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Home › Medications › palbociclib

palbociclib

7 published articles · Updated continuously

Clinical Trial Landscape

Clinical Trials of palbociclib

39 trials tracked of palbociclib: 6 in phase 3 or 4 and 4 with published results. The most-cited published study has 132 citations.

39Trials tracked
6Phase 3 & 4
0Recruiting
4With published results
Phase distribution
Phase 4 1 Phase 3 5 Phase 2 24 Phase 1 5 Other / NA 4
  1. Phase 3 Phase III Palbociclib With Endocrine Therapy vs. Capecitabine in HR+/HER2- MBC With Resistance to Aromatase Inhibitors Completed · 132 cited
  2. Phase 3 A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4] Completed · 74 cited
  3. Phase 3 Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3) Completed · 34 cited
  4. Phase 3 Palbociclib Plus Letrozole For Postmenopausal Women With HR(+) HER2(-) Advanced Breast Cancer For Whom Letrozole Is Deemed Appropriate Completed · 4 cited
  5. Phase 4 Palbociclib In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR+, HER2- Advanced Breast Cancer Completed
  6. Phase 3 Lung-MAP: Palbociclib as Second-Line Therapy in Treating Cell Cycle Gene Alteration Positive Patients With Recurrent Stage IV Squamous Cell Lung Cancer Completed
Show 33 more trials
  1. Phase 2 Palbociclib in Treating Patients With Relapsed or Refractory Rb Positive Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating Alterations in Cell Cycle Genes (A Pediatric MATCH Treatment Trial) Completed
  2. Phase 2 Palbociclib and Cetuximab in Metastatic Colorectal Cancer Completed
  3. Phase 2 Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis Completed
  4. Phase 2 Hydroxychloroquine, Palbociclib, and Letrozole Before Surgery in Treating Patients With Estrogen Receptor Positive, HER2 Negative Breast Cancer Completed
  5. Phase 2 Safety And Efficacy Study Of Palbociclib Plus Cetuximab Versus Cetuximab To Treat Head And Neck Cancer Completed
  6. Phase 2 Palbociclib in Combination With Adjuvant Endocrine Therapy for Hormone Receptor Positive, HER2 Negative Invasive Breast Cancer Completed
  7. Phase 2 A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer) Completed
  8. Phase 2 Palbociclib With Everolimus + Exemestane In BC Completed
  9. Phase 2 A Phase II Randomized Study Evaluating the Biological and Clinical Effects of the Combination of Palbociclib With Letrozole as Neoadjuvant Therapy in Post-Menopausal Women With Estrogen-Receptor Positive Primary Breast Cancer Completed
  10. Phase 2 A Study of Palbociclib in Combination With Fulvestrant or Tamoxifen as Treatment for Metastatic Breast Cancer Completed
  11. Phase 2 Phase II Trial Evaluating the Efficacy of Palbociclib in Combination With Carboplatin for the Treatment of Unresectable Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Completed
  12. Phase 2 A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer Completed
  13. Phase 2 T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer Completed
  14. Phase 2 Palbociclib in Molecularly Characterized ER-positive/HER2-negative Metastatic Breast Cancer Completed
  15. Phase 2 A Study of Neoadjuvant Nivolumab + Palbociclib + Anastrozole in Post-Menopausal Women and Men With Primary Breast Cancer Completed
  16. Phase 2 Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer Completed
  17. Phase 2 To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH) Completed
  18. Phase 2 Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer Completed
  19. Phase 2 A Study of Palbociclib in Combination With Bazedoxifene in Hormone Receptor Positive Breast Cancer Completed
  20. Phase 2 A Study of ZN-c5 in Subjects With Breast Cancer Completed
  21. Phase 2 Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer Completed
  22. Phase 2 Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer Completed
  23. Phase 2 Safety and Efficacy of PD0332991 (Palbociclib), a Cyclin-dependent Kinase 4 and 6 Inhibitor, in Patients With Oligodendroglioma or Recurrent Oligoastrocytoma Anaplastic With the Activity of the Protein RB Preserved Completed
  24. Phase 2 Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer Completed
  25. Phase 1 Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer Completed
  26. Phase 1 Dose-Escalation Study Of Palbociclib + Nab-Paclitaxel In mPDAC Completed
  27. Phase 1 Palbociclib in Combination With Chemotherapy in Treating Children With Relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL) Completed
  28. Phase 1 Palbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer Completed
  29. Phase 1 Treatment of Metastatic Breast Cancer With Fulvestrant Plus Palbociclib or Tamoxifen Plus Palbociclib Completed
  30. N/A Study to Compare Overall Survival in Medicare Patients With Metastatic Breast Cancer Treated With a Medicine Called Palbociclib in Combination With Aromatase Inhibitor and Aromatase Inhibitor by Itself. Completed
  31. N/A A Study to Understand the Treatment Patterns and Patients and Their Clinical Outcomes Who Are Taking Palbociclib in a Real Life Setting in Israel. Completed
  32. N/A UK Ibrance Patient Program (IPP) Study Completed
  33. N/A Lung-MAP: Biomarker-Targeted Second-Line Therapy in Treating Patients With Recurrent Stage IV Squamous Cell Lung Cancer Completed

Showing the 39 most-cited and recently-updated of 39 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
CDK4/6 inhibitors show therapeutic potential in advanced gastrointestinal cancers, review finds
Infectious Disease Sys. Review
CDK4/6 inhibitors show therapeutic potential in advanced gastrointestinal cancers, review finds CDK4/6 inhibitors show promise against digestive cancers
This narrative review examines the role of CDK4/6 inhibitors (palbociclib, ribociclib, abemaciclib) in advanced gastrointestinal cancers. It…
New review reveals how CDK4/6 drugs might work against stomach, colon, and liver cancers, but hurdles remain.
Frontiers Jun 5, 2026
Meta-analysis of CDK4/6 inhibitor rechallenge shows improved progression-free survival in advanced breast cancer
Oncology Meta-analysis
Meta-analysis of CDK4/6 inhibitor rechallenge shows improved progression-free survival in advanced breast cancer Switching drugs offers hope for advanced breast cancer patients facing treatment failure
This meta-analysis synthesizes data from phase II and III clinical trials involving 1396 patients with hormone receptor-positive, HER2-negat…
A large review found that restarting a specific cancer drug after stopping it can delay disease growth by nearly two months compared to stan…
May 28, 2026
CDK4/6 inhibitors plus endocrine therapy improve survival in advanced hormone receptor-positive breast cancer
Oncology Meta-analysis
CDK4/6 inhibitors plus endocrine therapy improve survival in advanced hormone receptor-positive breast cancer CDK4/6 Inhibitors Boost Survival In Advanced Breast Cancer
This meta-analysis of 11 phase 3 trials involving 6035 patients demonstrates that CDK4/6 inhibitors combined with endocrine therapy signific…
New data shows adding CDK4/6 inhibitors to hormone therapy helps patients live longer with advanced breast cancer.
May 1, 2026
CDK4/6i plus AI or fulvestrant shows similar clinical benefit in HR+ HER2- MBC
Drug Pipeline Cohort
CDK4/6i plus AI or fulvestrant shows similar clinical benefit in HR+ HER2- MBC Two drugs linked to longer survival than palbociclib in breast cancer
This retrospective single-center analysis of 341 patients with HR+/HER2− MBC found that palbociclib, abemaciclib, and dalpiciclib combined w…
In a real-world analysis, two CDK4/6 inhibitors showed longer survival times than palbociclib for metastatic breast cancer patients.
Frontiers Apr 24, 2026
FDA Approves Itovebi (Itovebi) for Endocrine-Resistant, PIK3CA-Mutated, HR-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
Oncology FDA Approval
FDA Approves Itovebi (Itovebi) for Endocrine-Resistant, PIK3CA-Mutated, HR-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer FDA approves new breast cancer drug Itovebi for a specific type of advanced cancer
The FDA approved Itovebi in combination with palbociclib and fulvestrant for adults with endocrine-resistant, PIK3CA-mutated, HR-positive, H…
A new oral drug, Itovebi, is now FDA-approved for advanced breast cancer with a specific genetic mutation, offering another option when horm…
FDA Apr 21, 2026
Gedatolisib plus fulvestrant with or without palbociclib improved progression-free survival versus fulvestrant monotherapy in advanced breast cancer
Oncology RCT
Gedatolisib plus fulvestrant with or without palbociclib improved progression-free survival versus fulvestrant monotherapy in advanced breast cancer New Drug Combo Slashes Breast Cancer Progression Risk by 75%
This phase III randomized trial evaluated gedatolisib plus fulvestrant with or without palbociclib in patients with hormone receptor-positiv…
For patients with tough-to-treat advanced breast cancer, a new three-drug combination nearly quadrupled the time before the cancer started g…
Apr 20, 2026
Sequential paclitaxel-palbociclib showed no difference in ORR versus reverse sequence in ER+/HER2- breast cancer
Oncology RCT
Sequential paclitaxel-palbociclib showed no difference in ORR versus reverse sequence in ER+/HER2- breast cancer New Test Predicts Who Needs Chemo in Breast Cancer
This randomized phase II trial evaluated sequential administration of paclitaxel and palbociclib with endocrine therapy in patients with ER+…
Doctors now have a way to spot patients who can skip chemo and go straight to safer hormone treatment.
Apr 12, 2026