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.
NCT02344940 ↗	Safety of Toremifene and Tamoxifen Therapy in Premenopausal Patients With Operable Breast Cancer	Completed	Shanghai Jiao Tong University School of Medicine	Phase 4	2014-12-01	To compare the safety of toremifene and tamoxifen therapy in premenopausal patients with operable breast cancer by monitoring gynecological abnormality,blood lipid level,hepatic abnormality,estrogen level and perimenopausal symptoms.

Clinical Trial Conditions for FARESTON

Condition Name

Condition Name for FARESTON
Intervention	Trials
Breast Neoplasms	4
Breast Cancer	3
Neoplasms, Hormone-Dependent	3
Stage IA Breast Cancer	1

Condition MeSH

Condition MeSH for FARESTON
Intervention	Trials
Breast Neoplasms	9
Neoplasms	3
Neoplasms, Hormone-Dependent	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
Russian Federation	3
Ukraine	3

Trials by US State

Trials by US State for FARESTON
Location	Trials
Washington	4
Missouri	3
Michigan	3
California	3
Virginia	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
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	1

Sponsor Type

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

Last updated: May 3, 2026

What do current clinical trials, market access, and forecast indicate for Fareston (toremifene)?

What is Fareston’s current clinical trial footprint?

Fareston (toremifene) is an established selective estrogen receptor modulator (SERM). As of the available public record, the primary clinical evidence base is historical; there is no clear, ongoing, high-readout late-stage development program that would justify a fresh near-term efficacy or safety inflection. Public trial activity that exists tends to be investigator-led or small-sample studies (often comparative, mechanistic, or regimen-focused) rather than phase-3 registrational work with a clearly articulated timeline.

Result: For forecasting and investment-grade planning, the practical assumption is that Fareston’s near-term value is driven by market dynamics and indication maintenance rather than a new blockbuster readout.

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What is the commercial market structure for Fareston?

Fareston’s commercial profile depends on: (i) estrogen receptor targeted oncology usage, (ii) geography-specific reimbursement and guideline positioning, and (iii) generic erosion timing in each market.

Key commercial attributes that typically govern SERM economics:

1. Oncology-linked demand is guideline dependent
   • Toremifene is used in hormone receptor targeted settings, most commonly in breast cancer contexts where SERMs remain an accepted option in specific lines of therapy.
2. Generic entry drives price pressure
   • For mature, off-patent small molecules, volume can persist while net price declines sharply after generic adoption.
3. Formulary placement and reimbursement drive utilization
   • Even when clinical use continues, payer policies often shift to lower-cost alternatives within the same pharmacologic class.

Result: Fareston’s revenue outlook is usually volume-stable but value-softening in markets where generics or therapeutically interchangeable products gain share.

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Where does Fareston still monetize most effectively?

Fareston monetizes best where three conditions coincide:

• SERMs maintain a place in relevant treatment algorithms (line of therapy and biomarker-defined eligibility).
• Reimbursement pathways remain open for toremifene-based regimens.
• Local competition is limited or priced less aggressively than in higher-competition markets.

Because this is a mature product, the highest incremental gains typically come from:

• retaining formulary position
• managing channel inventory
• supporting physician switching constraints via patient continuity and brand reputation (where applicable)

Result: The revenue engine is “maintain share and prevent deeper net price erosion,” not “grow via major new indication.”

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What is the basis for a market projection if no major late-stage program is evident?

A robust projection for mature, mature-oncology branded products typically uses a “price-volume” framework:

1. Volume trajectory
   • Maintained by continuity of SERM prescribing, patient turnover, and ongoing eligibility.
2. Net price trajectory
   • Declines as generic competition increases, with differential timing by country.
3. Reimbursement volatility
   • Drives faster or slower utilization changes than clinical demand alone.

Projection logic for Fareston:

• In the absence of a new registrational expansion, expect modest volume changes and material net price compression where generics are active or where interchangeability accelerates.
• The forecast range tightens where the product has stable reimbursement status and stable competitive structure.

Result: A “down-market” revenue profile is the default for mature SERMs in competitive geographies unless there is a region-specific competitive hold or payer protection.

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How should investors and R&D leaders position Fareston specifically?

For business planning, Fareston should be treated as a cash-flow and stewardship asset rather than a development pipeline bet unless a credible late-stage program emerges.

Actionable positioning:

• Commercial due diligence focus: generic landscape by geography, formulary access stability, and net price vs list price dynamics.
• Clinical due diligence focus: confirm whether any registrational-grade trials exist that could change indication scope, contraindication profile, or label language.
• Lifecycle risk focus: track competitor launches and payer switching behavior after interchangeability updates.

Result: The competitive threat is primarily pricing and substitution, with clinical upside limited to label maintenance and incremental real-world utilization rather than new efficacy outcomes.

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Key takeaways

• Fareston’s clinical value proposition is dominated by historical evidence; there is no clear, registrational late-stage development signal driving a near-term label change.
• Commercial performance is primarily a function of reimbursement and generic-driven net price erosion, with volume relatively more stable than price.
• Forecasts should use a price-volume framework and treat the asset as stewardship and cash-flow dependent unless new late-stage trial outcomes appear.

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FAQs

1) What drives Fareston demand most today?

Formulary coverage and guideline placement for SERM-eligible oncology settings, with demand sustained by patient turnover rather than new label-led adoption.

2) Is Fareston likely to grow via new clinical outcomes?

The current development posture appears oriented away from a near-term registrational breakthrough, so growth is more likely to come from maintaining access than from new trial readouts.

3) What is the biggest economic risk to Fareston?

Generic competition and payer switching behavior that reduce net price faster than volume.

4) Where can brand SERMs like Fareston still outperform?

Where payer protection, formulary persistence, or competitive intensity delay deeper net price erosion relative to other markets.

5) What is the correct forecasting model for a mature SERM like Fareston?

Price-volume with geography-specific generic penetration timing, plus reimbursement stability assumptions.

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References

[1] ClinicalTrials.gov. “Search results for toremifene (FARESTON).” https://clinicaltrials.gov/
[2] FDA. “FARESTON (toremifene citrate) prescribing information.” https://www.accessdata.fda.gov/
[3] EMA. “Fareston (toremifene) EPAR and product information.” https://www.ema.europa.eu/