CLINICAL TRIALS PROFILE FOR AROMASIN

All Clinical Trials for AROMASIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00036270 ↗	Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane	Completed	Pfizer	Phase 3	2001-08-01	To compare the effects of exemestane for 5 years versus tamoxifen and exemestane given sequentially over 5 years in the adjuvant treatment of postmenopausal women with early breast cancer. This Pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studies in 9 countries. This study is designed to be part of the larger TEAM trial where the data from these 7 studies will be combined. A pre-specified analysis of the pooled data will be conducted.
NCT00038103 ↗	Open-Label Study Of Exemestane With Or Without Celecoxib In Postmenopausal Women With ABC Having Progressed On Tamoxifen	Completed	Pfizer	Phase 2	2002-01-01	This is an open-label, multicenter, randomized (1:1 randomization ratio) study of either exemestane or exemestane plus celecoxib in postmenopausal women with ABC having progressed on tamoxifen.
NCT00040014 ↗	Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women	Terminated	Pfizer	Phase 2	2002-06-01	The purpose of this study is to find out if the two different formulations of exemestane (Aromasin), oral and injectable, are equivalent in terms of pharmacodynamics and pharmacokinetics, i.e., if ultimately both formulations have the same efficacy in postmenopausal women with metastatic breast cancer who have failed previous antiestrogens therapy and are equally safe.

Clinical Trial Conditions for AROMASIN

Condition Name

Condition Name for AROMASIN
Intervention	Trials
Breast Cancer	29
Breast Neoplasms	16
HER2/Neu Negative	8

Condition MeSH

Condition MeSH for AROMASIN
Intervention	Trials
Breast Neoplasms	76
Carcinoma	6
Breast Neoplasms, Male	4

Clinical Trial Locations for AROMASIN

Trials by Country

Trials by Country for AROMASIN
Location	Trials
United States	501
Canada	45
Japan	42
China	38
Romania	18

Trials by US State

Trials by US State for AROMASIN
Location	Trials
Florida	20
California	17
Texas	16
Ohio	15
New York	15

Clinical Trial Progress for AROMASIN

Clinical Trial Phase

Clinical Trial Phase for AROMASIN
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	19
Phase 2	39

Clinical Trial Status

Clinical Trial Status for AROMASIN
Clinical Trial Phase	Trials
Completed	38
Active, not recruiting	16
Terminated	13

Clinical Trial Sponsors for AROMASIN

Sponsor Name

Sponsor Name for AROMASIN
Sponsor	Trials
Pfizer	26
National Cancer Institute (NCI)	21
International Breast Cancer Study Group	4

Sponsor Type

Sponsor Type for AROMASIN
Sponsor	Trials
Other	90
Industry	57
NIH	21

Clinical Trials Update, Market Analysis, and Projection for Aromasin (Exemestane)

Last updated: October 30, 2025

Introduction

Aromasin (exemestane) is an oral aromatase inhibitor predominantly prescribed to treat estrogen receptor-positive (ER+) breast cancer in postmenopausal women. Since its approval by the FDA in 1999, Aromasin has cemented its role within the endocrine therapy landscape. This report offers an in-depth update on ongoing and completed clinical trials, a comprehensive market analysis, and future market projections for Aromasin.

Clinical Trials Update

Current and Recent Clinical Trials

Recent years have seen an increased emphasis on evaluating exemestane beyond its traditional use in early-stage breast cancer. Key clinical trials include:

• AMAZONA Trials: The ongoing AMAZONA phase III trial assesses exemestane's efficacy in metastatic ER+ breast cancer patients resistant to other endocrine therapies. Results are expected to elucidate its role in treatment-resistant populations.

• Combination Therapy Investigations: Multiple studies are exploring exemestane in combination with targeted agents such as CDK4/6 inhibitors (e.g., palbociclib, abemaciclib). For example, a recent phase II trial (NCT03838756) evaluated exemestane plus palbociclib in advanced breast cancer, aiming to enhance progression-free survival (PFS).

• Prevention Trials: The IBIS-II trial, a prominent prevention trial, continues to explore exemestane's efficacy in reducing breast cancer incidence among high-risk postmenopausal women. The latest update reports a statistically significant reduction in invasive breast cancers, bolstering its preventive indication.

Innovations and Future Directions

• Biomarker-driven Trials: Researchers are investigating genomic markers predictive of response to exemestane, such as aromatase gene polymorphisms, to refine patient selection.

• Extended Indications: Emerging data suggest potential in male breast cancer and certain gynecological cancers, prompting ongoing exploratory trials.

• Real-World Evidence: Post-marketing studies indicate consistent efficacy and tolerability, with ongoing registry analyses providing additional safety data.

Summary of FDA-Approved and Key Trials

While exemestane remains FDA-approved for postmenopausal hormone receptor-positive breast cancer, recent trials are expanding its scope into adjuvant and metastatic settings, particularly in combination therapies aimed at overcoming resistance mechanisms.

Market Analysis

Market Landscape and Drivers

The global aromatase inhibitors market, valued at approximately USD 5.8 billion in 2022, is projected to grow at a Compound Annual Growth Rate (CAGR) of 6.2% through 2030 [1]. Aromasin holds a significant share in this market owing to its established efficacy and safety profile.

Factors driving market growth include:

• Rising Incidence of Breast Cancer: Breast cancer remains the most diagnosed cancer globally, with approximately 2.3 million new cases globally in 2020 [2].

• Shift Toward Targeted Endocrine Therapies: Increasing adoption of androgen receptor-targeted therapies and combination regimens enhances exemestane’s demand.

• Expanded Indications: Ongoing trials for chemopreventive and metastatic use cases could broaden Aromasin’s applications.

• Patent Expiry and Generics: The expiration of patents for branded exemestane (Aromasin) in several markets has facilitated entry of generic versions, expanding access and influencing market dynamics.

Competitive Landscape

Aromasin’s primary competitors include:

• Letrozole (Femara): Widely used, with a larger market share owing to earlier approval and extensive clinical data.

• Anastrozole (Arimidex): Established first-line endocrine therapy in ER+ breast cancer.

• Emerging Selective Estrogen Receptor Degraders (SERDs): Such as fulvestrant and oral SERDs in clinical trials, potentially challenging aromatase inhibitors in certain treatment settings.

Market Challenges

• Side Effect Profile: Aromatase inhibitors, including exemestane, are associated with osteoporosis, arthralgia, and cardiovascular risks, impacting adherence.

• Resistance Development: Resistance to aromatase inhibitors remains a challenge, necessitating combination therapies.

• Pricing and Reimbursement: Variations in healthcare policies impact market penetration, especially with the proliferation of generics.

Market Projection

Forecast Overview

• The Aromasin segment is expected to sustain its market dominance in ER+ breast cancer treatment, driven by ongoing clinical validation and expanding indications.

• The global market for aromatase inhibitors is forecasted to reach USD 9.1 billion by 2030 [1].

• Aromasin’s share is projected to grow modestly, especially owing to:

  • Increasing use in advanced and adjuvant settings.

  • Integration in combination regimens with CDK4/6 inhibitors, potentially elevating its market value due to improved outcomes.

  • Adoption in preventive therapy among high-risk populations.

Market Segmentation and Regional Outlook

• North America: Leading market with high adoption rates, supported by strong healthcare infrastructure and robust clinical trial activity.

• Europe: Significant growth potential; regional approval and reimbursement policies favor aromatase inhibitor use.

• Asia-Pacific: Rapid growth driven by increasing breast cancer incidence, expanding healthcare access, and emerging markets.

Strategic Opportunities

• Combination Therapies: Synthesizing exemestane with targeted agents offers lucrative opportunities owing to improved efficacy.

• Biomarker Development: Tailoring therapy based on predictive markers could enhance market share and patient outcomes.

• New Indications: Expanding into male breast cancer and other hormone-dependent gynecological cancers opens additional revenue streams.

Key Takeaways

• Clinical Dynamics: Exemestane remains under active clinical investigation, with promising data supporting its expanded use in metastatic, adjuvant, and preventive contexts. Evolving combination strategies with targeted agents are particularly noteworthy.

• Market Position: Aromasin’s established efficacy and expanding evidence base underpin its sustained market relevance, despite competitive pressures from other aromatase inhibitors and emerging SERDs.

• Market Opportunities: Strategic focus on combination regimens and biomarker-guided therapy will be vital for growth. Geographic expansion, especially in emerging markets, offers additional upside.

• Challenges: Addressing adverse effects, resistance, and reimbursement hurdles remains critical to maximize Aromasin’s market potential.

• Future Outlook: The aromatase inhibitors market is poised for steady growth through 2030, with Aromasin positioned as a significant player, supported by clinical validation and pipeline advancements.

References

[1] Grand View Research. “Aromatase Inhibitors Market Size, Share & Trends Analysis Report,” 2022.

[2] World Health Organization. “Breast Cancer Fact Sheet,” 2021.

FAQs

Q1: What are the primary clinical indications for Aromasin?
Aromasin is primarily indicated for adjuvant treatment of estrogen receptor-positive early breast cancer in postmenopausal women, as well as for metastatic ER+ breast cancer.

Q2: How does Aromasin compare to other aromatase inhibitors like letrozole and anastrozole?
Aromasin has a unique mechanism as a steroidal aromatase inhibitor, leading to irreversible binding, whereas non-steroidal inhibitors like letrozole and anastrozole are reversible. Clinical efficacy varies minimally; choice depends on tolerability, patient profile, and physician preference.

Q3: Are there ongoing trials exploring Aromasin’s preventive use?
Yes, trials such as IBIS-II continue evaluating exemestane for breast cancer prevention in high-risk populations, with positive interim results supporting its preventive efficacy.

Q4: What are the main side effects associated with Aromasin?
Common adverse effects include osteoporosis, joint pain, hot flashes, and cardiovascular risks. Long-term use warrants monitoring bone mineral density and cardiovascular health.

Q5: What is the outlook for Aromasin’s market share over the next decade?
Given the expanding therapeutic landscape, Aromasin’s market share is expected to remain substantial, particularly with successful trials of combination therapies and broader indications, though competition from newer agents and generics will influence its market dynamics.

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Note: This analytical overview synthesizes publicly available information and recent clinical developments to aid strategic decision-making within the pharmaceutical and biotech sectors.