Palbociclib (CDK4/6 Inhibitor)
Treatment for Breast Cancer
Typical Dosage: 125 mg daily for 21 days, followed by 7 days off, in combination with endocrine therapy
Effectiveness
65%
Safety Score
45%
Clinical Trials
74
Participants
15K
Comparative Safety Scale(Higher is safer)
Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
45
DangerousModerateSafe
Treatment Details
Dosage Range
125 mg daily for 21 days, followed by 7 days off, in combination with endocrine therapy
Time to Effect
Weeks to months
Treatment Duration
Until disease progression or unacceptable toxicity
Evidence Quality
HIGHNumber Needed to Harm (NNH)
5(Treat 5 patients to see 1 additional serious adverse event)
Confidence Score
90%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$140,000
Monitoring:$5,000
Side Effect Mgmt:$3,000
Total Annual:$148,000
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
POORICER
$350,000/QALY
QALYs Gained
0.3
Outcome-Based Costs
Cost per Responder
$246,667
Cost per Remission
$740,000
Comparison vs Endocrine therapy alone
Cost Difference
+$120,000/year
More expensive
QALY Difference
+0.20 QALYs
Better outcomes
Dominance
No dominance
Palbociclib (CDK4/6 Inhibitor) Outcomes
for Breast Cancer
Efficacy Outcomes
Overall Effectiveness
+65%
Response Rate
+60%
Remission Rate
+20%
Common Side Effects
Neutropenia
+80%
Fatigue
+40%
Nausea
+25%
Diarrhea
+20%
Sources:
Active Clinical Trials
16 active trials recruiting for Palbociclib (CDK4/6 Inhibitor) in Breast Cancer
Discontinuation of CDK4/6 Inhibitors in Patients With Metastatic HR Positive, HER2 Negative Breast Cancer
NCT06207734RECRUITINGPHASE2
120 participants
INTERVENTIONAL
Berlin, Germany +12 more
Started: Jan 17, 2024
A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer
NCT06495164ACTIVE NOT RECRUITING
1 participants
OBSERVATIONAL
New York, United States
Started: Jun 24, 2024
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
NCT06790693RECRUITINGPHASE3
450 participants
INTERVENTIONAL
Burbank, United States +193 more
Started: Apr 9, 2025
Chemo-free in Older (≥65) Node-Positive ER+/HER2- Breast Cancer
NCT07005557NOT YET RECRUITINGPHASE3
1.24K participants
INTERVENTIONAL
Started: Jun 15, 2025
Iparomlimab and Tuvonralimab (QL1706) in Patients With HR-positive, HER2-negative Advanced Breast Cancer
NCT07180160RECRUITINGPHASE2
123 participants
INTERVENTIONAL
Shanghai, China
Started: Sep 25, 2025
A Randomized Study Comparing the Immune Modulation Effect of Ribociclib, Palbociclib, and Abemaciclib in ER+/HER2- EBC
NCT05766410RECRUITINGPHASE2
60 participants
INTERVENTIONAL
Taipei, Taiwan +1 more
Started: Sep 16, 2022
Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone (SONIA) Receptor Positive Advanced Breast Cancer
NCT03425838ACTIVE NOT RECRUITINGPHASE3
1.05K participants
INTERVENTIONAL
's-Hertogenbosch, Netherlands +71 more
Started: Nov 9, 2017
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic Disease
NCT06760637RECRUITINGPHASE3
1.02K participants
INTERVENTIONAL
Birmingham, United States +451 more
Started: Jan 6, 2025
A Study of LY4064809 With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
NCT07174336RECRUITINGPHASE3
920 participants
INTERVENTIONAL
Anchorage, United States +224 more
Started: Dec 22, 2025
Cyclin dEpendent Kinase in tRiple nEGatIVe brEast canceR - a "Window of Opportunity" Study
NCT05067530NOT YET RECRUITINGPHASE2
126 participants
INTERVENTIONAL
Poznan, Poland +5 more
Started: Jan 1, 2022
Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer
NCT06380751RECRUITINGPHASE3
500 participants
INTERVENTIONAL
Gilbert, United States +284 more
Started: Aug 1, 2024
Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression
NCT04920708RECRUITINGPHASE2
324 participants
INTERVENTIONAL
Cambridge, United Kingdom +17 more
Started: Dec 28, 2022
A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)
NCT06065748RECRUITINGPHASE3
1.05K participants
INTERVENTIONAL
Daphne, United States +350 more
Started: Dec 11, 2023
Safety and Efficacy of T-DXd vs. CDK4/6i-based ET as First-line Therapy of HR-positive and HER2-low/Ultralow Advanced Breast Cancer Patients Classified as Non-luminal Subtype
NCT06486883RECRUITINGPHASE2
200 participants
INTERVENTIONAL
Genova, Italy +28 more
Started: Jun 30, 2025
The Efficacy and Safety of CDK4/6 Inhibitors in Combination with Endocrine Therapy in the Neoadjuvant Treatment
NCT06810492NOT YET RECRUITINGNA
40 participants
INTERVENTIONAL
Started: Apr 1, 2025
A Study of the Gut Microbiome in Hormone Receptor-positive HER2-negative Breast Cancer Treated With CDK4/6 Inhibitors
NCT06171360RECRUITING
100 participants
OBSERVATIONAL
Brussels, Belgium +2 more
Started: Nov 15, 2022
Completed Clinical Trials
2 completed trials for Palbociclib (CDK4/6 Inhibitor) in Breast Cancer
CDK4/6-inhibitor or Chemotherapy, in Combination with ENDOcrine Therapy, for Advanced Breast Cancer / KENDO
NCT03227328COMPLETEDPHASE2
52 participants
INTERVENTIONAL
Bologna, Italy +19 more
Started: Aug 2, 2017
European Treatment Patterns and Outcomes Associated With First-Line CDK4/6 Inhibition and Hormonal Therapies
NCT05043506COMPLETED
1.94K participants
OBSERVATIONAL
Braunau am Inn, Austria +63 more
Started: Feb 8, 2022
Showing 20 of 74 total trials