CLINICAL TRIALS PROFILE FOR PALBOCICLIB

505(b)(2) Clinical Trials for PALBOCICLIB

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT01522989 ↗	PD-0332991, 5-FU, and Oxaliplatin for Advanced Solid Tumor Malignancies	Unknown status	Pfizer	Phase 1	2011-12-01	This study is for patients with advanced solid tumor malignancies (cancer that has spread to other parts of the body). The purpose of this study is to test the safety and effectiveness of a new combination of drugs, PD-0332991 and 5-Fluorouracil and Oxaliplatin for patients with advanced solid tumor malignancies . PD-0332991 stops cells from dividing by blocking an enzyme called cyclin-dependent kinase (CDK), which cancer cells need to grow and divide. By inhibiting this enzyme, PD-0332991 prevent cancer cells from growing and dividing, while the 5-Fluorouracil and Oxaliplatin damage the cells, hopefully increasing the killing of cancer cells, thus decreasing the tumors in the body. PD-0332991 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration for use in colorectal cancer. It is given as a pill which is taken once a day for one week followed by one week off. 5-Fluorouracil and Oxaliplatin are administered as an infusion into a vein once every 2 weeks and are approved for and used as chemotherapy for several cancers.
New Combination	NCT01522989 ↗	PD-0332991, 5-FU, and Oxaliplatin for Advanced Solid Tumor Malignancies	Unknown status	Georgetown University	Phase 1	2011-12-01	This study is for patients with advanced solid tumor malignancies (cancer that has spread to other parts of the body). The purpose of this study is to test the safety and effectiveness of a new combination of drugs, PD-0332991 and 5-Fluorouracil and Oxaliplatin for patients with advanced solid tumor malignancies . PD-0332991 stops cells from dividing by blocking an enzyme called cyclin-dependent kinase (CDK), which cancer cells need to grow and divide. By inhibiting this enzyme, PD-0332991 prevent cancer cells from growing and dividing, while the 5-Fluorouracil and Oxaliplatin damage the cells, hopefully increasing the killing of cancer cells, thus decreasing the tumors in the body. PD-0332991 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration for use in colorectal cancer. It is given as a pill which is taken once a day for one week followed by one week off. 5-Fluorouracil and Oxaliplatin are administered as an infusion into a vein once every 2 weeks and are approved for and used as chemotherapy for several cancers.
New Combination	NCT04012918 ↗	Capecitabine in Combination With Aromatase Inhibitor Versus Aromatase Inhibitors, in Hormonal Receptor Positive Recurrent or Metastatic Breast Cancer Patients, Randomized Controlled Study	Unknown status	Ain Shams University	Phase 2	2018-08-30	Women with recurrent or metastatic breast cancer who are hormone receptor positive are candidates for first line hormonal therapy including aromatase inhibitors. In the past few years new combination therapies became available as fulvastrant or palbociclib with letrezole; increasing the progression free survival (PFS). A retrospective study showed that combination of capecitabine with aromatase inhibitors increase PFS as 1st and 2nd line line treatment another prospective study showed the same results. The aim of our study is confirm such data by a randomized controlled trial.
New Combination	NCT05721443 ↗	Cetuximab Plus Dalpicilib in Patients With HPV Negative, PD-1 Resistant R/M HNSCC	Recruiting	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University	Phase 2	2023-04-01	This study is the first clinical study in PD-1 resistant patients with head and neck squamous cell carcinoma with drugs targeting EGFR signaling pathway combined with CDK4/6 inhibitors, which explores the new combination therapies urgently needed in clinical practice and lays a foundation for subsequent studies, with important scientific research significance and clinical value.

All Clinical Trials for PALBOCICLIB

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00141297 ↗	A Study Of Oral Palbociclib (PD-0332991), A Cyclin-Dependent Kinase Inhibitor, In Patients With Advanced Cancer	Completed	Pfizer	Phase 1	2004-09-01	PD-0332991 may work in cancer by stopping cancer cells from multiplying. PD-0332991 is in a new class of drugs called cyclin-dependent kinase (CDK inhibitors). This research study is the first time that PD-0332991 will be given to people. PD-0332991 is taken by mouth daily.
NCT00420056 ↗	An Investigational Study Drug, Palbociclib (PD-0332991), Is Being Studied In Patients With Mantle Cell Lymphoma. Patients Must Have Received Prior Treatment(s) For Mantle Cell Lymphoma.	Completed	Pfizer	Phase 1	2007-05-01	This is a pilot study evaluating tumor activity using Positron Emission Tomography, which is also known as a "PET scan". This study will assess the safety of using PD-0332991 in patients with mantle cell lymphoma.
NCT00555906 ↗	An Investigational Drug, Palbociclib (PD-0332991), Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma.	Completed	Pfizer	Phase 2	2008-01-01	This is a Phase 1/2 study evaluating the safety and anti-tumor activity of PD 0332991 in combination with Velcade® [bortezomib] and dexamethasone in patients who have received at least one previous treatment for multiple myeloma.
NCT00721409 ↗	Study Of Letrozole With Or Without Palbociclib (PD-0332991) For The First-Line Treatment Of Hormone-Receptor Positive Advanced Breast Cancer	Completed	Pfizer	Phase 2	2008-09-15	The study is aimed to confirm that letrozole + PD 0332991 is safe and tolerable and to assess the effect of the combination on advanced breast cancer

Clinical Trial Conditions for PALBOCICLIB

Condition Name

Condition Name for PALBOCICLIB
Intervention	Trials
Breast Cancer	74
Metastatic Breast Cancer	42
Advanced Breast Cancer	16
Breast Neoplasms	14

Condition MeSH

Condition MeSH for PALBOCICLIB
Intervention	Trials
Breast Neoplasms	183
Neoplasms	36
Carcinoma	27
Lymphoma	12

Clinical Trial Locations for PALBOCICLIB

Trials by Country

Trials by Country for PALBOCICLIB
Location	Trials
Spain	115
Italy	97
Canada	89
Japan	85
China	80

Trials by US State

Trials by US State for PALBOCICLIB
Location	Trials
California	73
Texas	63
New York	58
Massachusetts	54
Tennessee	52

Clinical Trial Progress for PALBOCICLIB

Clinical Trial Phase

Clinical Trial Phase for PALBOCICLIB
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	6
PHASE2	5

Clinical Trial Status

Clinical Trial Status for PALBOCICLIB
Clinical Trial Phase	Trials
Recruiting	140
Completed	49
Active, not recruiting	48

Clinical Trial Sponsors for PALBOCICLIB

Sponsor Name

Sponsor Name for PALBOCICLIB
Sponsor	Trials
Pfizer	127
National Cancer Institute (NCI)	30
AstraZeneca	18

Sponsor Type

Sponsor Type for PALBOCICLIB
Sponsor	Trials
Other	338
Industry	264
NIH	31

Clinical Trials Update, Market Analysis, and Projection for Palbociclib

Last updated: October 30, 2025

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Introduction

Palbociclib, marketed as Ibrance, is a groundbreaking CDK4/6 inhibitor indicated primarily for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–) advanced or metastatic breast cancer. Since its FDA approval in 2015, Palbociclib has significantly reshaped treatment paradigms, offering improved progression-free survival and quality of life for metastatic breast cancer patients. This analysis explores recent clinical trial developments, evaluates current market dynamics, and projects future growth trajectories for Palbociclib over the upcoming decade.

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Clinical Trials Update

Ongoing and Recent Clinical Developments

Since its initial approval, Palbociclib's clinical research has expanded into various oncological indications, with multiple pivotal trials enhancing its therapeutic scope.

• Monotherapy and Combination Regimens: Current trials, such as PALOMA-3 and PALOMA-4, continue to evaluate Palbociclib's efficacy in combination with hormonal therapies in both early- and late-stage breast cancer. Notably, PALOMA-3 demonstrated a median progression-free survival (mPFS) of 9.5 months versus 3.8 months with placebo (hazard ratio [HR]=0.46), solidifying its role in endocrine-resistant disease [1].

• Expansion into Other Cancers: Several phase I and II trials are exploring Palbociclib's utility in other solid tumors. For example, PALLAS is assessing its efficacy in early breast cancer, while trials investigating CDK4/6 inhibition in non-small cell lung carcinoma (NSCLC) and ovarian cancer are underway, although these remain early phases.

• Biomarker-Driven Stratification: A significant trend involves identifying predictive biomarkers for responsiveness. Trials integrating genomic profiling aim to refine patient selection, maximizing benefits and minimizing adverse effects.

Safety and Tolerability Data

Clinical data affirm Palbociclib's manageable safety profile, characterized primarily by hematologic adverse events such as neutropenia, leukopenia, and anemia. Recent trials incorporate dose modifications and supportive care strategies to mitigate these effects, enhancing tolerability in extended use [2].

Regulatory Updates

In late 2022, regulatory agencies approved Palbociclib for additional indications including early HR+/HER2– breast cancer as an adjuvant therapy, based on promising phase III trial results (e.g., PENELOPE-B). This broadens its clinical application and portends increased utilization.

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Market Analysis

Current Market Landscape

Since its launch, Palbociclib has established a dominant position in the CDK4/6 inhibitor segment. Key players include Pfizer (manufacturer), with competitors like Novartis’s Ribociclib and Eli Lilly’s Abemaciclib gaining market share.

• Sales Performance: Global sales of Palbociclib surpassed USD 2.8 billion in 2022, reflecting robust demand driven by high clinical efficacy and expanded label indications [3].

• Market Penetration: The drug's penetration remains strongest in North America, particularly the U.S., with promising expansion into European and Asian markets as regulatory approvals accrue.

Competitive Landscape

The landscape is characterized by intense competition among CDK4/6 inhibitors:

Drug	Market Share (2022)	Unique Features
Palbociclib (Ibrance)	~55%	First approved; established in HR+/HER2– breast cancer
Ribociclib (Kisqali)	~30%	Once-daily dosing; favorable myocarditis profile
Abemaciclib (Verzenio)	~15%	Continuous dosing; single-agent activity in certain settings

Despite these competitors, Palbociclib retains a leading position due to its early market entry and extensive clinical validation.

Future Market Projections

Analysts project the Palbociclib market to maintain a compounded annual growth rate (CAGR) of approximately 8–10% from 2023 to 2030. Key growth drivers include:

• Expanded Indications: Incorporation into early-stage breast cancer and other tumor types will broaden the patient base.

• Geographical Expansion: Growth in emerging markets, driven by increasing healthcare infrastructure and cancer awareness.

• Combination Therapy Adoption: Use alongside targeted agents and immunotherapies could enhance efficacy, attracting new clinical applications.

• Breast Cancer Incidence Trends: Rising global incidence, especially in aging populations, supports sustained demand.

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Market Challenges and Risks

• Pricing and Cost-Effectiveness: High drug costs pose barriers, especially in cost-sensitive regions. Payor resistance and value-based pricing models could impact sales.

• Competition: Rivals’ pipeline advancements threaten to erode market share if superior or more convenient options emerge.

• Regulatory and Reimbursement: Variability in regulatory approval timelines and reimbursement policies across jurisdictions could delay market penetration.

• Resistance Development: Long-term efficacy may be compromised by emerging resistance mechanisms, necessitating combination strategies or new agents.

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Strategic Outlook and Recommendations

• R&D Focus: Investing in biomarkers and predictive diagnostics will refine patient selection, optimizing outcomes and reducing toxicity.

• Market Expansion: Proactive entry into Asian, Latin American, and Middle Eastern markets through strategic partnerships and localized clinical trials will capitalize on unmet needs.

• Portfolio Diversification: Developing formulations (e.g., fixed-dose combinations) and exploring new indications could sustain revenue growth.

• Partnerships: Collaborations with biotech firms exploring novel CDK inhibitors or resistance modulators can enhance competitive positioning.

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Conclusion

Palbociclib stands at the forefront of targeted breast cancer therapy, with ongoing clinical trials promising expanded indications and improved patient outcomes. The drug’s market outlook remains optimistic, supported by its proven efficacy, expanding indications, and a robust pipeline. Maintaining competitive advantage will require strategic focus on biomarker integration, geographic expansion, and addressing cost concerns.

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Key Takeaways

• Clinical Trials: Ongoing studies validate Palbociclib’s efficacy in early-stage breast cancer and explore its potential in other tumor types, with safety profiles confirming manageable toxicity.

• Market Dominance: Palbociclib commands a significant share in the CDK4/6 inhibitor market; sales are projected to sustain growth driven by expanded indications and geographic penetration.

• Competitive Edge: Early market entry, extensive clinical validation, and a broadening label position Palbociclib favorably relative to rivals.

• Growth Drivers: Demographic trends, clinical advancements, and the strategic expansion into new markets and indications underpin optimistic projections.

• Challenges: Cost hurdles, emerging resistance, and intense competition necessitate ongoing innovation and strategic agility.

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FAQs

1. What are the upcoming indications for Palbociclib?
Recent trials suggest potential approval for early-stage breast cancer as an adjuvant therapy and exploration in other cancers such as NSCLC and ovarian tumors, broadening its therapeutic scope.

2. How does Palbociclib compare to other CDK4/6 inhibitors?
While all three are effective, Palbociclib was the first approved and remains dominant; differences include dosing schedules and side effect profiles, with ongoing head-to-head studies clarifying comparative efficacy.

3. What are the primary safety concerns associated with Palbociclib?
Neutropenia is the most common adverse event, often manageable with dose modifications. Less frequent concerns include fatigue, infections, and gastrointestinal disturbances.

4. How are regulatory bodies influencing Palbociclib’s expansion?
Regulatory approvals, particularly in Europe and Asia, underpin market expansion. Recent approvals for early-stage breast cancer after positive trial outcomes are promising for growth.

5. What strategic steps should industry stakeholders focus on?
Prioritize biomarker-driven patient selection, geographic expansion, value-based pricing negotiations, and R&D investments into combination therapies to sustain market leadership.

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References

[1] Turner, N.C., et al. (2015). Palbociclib in Hormone-Receptor–Positive Advanced Breast Cancer. New England Journal of Medicine.
[2] Xu, B., et al. (2021). Safety Profile of Palbociclib: A Meta-Analysis. Clinical Oncology.
[3] IQVIA. (2022). Global Oncology Drug Sales Report.

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Note: Data and projections are based on publicly available sources and current industry analyses as of 2023.