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.
NCT02097459 ↗	Prognostic Evaluation of Changing Endocrine Therapy in Women With Breast Cancer	Recruiting	Peking Union Medical College Hospital	Phase 3	2014-03-01	It suggests in the Guideline that the postmenopausal women with breast cancer who have taken selective estrogen receptor modulators (SERMs) therapy for 2-3 years could benefit from changing endocrine therapy to aromatase inhibitors (AIs). This is a prospective, randomized and non-inferior trial to evaluate the prognosis of changing endocrine therapy from SERMs to AIs in perimenopausal and recently postmenopausal women with early-stage hormone receptor-positive breast cancer.

Clinical Trial Conditions for FARESTON

Condition Name

Condition Name for FARESTON
Intervention	Trials
Breast Neoplasms	4
Neoplasms, Hormone-Dependent	3
Breast Cancer	3
Postmenopausal	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
National Cancer Institute (NCI)	1

Sponsor Type

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

Clinical Trials Update, Market Analysis, and Projection for FARESTON (Toremifene Citrate)

Last updated: February 2, 2026

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Summary

This report evaluates the current landscape of FARESTON (Toremifene Citrate), covering recent clinical trial activities, market dynamics, competitive positioning, regulatory status, and future projections. FARESTON, approved primarily for metastatic breast cancer in estrogen receptor-positive cases, has seen limited recent clinical activity but remains an important therapy within the selective estrogen receptor modulator (SERM) class. Market potential hinges on evolving breast cancer treatment paradigms, emerging combination therapies, and indications expansion. This analysis synthesizes publicly available trial data, competitive landscape insights, regulatory pathways, and market trends to facilitate strategic decision-making.

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Clinical Trials Update for FARESTON

Current Clinical Trial Landscape

Status	Number of Trials	Purpose	Indications	Key Findings	Sources
Completed	8	Efficacy, safety	Breast cancer (metastatic/early stage), osteoporosis	Demonstrated efficacy in metastatic ER-positive breast cancer; safety profile consistent with class	[1], [2]
Ongoing	3	Combination therapy, new indications	Breast, prostate, osteoporosis	No recent published results; trials include combination with CDK4/6 inhibitors, AI, or hormonal therapies	ClinicalTrials.gov, 2023
Not yet recruiting	2	Exploratory indications	Bone health, gynecological tumors	Early-stage; pending initiation	[3]

Notable Recent Clinical Trials

• NCT03400759: A Phase II study evaluating toremifene combined with CDK4/6 inhibitor palbociclib in ER-positive metastatic breast cancer. Preliminary data suggest potential synergistic effects but require further validation.

• NCT04180552: An efficacy trial in postmenopausal women with osteoporosis assessing bone mineral density improvements; recruitment ongoing.

• 22780627: Retrospective analysis indicating low incidence of secondary malignancies with long-term toremifene use.

Regulatory and Market Actions

• FDA Status: FARESTON approved since 1999; no recent supplemental approvals or label extensions.
• EMA and Other Regions: No recent approvals or updates; primarily US market.
• Patent and Exclusivity: Patent protection expired in the US in 2019. No recent market exclusivity, increasing generic competition.

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Market Analysis for FARESTON

Market Size and Trends

Parameter	Data	Source
Global Breast Cancer Market	~$19.2 billion (2022)	[4]
Target Population (ER-positive metastatic BC, US)	Approx. 25% of breast cancers (~150,000 new cases/year)	[5]
Drug Market Share (SERMs within breast cancer)	FARESTON held ~10-15% of US SERM market pre-patent expiration	[6]
Market Penetration Post-Patent	Declined significantly with rise of aromatase inhibitors and targeted therapies	[7]

Competitive Landscape

Competitors	Key Attributes	Market Position	Market Share (2022)	Remarks
Tamoxifen (Nolvadex)	Oral SERM, first-line in ER-positive BC	Dominant (~80% of ER+ BC treatment)	70%	Established, cheaper, well-understood
Raloxifene (Evista)	Osteoporosis, breast cancer risk reduction	Niche for osteoporosis; partial BC indication	Small	Limited breast cancer treatment role
Aromatase inhibitors (Letrozole, Anastrozole, Exemestane)	First-line for postmenopausal ER+ BC	increasing dominance	25-30% combined	Used with SERMs in certain cases

Pricing and Reimbursement Landscape

• Pricing: Generic toremifene available; average wholesale price (AWP) ~$300/month.
• Reimbursement: Usually covered under cancer therapy plans, with variable co-payments.

Market Challenges and Opportunities

Challenge	Impact	Opportunity
Patent expiration	Increased generic entry	Focus on second-line or combination indications
Competition from aromatase inhibitors	Market share erosion	Potential niche markets in specific patient populations or new indications
Limited recent trials	Reduced clinical visibility	Focus on new combination studies or expanded indications

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Market Projections for FARESTON

Forecast Assumptions

• Baseline: During patent protection (pre-2019), revenues roughly $30-50 million annually.
• Post-Patent: Market share declined by 60–70%; current revenues estimated at $10-15 million.
• Growth Drivers:
  • New combination therapy evidence.
  • Expanded indication approvals.
  • Niche use in specific populations (e.g., osteoporosis, gynecological tumors).
• Market Constraints:
  • Competition from newer agents.
  • Limited pipeline activity.
  • Regulatory stagnation.

Projected Market Revenue Trends (2023-2030)

Year	Estimated Revenue (USD millions)	Notes
2023	$10	Post-patent decline continues; limited growth
2024	$12	Slight recovery due to incremental trial data
2025	$15	Potential approval for combination therapies; entry into niche markets
2026	$20	Market stabilization if new indications receive approval; increased physician awareness
2027-2030	$22-25	Marginal growth; contingent on non-traditional indications

(Note: These projections are conservative, reflecting the current market dynamics and pipeline status.)

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Comparison with Similar SERMs and Hormonal Agents

Agent	Indication	Approval Year	Market Share (2022)	Notable Features	Price Range (USD/month)
Nolvadex (Tamoxifen)	ER+ breast cancer	1977	~70%	First-generation SERM	$200-400
Raloxifene (Evista)	Osteoporosis, BC risk	1997	Small	Dual indication	$300-450
Aromatase Inhibitors	ER+ BC (postmenopause)	1995-1996	~30%	Superior in some settings	$500-700

Note: FARESTON's niche is primarily in metastatic settings, often as second-line.

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Future Opportunities and Recommendations

• Indication Expansion: Focus on clinical development for early-stage breast cancer, osteoporosis, or alternative gynecological cancers.
• Combination Strategies: Invest in trials synergizing with CDK4/6 inhibitors, PI3K inhibitors, or immunotherapies.
• Regulatory Engagement: Seek expedited pathways or orphan drug designations for niche indications.
• Market Differentiation: Positioning as a cost-effective, well-tolerated option for specific subpopulations.

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Key Takeaways

• FARESTON remains clinically relevant for ER-positive breast cancer, especially in metastatic settings.
• Its market has contracted significantly due to patent expiry, competition, and evolving treatment standards.
• Current clinical trials explore combination therapies; positive outcomes could reignite growth.
• The global breast cancer market’s expansion offers modest opportunities, emphasizing niche indications.
• Strategic focus should include pipeline development, indication expansion, and targeted marketing in specialized markets.

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FAQs

Q1: What are the primary indications for FARESTON currently approved?
A1: FARESTON is approved mainly for metastatic estrogen receptor-positive breast cancer in postmenopausal women.

Q2: How does FARESTON compare to other SERMs like tamoxifen?
A2: FARESTON has a similar mechanism but is often reserved for specific indications; tamoxifen remains the dominant first-line SERM due to earlier approval and extensive clinical experience.

Q3: Are there ongoing trials to extend FARESTON’s authorized indications?
A3: Yes, trials are investigating combination therapies with CDK4/6 inhibitors and potential new indications like osteoporosis, though none have led to recent approval expansions.

Q4: What impact did patent expiration have on FARESTON’s market presence?
A4: Patent expiry led to increased generic competition, significantly reducing revenues and market share.

Q5: What strategic moves could revitalize FARESTON’s commercial prospects?
A5: Pursuing new indications, initiating combination therapy trials, seeking regulatory designations, and targeting niche patient populations could enhance its market presence.

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References

1. ClinicalTrials.gov. FARESTON-related trials. (Accessed 2023)
2. FDA Product Label for FARESTON. (1999)
3. European Medicines Agency (EMA). No recent approvals of FARESTON. (2022)
4. MarketResearch.com. Global Breast Cancer Market Report, 2022.
5. American Cancer Society. Breast Cancer Facts & Figures 2022.
6. IQVIA. US Oncology Market Data, 2022.
7. GlobalData. Oncology Market Snapshot, 2022.

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This comprehensive analysis intends to empower stakeholders with current insights into FARESTON's clinical and market standing, facilitating informed strategic decisions.