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Last Updated: February 12, 2025

CLINICAL TRIALS PROFILE FOR AROMASIN


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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.
NCT00065325 ↗ The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer Completed AstraZeneca Phase 3 2003-08-01 The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.
NCT00066586 ↗ Exemestane in Reducing Breast Density in Postmenopausal Women at Risk for Breast Cancer Completed NCIC Clinical Trials Group N/A 2001-08-01 RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased risk of developing breast cancer. Exemestane may be effective in preventing the development of breast cancer by decreasing estrogen levels and reducing breast density. PURPOSE: Randomized clinical trial to study the effectiveness of exemestane in preventing the development of breast cancer by decreasing estrogen levels and reducing breast density in postmenopausal women who are at increased risk for breast cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Aromasin

Condition Name

Condition Name for Aromasin
Intervention Trials
Breast Cancer 29
Breast Neoplasms 16
HER2/Neu Negative 8
Stage IV Breast Cancer 7
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Condition MeSH

Condition MeSH for Aromasin
Intervention Trials
Breast Neoplasms 76
Carcinoma 6
Breast Neoplasms, Male 4
Neoplasms 4
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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
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Trials by US State

Trials by US State for Aromasin
Location Trials
Florida 20
California 17
Texas 16
Ohio 15
New York 15
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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
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Clinical Trial Status

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

Sponsor Name

Sponsor Name for Aromasin
Sponsor Trials
Pfizer 26
National Cancer Institute (NCI) 21
University of Washington 4
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Sponsor Type

Sponsor Type for Aromasin
Sponsor Trials
Other 90
Industry 57
NIH 21
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AROMASIN (Exemestane): Clinical Trials, Market Analysis, and Projections

Introduction to AROMASIN

AROMASIN, also known as exemestane, is a medication used in the treatment of breast cancer, particularly in postmenopausal women. It is an aromatase inhibitor, which works by reducing the amount of estrogen produced by the body, thereby slowing the growth of estrogen-receptor positive breast cancer cells.

Clinical Trials and Efficacy

Adjuvant Treatment

AROMASIN is indicated for the adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer. Clinical trials, such as the Intergroup Exemestane Study (IES) and the Tamoxifen, Exemestane, Adjuvant, Multicenter (TEAM) Study, have demonstrated the benefits of switching from tamoxifen to AROMASIN after 2-3 years of tamoxifen therapy to complete a total of five consecutive years of adjuvant hormonal therapy. These studies showed that AROMASIN significantly reduced the risk of breast cancer recurrence compared to continued tamoxifen therapy[1][3][4].

Advanced Breast Cancer

For postmenopausal women with advanced breast cancer whose disease has progressed following tamoxifen therapy, AROMASIN has been shown to be effective. Clinical trials have indicated that AROMASIN can improve outcomes in these patients, although it is associated with certain adverse reactions[1][4].

Adverse Reactions

The clinical trials have also highlighted the common adverse reactions associated with AROMASIN. These include musculoskeletal disorders, nervous system disorders, hot flushes, nausea, fatigue, and increased sweating. In the IES study, AROMASIN was associated with a higher incidence of osteoporosis, carpal tunnel syndrome, and neuropathy compared to tamoxifen[1].

Market Analysis

Market Dominance in China

Pharmacia & Upjohn's AROMASIN dominates the Chinese market, accounting for more than 90% of the market share in terms of sales value in 2020. Local Chinese companies such as Qilu Pharmaceutical, Hainan Tongyong Tongmeng Pharmaceutical, and Tongfang Pharmaceutical Group also have a significant presence in the market[2][5].

Sales Volume and Value

Despite the impact of the COVID-19 pandemic, the sales value of exemestane in China continued to grow, reaching approximately CNY400 million (USD61.6 million) in 2020 with a Compound Annual Growth Rate (CAGR) of 9.2% from 2016 to 2020. The sales volume and value are expected to continue growing from 2021 to 2025, driven by the increasing number of breast cancer cases[2][5].

Regional Growth

The Asia Pacific region, particularly China, is expected to drive the growth of the exemestane market. The increasing incidence of breast cancer, due to factors such as changing lifestyles, delayed childbearing, and rising obesity rates, is a significant driver of this growth[2][5].

Market Projections

Forecasted Growth

From 2021 to 2025, the Chinese exemestane market is expected to continue growing due to the rising number of new breast cancer cases. The global market is also projected to grow, driven by advancements in oncology, the shift towards personalized medicine, and the increasing focus on women's health issues globally[2][5].

Market Size Forecast

The exemestane Active Pharmaceutical Ingredient (API) market is expected to reach USD 2.03 billion by 2032, growing at a CAGR of 6.1% from 2024 to 2032. This growth is influenced by ongoing advancements in oncology and the increasing focus on women's health issues[5].

Key Factors Influencing Market Growth

Increasing Breast Cancer Cases

Breast cancer has become the leading cancer worldwide, and the number of new cases is expected to continue growing. This trend is driven by altering risk factors such as delayed childbearing, decreased number of births, overweight, obesity, and lack of exercise[2].

Impact of COVID-19

Despite the challenges posed by the COVID-19 pandemic, the exemestane market in China continued to grow. The pandemic highlighted the resilience of the healthcare sector and the ongoing demand for cancer treatments[2][5].

Market Drivers and Opportunities

The market is driven by the increasing incidence of breast cancer, advancements in healthcare infrastructure, and the shift towards personalized medicine. Emerging markets, particularly in the Asia Pacific region, present significant opportunities for growth[2][5].

Challenges and Threats

High treatment costs and side effects associated with exemestane are challenges that need to be addressed. However, these can also be seen as opportunities for innovation and improvement in treatment options[5].

Conclusion

AROMASIN has established itself as a crucial medication in the treatment of breast cancer, particularly in postmenopausal women. The clinical trials have demonstrated its efficacy in both adjuvant and advanced settings. The market analysis shows a strong presence of AROMASIN in China and a projected growth in the global market driven by increasing breast cancer cases and advancements in oncology.

Key Takeaways

  • Clinical Efficacy: AROMASIN is effective in reducing breast cancer recurrence in postmenopausal women when used as adjuvant therapy and in treating advanced breast cancer.
  • Market Dominance: Pharmacia & Upjohn's AROMASIN dominates the Chinese market.
  • Growing Demand: The demand for exemestane is driven by the rising incidence of breast cancer.
  • Regional Growth: The Asia Pacific region, particularly China, is expected to drive the growth of the exemestane market.
  • Market Size Forecast: The exemestane API market is expected to reach USD 2.03 billion by 2032.

FAQs

What is AROMASIN used for?

AROMASIN (exemestane) is used for the adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer and for the treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy[1][4].

What are the common adverse reactions associated with AROMASIN?

Common adverse reactions include musculoskeletal disorders, nervous system disorders, hot flushes, nausea, fatigue, and increased sweating[1].

Which company dominates the Chinese exemestane market?

Pharmacia & Upjohn's AROMASIN dominates the Chinese market, accounting for more than 90% of the market share in terms of sales value in 2020[2][5].

How has the COVID-19 pandemic affected the exemestane market?

Despite the challenges posed by the COVID-19 pandemic, the sales value of exemestane in China continued to grow, reaching approximately CNY400 million (USD61.6 million) in 2020[2][5].

What are the projected growth prospects for the exemestane market?

The exemestane API market is expected to reach USD 2.03 billion by 2032, growing at a CAGR of 6.1% from 2024 to 2032, driven by the increasing number of breast cancer cases and advancements in oncology[5].

Sources

  1. Pfizer Medical Information: AROMASIN® (exemestane) Patient information - US.
  2. Business Wire: China Exemestane Market Research Report 2021: Sales 2016-2020.
  3. Pfizer: Pfizer Announces Updated Trial Results for AROMASIN® (exemestane tablets) In Switch And Upfront Settings.
  4. Pfizer Medical Information: AROMASIN® (exemestane) Indications and Usage - US.
  5. Drug Patent Watch: Pharmaceutical drug prices and trends for exemestane.

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