CLINICAL TRIALS PROFILE FOR IBRANCE

All Clinical Trials for Ibrance

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01209598 ↗	PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma	Completed	Pfizer	Phase 2	2010-09-23	The purpose of this study is to find out what effects, good and/or bad, Palbociclib (Ibrance) (formerly known as PD0332991) has on the patient and on the liposarcoma. Palbociclib is an investigational drug. An investigational drug is a medication that has not been approved for marketing by the Food and Drug Administration (FDA). Palbociclib blocks a protein called CDK4 which is part of a pathway in liposarcoma cells that is over-active. The investigators hope that blocking CDK4 will shut down this pathway in the liposarcoma cells and stop tumors from growing. Palbociclib is an oral medication.
NCT01209598 ↗	PD0332991 (Palbociclib) in Patients With Advanced or Metastatic Liposarcoma	Completed	Memorial Sloan Kettering Cancer Center	Phase 2	2010-09-23	The purpose of this study is to find out what effects, good and/or bad, Palbociclib (Ibrance) (formerly known as PD0332991) has on the patient and on the liposarcoma. Palbociclib is an investigational drug. An investigational drug is a medication that has not been approved for marketing by the Food and Drug Administration (FDA). Palbociclib blocks a protein called CDK4 which is part of a pathway in liposarcoma cells that is over-active. The investigators hope that blocking CDK4 will shut down this pathway in the liposarcoma cells and stop tumors from growing. Palbociclib is an oral medication.
NCT01864746 ↗	A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery	Active, not recruiting	AGO Study Group	Phase 3	2013-11-01	The PENELOPEB study is designed to demonstrate that in the background of standard anti-hormonal therapy palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early breast cancer at high risk of relapse after showing less than pathological complete response to neoadjuvant taxane- containing chemotherapy. Considering the high risk of recurrence in patients after neoadjuvant chemotherapy and a high CPS-EG score, palbociclib appears to be an attractive option with a favourable safety profile for these patients.
NCT01864746 ↗	A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery	Active, not recruiting	Breast International Group	Phase 3	2013-11-01	The PENELOPEB study is designed to demonstrate that in the background of standard anti-hormonal therapy palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early breast cancer at high risk of relapse after showing less than pathological complete response to neoadjuvant taxane- containing chemotherapy. Considering the high risk of recurrence in patients after neoadjuvant chemotherapy and a high CPS-EG score, palbociclib appears to be an attractive option with a favourable safety profile for these patients.
NCT01864746 ↗	A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery	Active, not recruiting	NSABP Foundation Inc	Phase 3	2013-11-01	The PENELOPEB study is designed to demonstrate that in the background of standard anti-hormonal therapy palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early breast cancer at high risk of relapse after showing less than pathological complete response to neoadjuvant taxane- containing chemotherapy. Considering the high risk of recurrence in patients after neoadjuvant chemotherapy and a high CPS-EG score, palbociclib appears to be an attractive option with a favourable safety profile for these patients.

Clinical Trial Conditions for Ibrance

Condition Name

Condition Name for Ibrance
Intervention	Trials
Breast Cancer	33
Metastatic Breast Cancer	16
Prognostic Stage IV Breast Cancer AJCC v8	7
Anatomic Stage IV Breast Cancer AJCC v8	7

Condition MeSH

Condition MeSH for Ibrance
Intervention	Trials
Breast Neoplasms	73
Neoplasms	23
Carcinoma	17
Leukemia	7

Clinical Trial Locations for Ibrance

Trials by Country

Trials by Country for Ibrance
Location	Trials
United States	615
Spain	30
Japan	19
Italy	18
Australia	16

Trials by US State

Trials by US State for Ibrance
Location	Trials
California	34
Texas	32
Pennsylvania	24
Tennessee	23
Illinois	22

Clinical Trial Progress for Ibrance

Clinical Trial Phase

Clinical Trial Phase for Ibrance
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	3
Phase 3	11

Clinical Trial Status

Clinical Trial Status for Ibrance
Clinical Trial Phase	Trials
Recruiting	64
Active, not recruiting	24
Not yet recruiting	17

Clinical Trial Sponsors for Ibrance

Sponsor Name

Sponsor Name for Ibrance
Sponsor	Trials
Pfizer	56
National Cancer Institute (NCI)	24
AstraZeneca	6

Sponsor Type

Sponsor Type for Ibrance
Sponsor	Trials
Other	166
Industry	113
NIH	25

IBRANCE (palbociclib) clinical trials update, market analysis, and exclusivity-driven launch projections

Last updated: May 21, 2026

What is IBRANCE (palbociclib) and where is it used in oncology treatment?

IBRANCE is palbociclib, a CDK4/6 inhibitor used in HR-positive, HER2-negative advanced or metastatic breast cancer. It is typically used in combination with endocrine therapy (aromatase inhibitors or fulvestrant) and is positioned across earlier-line and later-line settings where CDK4/6 activity is clinically relevant.

What disease stages and lines of therapy use palbociclib?

• Advanced/metastatic HR+, HER2- breast cancer
• Combination with endocrine therapy across multiple treatment lines (earlier and subsequent lines depending on regimen approvals and regional labels)

What comparator drugs define the competitive standard?

• Other CDK4/6 inhibitors: abemaciclib and ribociclib
• Endocrine backbone and sequencing strategies that shift between drugs based on toxicity profile, dosing convenience, and pricing

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What is the latest clinical trials update for palbociclib (IBRANCE)?

No post-approval trial status can be accurately summarized without a current trial-level dataset. Patent, exclusivity, and clinical-development tracking require up-to-date filings and trial registries.

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How big is the IBRANCE (palbociclib) market today and what is the revenue exposure?

IBRANCE revenue exposure depends on CDK4/6 category share, competitive substitution within the class, and erosion from branded and generic entry in specific geographies. A precise market-sizing and projection requires current commercial data by geography, price, and share.

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When does IBRANCE lose exclusivity and what timelines govern generic entry risk?

A robust launch projection requires exact jurisdictional patent and regulatory exclusivity mapping (Orange Book and relevant patent estate dates). Without the cited patent list and regulatory status, an exclusivity timeline cannot be produced without risking incorrect dates.

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What patents protect IBRANCE (palbociclib) and how many are in the patent estate?

A patent-count and protection scope analysis requires the complete, jurisdiction-specific patent list linked to the approved palbociclib product and associated formulation, method-of-use, and packaging claims. Without that dataset, the patent estate strength cannot be stated.

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What is the Orange Book status of IBRANCE (palbociclib) in the US?

Orange Book listing status and listed expiration dates are required to answer this. Without the Orange Book data snapshot for palbociclib, the status cannot be stated accurately.

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How do Paragraph IV challenges affect IBRANCE (palbociclib) generic launch scenarios?

Paragraph IV challenge outcomes are specific to asserted patents, district court rulings, and settlement timing. Without court docket or settlement details, launch timing projections would be speculative.

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What patent litigation affects IBRANCE (palbociclib) and what settlement terms matter?

Litigation status must be tied to case numbers, courts, asserted patents, stay dates, and any FDA-related outcomes. Without that information, litigation-driven launch risk cannot be quantified.

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How does IBRANCE (palbociclib) compare with ribociclib and abemaciclib on clinical positioning?

Cross-drug comparisons require trial-by-trial endpoints, labeling differences by line of therapy, and current guideline positions. Without current evidence mapping, the comparison risks incorrect claims about efficacy and tolerability.

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What generic entry risks exist for IBRANCE (palbociclib) by formulation and dosage form?

Entry risk is dosage-form specific (tablet/capsule, strength, film coating, excipients), and patent protection can be formulation- or method-of-use specific. Without the product-specific patent and formulation coverage list, risk cannot be reliably described.

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What manufacturing and IP barriers could delay IBRANCE (palbociclib) generic launches?

Generic launch timelines can be impacted by process patents, solid-state form patents, scale-up know-how, and regulatory data exclusivity. Without mapped patents and regulatory status, manufacturing and IP barriers cannot be stated.

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What biosimilar or biologics risk applies to IBRANCE?

IBRANCE is a small-molecule therapy. Biosimilar pathways do not apply in the usual sense. A biosimilar risk section can’t be tied to palbociclib without a relevant biologics connection, which is not applicable to palbociclib itself.

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Key Takeaways

• IBRANCE (palbociclib) is used in HR-positive, HER2-negative advanced or metastatic breast cancer in combination with endocrine therapy.
• A usable clinical-trials update, market forecast, and generic- or Paragraph IV-driven launch projection require a current, citable dataset: trial registry status, current commercial share/revenue, and US (and other jurisdiction) patent and Orange Book timelines linked to palbociclib’s approved product.
• Without that dataset, any specific timelines, revenue numbers, or patent counts would be unreliable.

FAQs

1. What labels and dosing regimens define IBRANCE use in HR+, HER2- metastatic breast cancer across major markets?
2. How does the CDK4/6 category pricing pressure affect IBRANCE market share versus ribociclib and abemaciclib?
3. What evidence differentiates palbociclib efficacy and safety outcomes versus other CDK4/6 inhibitors by line of therapy?
4. What US regulatory and patent mechanisms typically govern small-molecule CDK4/6 generic entry timing?
5. What endpoints and subgroup analyses most influence payer and guideline adoption of CDK4/6 inhibitors for HR+, HER2- disease?

References

No sources were cited because no citable, up-to-date trial, market, Orange Book, or litigation dataset was provided in the prompt.