CLINICAL TRIALS PROFILE FOR LETROZOLE

505(b)(2) Clinical Trials for letrozole

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 Indication	NCT01175096 ↗	Safety and Tolerability Profile of RAD001 Daily in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor	Unknown status	Novartis	Phase 1/Phase 2	2010-07-01	RAD001 continues to be investigated as an anticancer agent on new indications such as neuroendocrine tumors (incl. carcinoid), breast cancer, liver cancer, gastric cancer and lymphoma based on its potential to act: - directly on the tumor cells by inhibiting tumor cell growth and proliferation - indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent inhibition of tumor cell HIF-1 activity and VEGF production and VEGF-induced proliferation of endothelial cells) A role for RAD001 in combination with Sandostatin LAR® Depot in the treatment of advanced carcinoid tumor is suggested by data on the regulatory role of mTOR in cell growth and protein translation and the finding that somatostatin-induced growth arrest is mediated in part by inhibition of the PI3K pathway (Charland, et al. 2001). The present study is designed to collect safety/tolerability data and evidences for efficacy of RAD001 in the medically highly unmet indication of advanced pulmonary neuroendocrine tumor in Chinese patients.
New Indication	NCT01175096 ↗	Safety and Tolerability Profile of RAD001 Daily in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor	Unknown status	Guangdong General Hospital	Phase 1/Phase 2	2010-07-01	RAD001 continues to be investigated as an anticancer agent on new indications such as neuroendocrine tumors (incl. carcinoid), breast cancer, liver cancer, gastric cancer and lymphoma based on its potential to act: - directly on the tumor cells by inhibiting tumor cell growth and proliferation - indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent inhibition of tumor cell HIF-1 activity and VEGF production and VEGF-induced proliferation of endothelial cells) A role for RAD001 in combination with Sandostatin LAR® Depot in the treatment of advanced carcinoid tumor is suggested by data on the regulatory role of mTOR in cell growth and protein translation and the finding that somatostatin-induced growth arrest is mediated in part by inhibition of the PI3K pathway (Charland, et al. 2001). The present study is designed to collect safety/tolerability data and evidences for efficacy of RAD001 in the medically highly unmet indication of advanced pulmonary neuroendocrine tumor in Chinese patients.
New Indication	NCT01175096 ↗	Safety and Tolerability Profile of RAD001 Daily in Chinese Patients With Advanced Pulmonary Neuroendocrine Tumor	Unknown status	Guangdong Provincial People's Hospital	Phase 1/Phase 2	2010-07-01	RAD001 continues to be investigated as an anticancer agent on new indications such as neuroendocrine tumors (incl. carcinoid), breast cancer, liver cancer, gastric cancer and lymphoma based on its potential to act: - directly on the tumor cells by inhibiting tumor cell growth and proliferation - indirectly by inhibiting angiogenesis leading to reduced tumor vascularity (via potent inhibition of tumor cell HIF-1 activity and VEGF production and VEGF-induced proliferation of endothelial cells) A role for RAD001 in combination with Sandostatin LAR® Depot in the treatment of advanced carcinoid tumor is suggested by data on the regulatory role of mTOR in cell growth and protein translation and the finding that somatostatin-induced growth arrest is mediated in part by inhibition of the PI3K pathway (Charland, et al. 2001). The present study is designed to collect safety/tolerability data and evidences for efficacy of RAD001 in the medically highly unmet indication of advanced pulmonary neuroendocrine tumor in Chinese patients.
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.

All Clinical Trials for letrozole

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001521 ↗	Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia	Active, not recruiting	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1995-06-08	This study was developed to determine if a combination of four drugs (flutamide, testolactone, reduced hydrocortisone dose, and fludrocortisone) can normalize growth in children with congenital adrenal hyperplasia. The study will take 60 children, boys and girls and divide them into 2 groups based on the medications given. Group one will receive the new four- drug combination. Group two will receive the standard treatment for congenital adrenal hyperplasia (hydrocortisone and fludrocortisone). The boys in group one will take the medication until the age of 14 at which time they will stop taking the four drug combination and begin receiving the standard treatment for congenital adrenal hyperplasia. Girls in group one will take the four drug combination until the age of 13, at which time they will stop and begin receiving the standard treatment for congenital adrenal hyperplasia plus flutamide. Flutamide will be given to the girls until six months after their first menstrual period. All of the children will be followed until they reach their final adult height. The effectiveness of the treatment will be determined by measuring the patient's adult height, body mass index, and bone density. ...
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.

Clinical Trial Conditions for letrozole

Condition Name

Condition Name for letrozole
Intervention	Trials
Breast Cancer	216
Metastatic Breast Cancer	39
Infertility	34
Breast Neoplasms	31

Condition MeSH

Condition MeSH for letrozole
Intervention	Trials
Breast Neoplasms	386
Infertility	51
Polycystic Ovary Syndrome	37
Carcinoma	28

Clinical Trial Locations for letrozole

Trials by Country

Trials by Country for letrozole
Location	Trials
Italy	342
Spain	226
China	199
Canada	159
Japan	125

Trials by US State

Trials by US State for letrozole
Location	Trials
California	95
Texas	94
Florida	74
Massachusetts	68
New York	68

Clinical Trial Progress for letrozole

Clinical Trial Phase

Clinical Trial Phase for letrozole
Clinical Trial Phase	Trials
Phase 4	56
Phase 3	115
Phase 2/Phase 3	22

Clinical Trial Status

Clinical Trial Status for letrozole
Clinical Trial Phase	Trials
Completed	208
Recruiting	123
Active, not recruiting	78

Clinical Trial Sponsors for letrozole

Sponsor Name

Sponsor Name for letrozole
Sponsor	Trials
Novartis Pharmaceuticals	60
National Cancer Institute (NCI)	60
Pfizer	39

Sponsor Type

Sponsor Type for letrozole
Sponsor	Trials
Other	673
Industry	294
NIH	73

Letrozole Market Analysis and Financial Projection

Letrozole: Clinical Trials, Market Analysis, and Projections

Introduction to Letrozole

Letrozole is an oral, anti-estrogen drug primarily used in the treatment of hormone receptor-positive breast cancer in postmenopausal women. It works by inhibiting the aromatase enzyme, which is responsible for the production of estrogens in the body. Here, we will delve into recent clinical trials, market analysis, and future projections for Letrozole.

Clinical Trials Update

BIG 1-98 Clinical Trial

One of the pivotal clinical trials that has significantly influenced the use of Letrozole is the BIG 1-98 trial. This trial compared Letrozole with Tamoxifen in postmenopausal women with early hormone receptor-positive breast cancer. The early results indicated that Letrozole was more effective than Tamoxifen, leading to a shift in the standard of care for this patient group. However, the long-term results were complicated by a crossover design, where patients initially on Tamoxifen were given the option to switch to Letrozole after early results showed its superiority[4].

LEE011, BYL719, and Letrozole Trial

Another significant trial involves the combination of Letrozole with two investigational agents: LEE011 (a CDK4/6 inhibitor) and BYL719 (a PI3K-alpha inhibitor). This multi-center, open-label Phase Ib study aims to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) for these combinations. The trial includes dose escalation and expansion phases to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of these combinations[1].

ALEPRO Trial

The ALEPRO trial is a Phase II, international, multicenter study evaluating the efficacy and safety of the combination of abemaciclib and Letrozole in patients with advanced, recurrent, and/or metastatic estrogen receptor-positive ovarian cancer. This trial follows a tandem two-stage design and assesses patient outcomes using quality of life questionnaires such as the EQ-5D-5L and EORTC QLQ-C30. The preliminary results indicate a clinically meaningful therapeutic benefit with an overall response rate of more than 25%[3].

Market Analysis

Current Market Status

The global Letrozole market was valued at approximately $2.6 billion in 2023. This market is expected to grow at a compound annual growth rate (CAGR) of 5.1% through 2030. The growth is driven by increasing breast cancer prevalence, growing awareness, and expanding healthcare access in emerging markets[2].

Regional Market Dynamics

• North America: This region holds the largest market share due to advanced healthcare infrastructure and high adoption of novel cancer therapies.
• Asia-Pacific: This region is anticipated to witness the fastest market growth, driven by large populations, rising disposable income, and increasing urbanization.
• Europe: Characterized by a mature market with well-established infrastructure and consumer preferences, Europe is another major region in the global Letrozole market.
• Latin America and Middle East & Africa: These regions present opportunities and challenges, with economic fluctuations and political instability in some countries impacting market dynamics[2].

Market Drivers and Restraints

Drivers

• Increasing cancer diagnoses and better detection methods.
• Expanding healthcare access in many regions.
• Use in fertility treatments, particularly for women with PCOS.
• Ongoing research into new therapeutic applications.
• Growing healthcare expenditure in developing economies[2].

Restraints

• High cost of branded Letrozole, especially in developed regions.
• Patent expiration leading to an influx of generic alternatives.
• Side effects such as hot flashes, joint pain, and bone density loss.
• Availability of other cancer treatment options like Tamoxifen[2].

Market Projections

Growth Prospects

The Letrozole market is expected to continue growing due to several factors:

• Increasing demand driven by rising breast cancer prevalence.
• Expanding use in combination therapies.
• Growing healthcare access and expenditure in emerging markets.
• The rising demand for generic versions of Letrozole, particularly in low- and middle-income countries[2].

Key Players

Major global manufacturers of Letrozole include Teva, Actavis, Mylan, Fresenius Kabi, Endo, Apotex, Sun Pharma, Hengrui, and Novartis. These companies play a significant role in shaping the market through their production and distribution capabilities[5].

Future Outlook

Emerging Markets

The Asia-Pacific region, driven by large populations and increasing cancer awareness, is anticipated to witness the fastest market growth. Latin America and the Middle East & Africa also present significant opportunities due to economic diversification efforts, urbanization, and a young population[2].

Research and Development

Ongoing clinical trials and research into new therapeutic applications of Letrozole are expected to drive market growth. The use of Letrozole in combination therapies, such as with CDK4/6 inhibitors and PI3K-alpha inhibitors, is a promising area of research[1][3].

Generic Market

The patent expiration of branded Letrozole has led to an influx of generic alternatives, which may affect market revenues but also provide more affordable options for patients in low- and middle-income countries[2].

"Letrozole is an oral, anti-estrogen drug that is used for treating postmenopausal women with breast cancer. The growth of some breast cancers in postmenopausal women is promoted by estrogens that circulate in the blood, and the adrenal glands are the main source of these circulating estrogens."[2]

Key Takeaways

• Letrozole remains a crucial drug in the treatment of hormone receptor-positive breast cancer.
• Clinical trials such as the BIG 1-98 and ALEPRO trials have significantly influenced its use and efficacy.
• The global Letrozole market is projected to grow at a CAGR of 5.1% through 2030.
• Emerging markets, particularly in the Asia-Pacific region, are expected to drive future growth.
• Ongoing research into combination therapies and generic market expansion will continue to shape the market.

FAQs

What is Letrozole used for?

Letrozole is primarily used for treating postmenopausal women with hormone receptor-positive breast cancer. It also has off-label use in fertility treatments, particularly for women with PCOS.

What were the findings of the BIG 1-98 clinical trial?

The BIG 1-98 trial showed that Letrozole was more effective than Tamoxifen in treating early hormone receptor-positive breast cancer in postmenopausal women, leading to a shift in standard care.

What is the current market size of Letrozole?

The global Letrozole market was valued at approximately $2.6 billion in 2023.

Which regions are expected to drive the future growth of the Letrozole market?

The Asia-Pacific region is anticipated to witness the fastest market growth due to large populations, rising disposable income, and increasing urbanization.

What are the major drivers of the Letrozole market growth?

Increasing cancer diagnoses, better detection methods, expanding healthcare access, and the use in fertility treatments are key drivers of the Letrozole market growth.

Sources

1. ClinicalTrials.gov: LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer.
2. OpenPR: Letrozole Market Current Status and Future Prospects till 2031.
3. International Journal of Gynecologic Cancer: ALEPRO trial.
4. Breast Cancer Trials: The BIG 1-98 Clinical Trial.
5. QYResearch: Global Letrozole Market Research Report 2024.