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Last Updated: March 17, 2025

CLINICAL TRIALS PROFILE FOR FARESTON


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All Clinical Trials for FARESTON

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
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.
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.
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for FARESTON

Condition Name

4331000.511.522.533.54Breast NeoplasmsNeoplasms, Hormone-DependentBreast CancerHER2/Neu Negative[disabled in preview]
Condition Name for FARESTON
Intervention Trials
Breast Neoplasms 4
Neoplasms, Hormone-Dependent 3
Breast Cancer 3
HER2/Neu Negative 1
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Condition MeSH

933100123456789Breast NeoplasmsNeoplasms, Hormone-DependentNeoplasmsBreast Carcinoma In Situ[disabled in preview]
Condition MeSH for FARESTON
Intervention Trials
Breast Neoplasms 9
Neoplasms, Hormone-Dependent 3
Neoplasms 3
Breast Carcinoma In Situ 1
[disabled in preview] 0
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Clinical Trial Locations for FARESTON

Trials by Country

+
Trials by Country for FARESTON
Location Trials
United States 49
China 22
Canada 4
Russian Federation 3
Ukraine 3
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Trials by US State

+
Trials by US State for FARESTON
Location Trials
Washington 4
California 3
Virginia 3
Texas 3
Missouri 3
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Clinical Trial Progress for FARESTON

Clinical Trial Phase

22.2%66.7%11.1%00123456Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for FARESTON
Clinical Trial Phase Trials
Phase 4 2
Phase 3 6
Phase 2 1
[disabled in preview] 0
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Clinical Trial Status

37.5%25.0%25.0%12.5%00.811.21.41.61.822.22.42.62.833.2TerminatedCompletedRecruiting[disabled in preview]
Clinical Trial Status for FARESTON
Clinical Trial Phase Trials
Terminated 3
Completed 2
Recruiting 2
[disabled in preview] 1
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Clinical Trial Sponsors for FARESTON

Sponsor Name

trials0112233Intarcia TherapeuticsFudan UniversityNational Cancer Institute (NCI)[disabled in preview]
Sponsor Name for FARESTON
Sponsor Trials
Intarcia Therapeutics 3
Fudan University 2
National Cancer Institute (NCI) 1
[disabled in preview] 1
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Sponsor Type

87.5%9.4%0051015202530OtherIndustryNIH[disabled in preview]
Sponsor Type for FARESTON
Sponsor Trials
Other 28
Industry 3
NIH 1
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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.

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