Maintained by Sreepriya Prasannan

MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist

Compiled from ClinicalTrials.gov registry records · Last verified 24 Sep 2026 · Editorial standards

Palbociclib is named as a drug or biological intervention in 41 clinical trials in our USA, China, UK, India and Ireland trial registers, 17 of which are recruiting. Lead sponsors include Hoffmann-La Roche (7), Pfizer (6) and AstraZeneca (5). Registered phases: Phase 3, Phase 1/2, Phase 1, Phase 2, Observational, Phase 2/3 and Not applicable. Conditions studied include Breast Cancer; Metastatic Breast Cancer; Advanced Solid Tumors.

Palbociclib also has an approved-drug profile on this site (FDA label data): Ibrance (Palbociclib) →

Clinical trials of Palbociclib

41 trials

NCT ID	Study	Phase	Status	Lead sponsor	Register
NCT06380751	Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, 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 (ClinicalTrials.gov ↗) Advanced Breast Cancer	Phase 3	Recruiting	AstraZeneca	UK, USA, India, China
NCT06757634	Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) Breast Cancer	Phase 3	Recruiting	Celcuity Inc	USA, China
NCT07174336	A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) Breast Neoplasms, Neoplasm Metastasis	Phase 3	Recruiting	Eli Lilly and Company	Ireland, UK, USA, China
NCT07492641	BGB-43395 Plus Letrozole Versus CDK4/6i Plus Letrozole for Patients With Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Treatment for Advanced or Metastatic Disease (ClinicalTrials.gov ↗) HR+/HER2- Breast Cancer	Phase 3	Recruiting	BeOne Medicines	UK, USA, China
NCT04606446	Study of PF-07248144 in Advanced or Metastatic Solid Tumors (ClinicalTrials.gov ↗) Locally Advanced or Metastatic ER+ HER2- Breast Cancer, Locally Advanced or Metastatic Castration-resistant Prostate Cancer, Locally Advanced or Metastatic Non-small Cell Lung Cancer	Phase 2	Recruiting	Pfizer	USA, China
NCT03424005	A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (ClinicalTrials.gov ↗) Metastatic Breast Cancer	Phase 1/2	Recruiting	Hoffmann-La Roche	UK, USA
NCT04802759	A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer (ClinicalTrials.gov ↗) Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer	Phase 1/2	Recruiting	Hoffmann-La Roche	USA
NCT05768139	First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors Breast Cancer, Solid Tumors, Adult	Phase 1/2	Recruiting	Eli Lilly and Company	Ireland, USA
NCT05867251	Study of AVZO-021 in Patients With Advanced Solid Tumors (ClinicalTrials.gov ↗) Advanced Solid Tumor, HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer	Phase 1/2	Recruiting	Avenzo Therapeutics, Inc.	USA
NCT06188520	A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors (ClinicalTrials.gov ↗) ER+ HER2- Advanced Breast Cancer, High-grade Serous Ovarian Cancer (HGSOC)	Phase 1/2	Recruiting	AstraZeneca	UK, USA
NCT06736704	SNV4818 in Participants With Advanced Solid Tumors (ClinicalTrials.gov ↗) Advanced Solid Tumors	Phase 1/2	Recruiting	Pikavation Therapeutics, Inc.	USA
NCT06947811	A Study of Almonertinib Combined With Palbociclib in Patients With Advanced Solid Tumors Harboring KRAS Mutations (ClinicalTrials.gov ↗) EGFR Tyrosine Kinase Inhibitors Plus Cyclin-dependent Kinase 4/6 Inhibitor	Phase 1/2	Recruiting	Sun Yat-sen University	China
NCT07002177	A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC (ClinicalTrials.gov ↗) Metastatic Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II	Phase 1/2	Recruiting	Forward Pharmaceuticals Co., Ltd.	China
NCT05216432	First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Patients With Advanced Solid Tumors and in Combination With Endocrine Therapy +/- a CDK4/6 or CDK4 Inhibitor in Patients With Advanced Solid Tumors or Advanced Breast Cancer (ClinicalTrials.gov ↗) PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer	Phase 1	Recruiting	Relay Therapeutics, Inc.	USA
NCT06997029	A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors (ClinicalTrials.gov ↗) Advanced Solid Tumor, Advanced Breast Cancer, Advanced Ovarian Cancer	Phase 1	Recruiting	Bristol-Myers Squibb	USA
NCT07347600	A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer (ClinicalTrials.gov ↗) Locally Advanced Breast Cancer, Metastatic Breast Cancer	Observational	Recruiting	Hoffmann-La Roche	China
NCT06478927	Backline Treatment of Advanced Hepatocellular Carcinoma With Palbociclib (ClinicalTrials.gov ↗) Hepatocellular Carcinoma	Not applicable	Recruiting	Henan Cancer Hospital	China
NCT07061717	Comparing Endocrine Therapy Combined With High-Dose Palbociclib and Hydroxychloroquine to Endocrine Therapy Combined With Standard-Dose Palbociclib for Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer (ClinicalTrials.gov ↗) Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer	Phase 3	Not yet open	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	China
NCT04605562	Umbrella Biomarker-Guided Therapy in NPC (ClinicalTrials.gov ↗) Nasopharyngeal Carcinoma	Phase 2	Not yet open	Sun Yat-sen University	China
NCT07787520	A Study of LAE118 as Monotherapy and in Combination With Antitumor Agents in Advanced Solid Tumors (ClinicalTrials.gov ↗) Patients With Advanced Solid Tumors	Phase 1	Not yet open	Laekna Limited	China
NCT02513394	PALbociclib CoLlaborative Adjuvant Study (ClinicalTrials.gov ↗) Breast Cancer	Phase 3	Active, closed	Alliance Foundation Trials, LLC.	Ireland
NCT04546009	A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer) (ClinicalTrials.gov ↗) Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer	Phase 3	Active, closed	Hoffmann-La Roche	UK, USA, China
NCT04711252	A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease (ClinicalTrials.gov ↗) ER-Positive HER2-Negative Breast Cancer	Phase 3	Active, closed	AstraZeneca	UK, USA, India, China
NCT04862663	Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) (ClinicalTrials.gov ↗) Locally Advanced (Inoperable) or Metastatic Breast Cancer	Phase 3	Active, closed	AstraZeneca	UK, USA, India, China
NCT04964934	Phase III Study to Assess AZD9833+ CDK4/6 Inhibitor in HR+/HER2-MBC With Detectable ESR1m Before Progression (SERENA-6) (ClinicalTrials.gov ↗) ER-Positive HER2-Negative Breast Cancer	Phase 3	Active, closed	AstraZeneca	UK, USA
NCT05501886	Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1) (ClinicalTrials.gov ↗) Breast Cancer	Phase 3	Active, closed	Celcuity Inc	UK, USA, India, China
NCT06065748	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) (ClinicalTrials.gov ↗) Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer	Phase 3	Active, closed	Hoffmann-La Roche	USA, India, China
NCT06760637	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 (ClinicalTrials.gov ↗) Breast Cancer	Phase 3	Active, closed	Pfizer	Ireland, UK, USA, India, China
NCT04191499	A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer Breast Cancer	Phase 2/3	Active, closed	Hoffmann-La Roche	UK, USA, China
NCT03709680	Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors (ClinicalTrials.gov ↗) Ewing Sarcoma, Solid Tumors, Rhabdoid Tumor	Phase 2	Active, closed	Pfizer	UK, USA, India
NCT04553133	PF-07104091 as a Single Agent and in Combination Therapy Small Cell Lung Cancer, Ovarian Cancer, Breast Cancer	Phase 2	Active, closed	Pfizer	USA, China
NCT04567420	DNA-guided Second Line Adjuvant Therapy for High Residual Risk, Estrogen Receptor Positive, HER-2 Negative Breast Cancer (DARE) (ClinicalTrials.gov ↗) Breast Cancer	Phase 2	Active, closed	Criterium, Inc.	USA
NCT04931342	A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors (ClinicalTrials.gov ↗) Ovarian Cancer	Phase 2	Active, closed	Hoffmann-La Roche	UK, USA
NCT05226871	Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies Breast Cancer, Head and Neck Cancer	Phase 2	Active, closed	Pfizer	USA, China
NCT05468697	A Study of Belzutifan (MK-6482) in Combination With Palbociclib Versus Belzutifan Monotherapy in Participants With Advanced Renal Cell Carcinoma (MK-6482-024/LITESPARK-024) (ClinicalTrials.gov ↗) Renal Cell Carcinoma	Phase 1/2	Active, closed	Merck Sharp & Dohme LLC	USA
NCT05563220	Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer Breast Cancer, Metastatic Breast Cancer	Phase 1/2	Active, closed	Stemline Therapeutics, Inc.	UK, USA
NCT03006172	To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer Breast Cancer, Solid Tumor	Phase 1	Active, closed	Genentech, Inc.	UK, USA
NCT03332797	A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer (ClinicalTrials.gov ↗) Breast Cancer	Phase 1	Active, closed	Genentech, Inc.	UK, USA
NCT04185883	Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101) Advanced Solid Tumors, Kirsten Rat Sarcoma (KRAS) pG12C Mutation	Phase 1	Active, closed	Amgen	UK, USA
NCT05238922	Study of INCB123667 in Subjects With Advanced Solid Tumors (ClinicalTrials.gov ↗) Solid Tumors	Phase 1	Active, closed	Incyte Corporation	UK, USA
NCT06495164	A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer (ClinicalTrials.gov ↗) Breast Cancer, Malignant Neoplasm of Breast	Observational	Active, closed	Pfizer	USA

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

Conditions studied

45 conditions

Condition (as registered)	Trials
Breast Cancer	14
Metastatic Breast Cancer	4
Advanced Solid Tumors	2
ER-Positive HER2-Negative Breast Cancer	2
Advanced Breast Cancer	2
Solid Tumors	2
HR+/HER2- Breast Cancer	2
Ovarian Cancer	2
Advanced Solid Tumor	2
Solid Tumors, Adult	1
Breast Neoplasms	1
Neoplasm Metastasis	1
Kirsten Rat Sarcoma (KRAS) pG12C Mutation	1
Solid Tumor	1
Locally Advanced (Inoperable) or Metastatic Breast Cancer	1
ER+ HER2- Advanced Breast Cancer	1
High-grade Serous Ovarian Cancer (HGSOC)	1
Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer	1
Ewing Sarcoma	1
Rhabdoid Tumor	1
Rhabdomyosarcoma	1
Small Cell Lung Cancer	1
Head and Neck Cancer	1
Locally Advanced or Metastatic ER+ HER2- Breast Cancer	1
Locally Advanced or Metastatic Castration-resistant Prostate Cancer	1
Locally Advanced or Metastatic Non-small Cell Lung Cancer	1
Advanced Ovarian Cancer	1
PIK3CA Mutation	1
Solid Tumor, Adult	1
HER2-negative Breast Cancer	1
Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer	1
Renal Cell Carcinoma	1
Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer	1
Malignant Neoplasm of Breast	1
HR+, HER2-, Advanced Breast Cancer	1
CCNE1 Amplification	1
Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer	1
Locally Advanced Breast Cancer	1
Breast Cancer Stage I	1
Breast Cancer Stage II	1

+ 5 more conditions in the trial records above.

Trials by country register

Register	Palbociclib trials
Clinical trials in USA	33
Clinical trials in China	21
Clinical trials in UK	19
Clinical trials in India	7
Clinical trials in Ireland	4

A trial with sites in more than one country appears in each of those registers.

How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Palbociclib works or whether it is effective. Each trial links to its own record so you can check it yourself.

ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Palbociclib (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 24 Sep 2026.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.

Palbociclib

Clinical trials of Palbociclib

Conditions studied

Sponsors

Trials by country register

How this page is built