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Last Updated: February 8, 2025

CLINICAL TRIALS PROFILE FOR FEMARA


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505(b)(2) Clinical Trials for Femara

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 NCT02520063 ↗ Preoperative Combination of Letrozole, Everolimus, and TRC105 in Postmenopausal Hormone-Receptor Positive and Her2 Negative Breast Cancer Active, not recruiting Novartis Pharmaceuticals Phase 1/Phase 2 2016-02-01 This study will test how well a new combination of three drugs (Letrozole, Everolimus, and TRC105) is tolerated and how well it works in Stage 2 and 3 breast cancer when given prior to definitive surgery. Letrozole blocks the estrogen receptor expressed by many breast cancers while everolimus blocks signals that drive cancer cells to grow. TRC105 is an investigational drug that blocks the formation and growth of blood vessels that feed the cancer and promote its growth. The goal of this study is to investigate the safety and efficacy of this multitargeted approach in breast cancer.
New Combination NCT02520063 ↗ Preoperative Combination of Letrozole, Everolimus, and TRC105 in Postmenopausal Hormone-Receptor Positive and Her2 Negative Breast Cancer Active, not recruiting Tracon Pharmaceuticals Inc. Phase 1/Phase 2 2016-02-01 This study will test how well a new combination of three drugs (Letrozole, Everolimus, and TRC105) is tolerated and how well it works in Stage 2 and 3 breast cancer when given prior to definitive surgery. Letrozole blocks the estrogen receptor expressed by many breast cancers while everolimus blocks signals that drive cancer cells to grow. TRC105 is an investigational drug that blocks the formation and growth of blood vessels that feed the cancer and promote its growth. The goal of this study is to investigate the safety and efficacy of this multitargeted approach in breast cancer.
New Combination NCT02520063 ↗ Preoperative Combination of Letrozole, Everolimus, and TRC105 in Postmenopausal Hormone-Receptor Positive and Her2 Negative Breast Cancer Active, not recruiting University of Alabama at Birmingham Phase 1/Phase 2 2016-02-01 This study will test how well a new combination of three drugs (Letrozole, Everolimus, and TRC105) is tolerated and how well it works in Stage 2 and 3 breast cancer when given prior to definitive surgery. Letrozole blocks the estrogen receptor expressed by many breast cancers while everolimus blocks signals that drive cancer cells to grow. TRC105 is an investigational drug that blocks the formation and growth of blood vessels that feed the cancer and promote its growth. The goal of this study is to investigate the safety and efficacy of this multitargeted approach in breast cancer.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Femara

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00003140 ↗ Letrozole After Tamoxifen in Treating Women With Breast Cancer Completed Cancer and Leukemia Group B Phase 3 1998-08-24 RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. PURPOSE: This randomized phase III trial is studying letrozole to see how well it works in treating women with breast cancer who have received tamoxifen for at least 5 years.
NCT00003140 ↗ Letrozole After Tamoxifen in Treating Women With Breast Cancer Completed Eastern Cooperative Oncology Group Phase 3 1998-08-24 RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. PURPOSE: This randomized phase III trial is studying letrozole to see how well it works in treating women with breast cancer who have received tamoxifen for at least 5 years.
NCT00003140 ↗ Letrozole After Tamoxifen in Treating Women With Breast Cancer Completed European Organisation for Research and Treatment of Cancer - EORTC Phase 3 1998-08-24 RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. PURPOSE: This randomized phase III trial is studying letrozole to see how well it works in treating women with breast cancer who have received tamoxifen for at least 5 years.
NCT00003140 ↗ Letrozole After Tamoxifen in Treating Women With Breast Cancer Completed International Breast Cancer Study Group Phase 3 1998-08-24 RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by reducing the production of estrogen. PURPOSE: This randomized phase III trial is studying letrozole to see how well it works in treating women with breast cancer who have received tamoxifen for at least 5 years.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Femara

Condition Name

Condition Name for Femara
Intervention Trials
Breast Cancer 62
Metastatic Breast Cancer 11
Breast Neoplasms 10
Estrogen Receptor Positive 10
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Condition MeSH

Condition MeSH for Femara
Intervention Trials
Breast Neoplasms 117
Carcinoma 20
Polycystic Ovary Syndrome 13
Infertility 12
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Clinical Trial Locations for Femara

Trials by Country

Trials by Country for Femara
Location Trials
United States 678
Canada 43
Spain 22
Egypt 17
Ireland 14
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Trials by US State

Trials by US State for Femara
Location Trials
Texas 37
California 31
Florida 27
Massachusetts 25
Washington 23
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Clinical Trial Progress for Femara

Clinical Trial Phase

Clinical Trial Phase for Femara
Clinical Trial Phase Trials
Phase 4 23
Phase 3 29
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for Femara
Clinical Trial Phase Trials
Completed 78
Recruiting 37
Active, not recruiting 26
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Clinical Trial Sponsors for Femara

Sponsor Name

Sponsor Name for Femara
Sponsor Trials
National Cancer Institute (NCI) 39
Novartis Pharmaceuticals 16
Novartis 15
[disabled in preview] 13
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Sponsor Type

Sponsor Type for Femara
Sponsor Trials
Other 264
Industry 92
NIH 45
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Clinical Trials, Market Analysis, and Projections for FEMARA (Letrozole)

Introduction to FEMARA (Letrozole)

FEMARA, also known as letrozole, is a non-steroidal aromatase inhibitor used primarily in the treatment of hormone receptor-positive breast cancer. It works by inhibiting the aromatase enzyme, which is involved in the synthesis of estrogen, thereby reducing estrogen levels in the body.

Clinical Trials Overview

Ongoing and Recent Trials

Several clinical trials are ongoing or have recently concluded to assess the efficacy and safety of letrozole in various breast cancer settings.

UCSD Clinical Trial: Prolonged Adjuvant Hormonal Therapy

A phase 3, double-blind, multicenter, placebo-controlled study at UCSD is evaluating whether prolonged adjuvant hormonal therapy with letrozole versus placebo improves disease-free survival in postmenopausal women with estrogen receptor-positive and/or progesterone receptor-positive breast cancer. This study, which is expected to end in April 2025, also compares overall survival, breast cancer-free interval, distant recurrence, and the incidence of osteoporotic-related fractures and arterial thrombotic events among the treatment groups[4].

UCSF Clinical Trial: Alpelisib Plus Fulvestrant or Letrozole

Although not exclusively focused on letrozole, a phase II study at UCSF is assessing the efficacy and safety of alpelisib plus fulvestrant or letrozole in patients with PIK3CA mutant, HR+, HER2- advanced breast cancer. This study highlights the ongoing interest in combining letrozole with other therapies to enhance treatment outcomes[1].

Key Objectives and Outcomes

  • Disease-Free Survival: Studies like the UCSD trial aim to determine whether extended use of letrozole can improve disease-free survival in postmenopausal women who have already completed 5 years of hormonal therapy[4].
  • Overall Survival: Comparisons of overall survival between letrozole and placebo groups are crucial in understanding the long-term benefits of prolonged adjuvant therapy.
  • Safety Profile: Trials also focus on the safety profile, including the incidence of osteoporotic-related fractures and arterial thrombotic events, which are significant concerns with long-term aromatase inhibitor use[4].

Market Analysis

Current Market Size and Growth

The market for breast cancer treatments, including aromatase inhibitors like letrozole, is substantial and growing. Here are some key market insights:

  • Global Market: The global breast cancer treatment market is part of a larger oncology market. While specific figures for letrozole are not isolated, the overall breast cancer treatment market is expected to grow significantly due to increasing incidence rates and advancements in treatment options.
  • Competitive Landscape: The market for breast cancer treatments is highly competitive, with several major pharmaceutical companies such as Novartis, Pfizer, and Bayer AG playing significant roles. Letrozole, being a well-established drug, faces competition from other aromatase inhibitors and emerging therapies[2].

Market Drivers and Restraints

  • Market Drivers: The increasing prevalence of breast cancer, especially in postmenopausal women, drives the demand for effective treatments like letrozole. Advances in diagnostic techniques and growing awareness about breast cancer also contribute to market growth.
  • Market Restraints: Side effects associated with long-term use of aromatase inhibitors, such as osteoporosis and cardiovascular events, can restrain market growth. Additionally, the presence of generic versions of letrozole can impact the market share of branded products[2][3].

Distribution Channels and Regional Markets

  • Distribution Channels: Letrozole is distributed through various channels including hospital pharmacies, online pharmacies, and retail pharmacies. The ease of access through these channels contributes to its market presence[2].
  • Regional Markets: The demand for letrozole is global, with significant markets in the Americas, Europe, and the Asia-Pacific region. Regional differences in healthcare infrastructure, regulatory environments, and patient demographics influence market dynamics[2].

Projections and Future Outlook

Market Growth Projections

The breast cancer treatment market, which includes letrozole, is expected to continue growing due to several factors:

  • Increasing Incidence: The rising incidence of breast cancer, particularly in aging populations, will drive the demand for effective treatments.
  • Advancements in Treatment: Ongoing research and development in breast cancer therapies, including combination therapies involving letrozole, will contribute to market growth.
  • Personalized Medicine: The trend towards personalized treatment approaches, including genetic testing to identify suitable candidates for letrozole, is expected to enhance treatment outcomes and market growth[2].

Technological and Regulatory Trends

  • Digital Health Technologies: The integration of digital health technologies for symptom tracking and management will improve patient outcomes and compliance, potentially increasing the market for letrozole.
  • Regulatory Environment: Changes in regulatory policies and the approval of new indications can significantly impact the market for letrozole. For instance, approvals for extended adjuvant therapy can expand the patient population eligible for treatment[2].

Key Takeaways

  • Clinical Trials: Ongoing trials are evaluating the efficacy and safety of letrozole in various breast cancer settings, including prolonged adjuvant therapy and combination therapies.
  • Market Growth: The market for breast cancer treatments, including letrozole, is growing due to increasing incidence rates, advancements in treatment options, and improving diagnostic techniques.
  • Competitive Landscape: The market is competitive, with several major pharmaceutical companies involved, and faces restraints from side effects and generic competition.
  • Future Outlook: The market is expected to continue growing driven by increasing incidence, advancements in treatment, and the integration of digital health technologies.

FAQs

What is the primary use of FEMARA (letrozole) in breast cancer treatment?

FEMARA (letrozole) is primarily used in the treatment of hormone receptor-positive breast cancer, particularly in postmenopausal women, by inhibiting the aromatase enzyme to reduce estrogen levels.

What are the key objectives of the UCSD clinical trial involving letrozole?

The UCSD trial aims to determine whether prolonged adjuvant hormonal therapy with letrozole improves disease-free survival, overall survival, and other outcomes in postmenopausal women with estrogen receptor-positive and/or progesterone receptor-positive breast cancer.

What are the common side effects associated with long-term use of letrozole?

Common side effects include osteoporotic-related fractures, arterial thrombotic events, fatigue, dizziness, and somnolence. Long-term use can also lead to increased risks of fractures and cardiovascular events.

How does the competitive landscape affect the market for letrozole?

The market for letrozole is highly competitive with several major pharmaceutical companies involved. The presence of generic versions and emerging therapies can impact the market share of branded products like FEMARA.

What are the key drivers and restraints for the market growth of letrozole?

Key drivers include the increasing prevalence of breast cancer, advances in diagnostic techniques, and growing awareness. Restraints include side effects associated with long-term use and the presence of generic medicines.

Sources

  1. UCSF Breast Cancer Trial: Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments. [UCSF Clinical Trials][1].
  2. Menopausal Hot Flashes Market Report: Treatment of Menopausal Hot Flashes: Global Industry Trends and Regional Market Opportunities 2025-2030. [GlobeNewswire][2].
  3. FEMARA (Letrozole) Product Information: Novartis. [Novartis][3].
  4. UCSD Clinical Trial: Hormone Receptor Positive Breast Cancer - UCSD Clinical Trials. [UCSD Clinical Trials][4].

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