CLINICAL TRIALS PROFILE FOR FARESTON

All Clinical Trials for Fareston

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00044291 ↗	Phase III Study of Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer	Completed	Intarcia Therapeutics	Phase 3	2002-06-01	The purpose of this study is to determine whether the first line combination hormonal therapy of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston®), is more effective than another approved drug, letrozole (Femara®), in delaying the growth of breast cancer in postmenopausal patients with locally advanced or metastatic breast cancer, and whether the side effects of the combination are different from the side effects of letrozole.
NCT00097344 ↗	The CAT Study: Atamestane Plus Toremifene Versus Letrozole in Advanced Breast Cancer	Terminated	Intarcia Therapeutics	Phase 3	2004-12-01	The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of an experimental drug, atamestane, plus an FDA-approved drug, toremifene (Fareston®), is more effective than another approved drug, letrozole (Femara®), in delaying the growth of breast cancer, and whether the side effects of the combined hormonal therapy are different from the side effects of letrozole.
NCT00267553 ↗	Treatment and Survival Continuation Study of Atamestane Plus Toremifene vs Letrozole in Advanced Breast Cancer	Terminated	Intarcia Therapeutics	Phase 3	2005-11-01	Protocol 777-CLP-32 is the treatment and survival continuation protocol of Biomed 777-CLP-29, and will continue to compare combined hormonal therapy using the experimental aromatase inhibitor (AI) atamestane combined with the FDA-approved anti-estrogen toremifene (Fareston®), to the single agent FDA-approved aromatase inhibitor letrozole (Femara®) for the treatment of advanced breast cancer. The purpose of this study is to determine whether maximal estrogen suppression achieved via the combination of atamestane, plus toremifene (Fareston®), is more effective than letrozole (Femara®) in delaying the growth of breast cancer.
NCT00437359 ↗	Antiestrogen vs Aromatase Inhibitor After Adjuvant Chemotherapy for Breast Cancer	Terminated	Japan Breast Cancer Research Network	Phase 2	2007-05-01	To investigate the benefit of postoperative adjuvant therapy using sequential administration of the hormone, toremifene citrate (TOR) or anastrozole (ANA), after chemotherapy in breast cancer.
NCT01352091 ↗	Adjuvant AI Combined With Zoladex	Unknown status	Fudan University	Phase 3	2008-05-01	The present study is a randomized open-label -phase III study that aims to compare the efficacy of Zoladex® combined with Aromidex® for 3-2 years after SERMs (tamoxifen and Fareston®) as an adjuvant therapy for 2-3 years with the efficacy of tamoxifen up to 5 years for premenopausal breast cancer women with hormone receptor positive, lymph node positive or tumor ≥4cm. According to St. Gallen's guideline, hormone receptor positive was defined as endocrine responsive and endocrine response uncertain categories (table 3-1), and only those with ER or PR expression undetectable were considered as HR negative. The pathological evaluation of axillary lymph node could be done by sentinel node biopsy (SNB) when axillary nodes were clinically impalpable accompanied with axillary lymph node dissection (ALND) or directly through ALND when axillary nodes appeared to be positive in clinical examination. Based on the operating standard of local medical institution, identifying the numbers of lymph nodes to do the pathological evaluation and to do the dissection of I- or II-station nodes accurately.

Clinical Trial Conditions for Fareston

Condition Name

Condition Name for Fareston
Intervention	Trials
Breast Neoplasms	4
Neoplasms, Hormone-dependent	3
Breast Cancer	3
Invasive Breast Carcinoma	1

Condition MeSH

Condition MeSH for Fareston
Intervention	Trials
Breast Neoplasms	9
Neoplasms, Hormone-Dependent	3
Neoplasms	3
Breast Carcinoma In Situ	1

Clinical Trial Locations for Fareston

Trials by Country

Trials by Country for Fareston
Location	Trials
United States	49
China	22
Canada	4
Ukraine	3
Russian Federation	3

Trials by US State

Trials by US State for Fareston
Location	Trials
Washington	4
Virginia	3
Texas	3
Missouri	3
Michigan	3

Clinical Trial Progress for Fareston

Clinical Trial Phase

Clinical Trial Phase for Fareston
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	6
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Fareston
Clinical Trial Phase	Trials
Terminated	3
Completed	2
Recruiting	2

Clinical Trial Sponsors for Fareston

Sponsor Name

Sponsor Name for Fareston
Sponsor	Trials
Intarcia Therapeutics	3
Fudan University	2
Hebei Tumor Hospital	1

Sponsor Type

Sponsor Type for Fareston
Sponsor	Trials
Other	28
Industry	3
NIH	1

Clinical Trials and Efficacy of FARESTON

Introduction to FARESTON

FARESTON, also known as toremifene citrate, is a selective estrogen receptor modulator (SERM) approved by the FDA for the treatment of metastatic breast cancer in postmenopausal women. Here, we will delve into the clinical trials, efficacy, and market analysis of FARESTON.

Clinical Trials Overview

FARESTON has been extensively studied in various clinical trials to establish its efficacy and safety profile.

Phase II and III Trials

Phase II and III trials have shown that FARESTON, administered at a dose of 60 mg/day, is as effective and well-tolerated as tamoxifen, another widely used anti-estrogen for breast cancer treatment[4].

• Response Rates and Time to Progression: Studies involving postmenopausal women with estrogen receptor (ER)-positive or unknown metastatic breast cancer demonstrated response rates ranging from 32.6% to 54.3% and median times to progression of 6.3 to 12.2 months for the 60 mg/day dose[4].
• Comparison with Tamoxifen: The efficacy of FARESTON was compared to tamoxifen in several trials, showing equivalent response rates, times to progression, and survival rates. This equivalence was confirmed across multiple studies involving over 1,869 patients[1][4].

Dose Optimization

• Dose Levels: Trials were conducted at various dose levels, including 20 mg/day, 40 mg/day, and 60 mg/day. The 60 mg/day dose was found to be the most effective and is the recommended dose for clinical use[4].
• Higher Doses: Some trials explored higher doses (up to 240 mg/day), but these did not show a significant advantage over the standard 60 mg/day dose. High doses were sometimes associated with stable disease for more than 6 months, indicating some clinical benefit in tamoxifen-resistant patients[4].

Safety and Side Effects

FARESTON has a tolerable safety profile, similar to that of tamoxifen.

• Common Side Effects: The most common side effects include hot flushes and sweating, affecting more than 1 in 10 patients[1].
• Other Side Effects: Other side effects, though less common, include nausea and vertigo, particularly at higher doses[4].

Market Analysis and Projections

Current Market Position

• Approval and Licensing: FARESTON was approved by the FDA in 1997 and is currently marketed by GTx, Inc. in the United States. GTx acquired the rights to market FARESTON from Orion in 2005[3].
• Revenue Contribution: FARESTON has been a significant contributor to GTx's revenue, accounting for a substantial portion of their total revenue in previous years[3].

Market Trends and Projections

• Biopharma Industry Outlook: The biopharma industry is expected to see strong growth in 2025, driven by innovation and mergers and acquisitions. This trend could positively impact the market for drugs like FARESTON, especially if there are advancements in related therapeutic areas[5].
• Competition and Market Dynamics: The market for breast cancer treatments is competitive, with several drugs available. However, FARESTON's established efficacy and safety profile position it as a viable option for postmenopausal women with ER-positive or unknown metastatic breast cancer[1][4].

Future Prospects and Challenges

Research and Development

• Ongoing Research: While FARESTON is well-established, ongoing research in breast cancer treatments, including new SERMs and other targeted therapies, could influence its market position. Innovations in cancer vaccines and immunotherapies may also impact the treatment landscape[5].

Regulatory and Economic Factors

• Patent Cliff and M&A Activity: The biopharma industry is expected to see increased M&A activity due to the patent cliff, where several blockbuster drugs will lose exclusivity. This could lead to changes in the market dynamics and potentially affect the commercialization strategies for FARESTON[5].

Key Takeaways

• Efficacy and Safety: FARESTON is as effective and well-tolerated as tamoxifen for the treatment of metastatic breast cancer in postmenopausal women.
• Market Position: FARESTON is a significant contributor to GTx's revenue and maintains a strong position in the market for breast cancer treatments.
• Future Trends: The biopharma industry's growth, driven by innovation and M&A activity, could impact FARESTON's market prospects.

FAQs

Q: What is FARESTON used for? A: FARESTON (toremifene citrate) is used for the treatment of metastatic breast cancer in postmenopausal women with estrogen receptor (ER)-positive or unknown status.

Q: How does FARESTON compare to tamoxifen? A: Clinical trials have shown that FARESTON is as effective and well-tolerated as tamoxifen in treating metastatic breast cancer in postmenopausal women.

Q: What are the common side effects of FARESTON? A: The most common side effects of FARESTON include hot flushes and sweating.

Q: Who markets FARESTON in the United States? A: FARESTON is marketed by GTx, Inc. in the United States.

Q: What are the future prospects for FARESTON in the biopharma market? A: The future prospects for FARESTON are influenced by the overall growth of the biopharma industry, innovations in cancer treatments, and M&A activity due to the patent cliff.

Sources

1. European Medicines Agency (EMA). Fareston | European Medicines Agency (EMA).
2. Russell Investments. 2025 Annual Global Market Outlook | Russell Investments.
3. GTx, Inc. GTx, Inc. - Annual Reports.
4. Cancer Network. Phase II and III Clinical Trials of Toremifene for Metastatic Breast Cancer.
5. Genetic Engineering & Biotechnology News. Seven Biopharma Trends to Watch in 2025.