastases. Note: only applies to patients with known brain metastases. Brain imaging not required for enrollment.
- 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.
- Prior or concurrent malignancies that are undergoing active treatment.
The study team makes the final eligibility decision.
Where it is enrolling
- 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
- Eureka, California, United States
- Santa Rosa, California, 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
+ 62 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, but 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, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at 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 76 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.