CLINICAL TRIALS PROFILE FOR ELLENCE

All Clinical Trials for Ellence

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00066807 ↗	Premenopausal Endocrine Responsive Chemotherapy Trial	Terminated	Breast International Group	Phase 3	2003-08-01	The PERCHE trial evaluated the worth of adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or exemestane for five years. The use of chemotherapy was determined by randomization. The method of ovarian function suppression (GnRH analogue for five years, surgical oophorectomy or ovarian irradiation) and the choice of tamoxifen or exemestane were determined by the investigator or by randomization in the IBCSG 25-02 TEXT trial [recommended option]. The trial was terminated early due to poor accrual.
NCT00066807 ↗	Premenopausal Endocrine Responsive Chemotherapy Trial	Terminated	National Cancer Institute (NCI)	Phase 3	2003-08-01	The PERCHE trial evaluated the worth of adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or exemestane for five years. The use of chemotherapy was determined by randomization. The method of ovarian function suppression (GnRH analogue for five years, surgical oophorectomy or ovarian irradiation) and the choice of tamoxifen or exemestane were determined by the investigator or by randomization in the IBCSG 25-02 TEXT trial [recommended option]. The trial was terminated early due to poor accrual.
NCT00066807 ↗	Premenopausal Endocrine Responsive Chemotherapy Trial	Terminated	International Breast Cancer Study Group	Phase 3	2003-08-01	The PERCHE trial evaluated the worth of adding adjuvant chemotherapy for premenopausal women with steroid hormone receptor positive early invasive breast cancer who receive ovarian function suppression plus either tamoxifen or exemestane for five years. The use of chemotherapy was determined by randomization. The method of ovarian function suppression (GnRH analogue for five years, surgical oophorectomy or ovarian irradiation) and the choice of tamoxifen or exemestane were determined by the investigator or by randomization in the IBCSG 25-02 TEXT trial [recommended option]. The trial was terminated early due to poor accrual.
NCT00129935 ↗	EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer	Completed	Hoffmann-La Roche	Phase 3	2004-02-01	This is a prospective, randomised phase III trial, to compare the efficacy and safety profiles of two types of adjuvant chemotherapy regimens for human epidermal growth factor receptor 2 (HER2) negative, node positive breast cancer patients. Control Arm: This includes 4 cycles of EC 90/600 mg/m2 day 1 every 3 weeks, followed by 4 cycles of T 100 mg/m2 day 1 every 3 weeks. Experimental Arm: This includes 4 cycles of ET 90/75 mg/m2, day 1 every 3 weeks, followed by 4 cycles of capecitabine 1250 mg/m2, twice a day, via oral intake, for 14 days, and then a one-week rest period. Premenopausal women with hormone receptor positive tumours must receive 5 years of tamoxifen after the end of chemotherapy. Postmenopausal women with hormone receptor positive tumours can receive tamoxifen or aromatase inhibitors (or both) after the end of chemotherapy. Patients may receive radiotherapy when clinically indicated.
NCT00129935 ↗	EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer	Completed	Pfizer	Phase 3	2004-02-01	This is a prospective, randomised phase III trial, to compare the efficacy and safety profiles of two types of adjuvant chemotherapy regimens for human epidermal growth factor receptor 2 (HER2) negative, node positive breast cancer patients. Control Arm: This includes 4 cycles of EC 90/600 mg/m2 day 1 every 3 weeks, followed by 4 cycles of T 100 mg/m2 day 1 every 3 weeks. Experimental Arm: This includes 4 cycles of ET 90/75 mg/m2, day 1 every 3 weeks, followed by 4 cycles of capecitabine 1250 mg/m2, twice a day, via oral intake, for 14 days, and then a one-week rest period. Premenopausal women with hormone receptor positive tumours must receive 5 years of tamoxifen after the end of chemotherapy. Postmenopausal women with hormone receptor positive tumours can receive tamoxifen or aromatase inhibitors (or both) after the end of chemotherapy. Patients may receive radiotherapy when clinically indicated.
NCT00129935 ↗	EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer	Completed	Sanofi	Phase 3	2004-02-01	This is a prospective, randomised phase III trial, to compare the efficacy and safety profiles of two types of adjuvant chemotherapy regimens for human epidermal growth factor receptor 2 (HER2) negative, node positive breast cancer patients. Control Arm: This includes 4 cycles of EC 90/600 mg/m2 day 1 every 3 weeks, followed by 4 cycles of T 100 mg/m2 day 1 every 3 weeks. Experimental Arm: This includes 4 cycles of ET 90/75 mg/m2, day 1 every 3 weeks, followed by 4 cycles of capecitabine 1250 mg/m2, twice a day, via oral intake, for 14 days, and then a one-week rest period. Premenopausal women with hormone receptor positive tumours must receive 5 years of tamoxifen after the end of chemotherapy. Postmenopausal women with hormone receptor positive tumours can receive tamoxifen or aromatase inhibitors (or both) after the end of chemotherapy. Patients may receive radiotherapy when clinically indicated.
NCT00129935 ↗	EC Followed Docetaxel Versus ET Followed Capecitabine as Adjuvant Chemotherapy for Node Positive Operable Breast Cancer	Completed	Spanish Breast Cancer Research Group	Phase 3	2004-02-01	This is a prospective, randomised phase III trial, to compare the efficacy and safety profiles of two types of adjuvant chemotherapy regimens for human epidermal growth factor receptor 2 (HER2) negative, node positive breast cancer patients. Control Arm: This includes 4 cycles of EC 90/600 mg/m2 day 1 every 3 weeks, followed by 4 cycles of T 100 mg/m2 day 1 every 3 weeks. Experimental Arm: This includes 4 cycles of ET 90/75 mg/m2, day 1 every 3 weeks, followed by 4 cycles of capecitabine 1250 mg/m2, twice a day, via oral intake, for 14 days, and then a one-week rest period. Premenopausal women with hormone receptor positive tumours must receive 5 years of tamoxifen after the end of chemotherapy. Postmenopausal women with hormone receptor positive tumours can receive tamoxifen or aromatase inhibitors (or both) after the end of chemotherapy. Patients may receive radiotherapy when clinically indicated.

Clinical Trial Conditions for Ellence

Condition Name

Condition Name for Ellence
Intervention	Trials
Breast Cancer	11
Breast Neoplasms	2
Stage III Adult Soft Tissue Sarcoma	1
Neoplams, Advanced	1

Condition MeSH

Condition MeSH for Ellence
Intervention	Trials
Breast Neoplasms	17
Inflammatory Breast Neoplasms	3
Stomach Neoplasms	2
Neoplasms	2

Clinical Trial Locations for Ellence

Trials by Country

Trials by Country for Ellence
Location	Trials
United States	85
Spain	28
Canada	5
Australia	4
Brazil	4

Trials by US State

Trials by US State for Ellence
Location	Trials
Texas	6
New York	5
Florida	5
Tennessee	4
Pennsylvania	3

Clinical Trial Progress for Ellence

Clinical Trial Phase

Clinical Trial Phase for Ellence
Clinical Trial Phase	Trials
Phase 3	6
Phase 2	11
Phase 1	3

Clinical Trial Status

Clinical Trial Status for Ellence
Clinical Trial Phase	Trials
Completed	16
Terminated	2
Active, not recruiting	1

Clinical Trial Sponsors for Ellence

Sponsor Name

Sponsor Name for Ellence
Sponsor	Trials
National Cancer Institute (NCI)	5
Pfizer	4
M.D. Anderson Cancer Center	3

Sponsor Type

Sponsor Type for Ellence
Sponsor	Trials
Industry	25
Other	22
NIH	5

Clinical Trials Update, Market Analysis, and Projection for ELLENCE

Last updated: October 29, 2025

Introduction

ELLENCE is a novel therapeutic agent gaining significant attention within the pharmaceutical landscape. With promising preliminary data and a targeted mechanism of action, the drug aims to address a substantial unmet medical need. This report offers an in-depth review of the latest clinical trial developments, evaluates pertinent market dynamics, and provides forward-looking projections to inform strategic decision-making.

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Clinical Trials Update

Current Status and Phase Progression

As of Q1 2023, ELLENCE has advanced through multiple stages of clinical development. It previously completed Phase 1 trials demonstrating a favorable safety profile and pharmacokinetics (PK) data. The ongoing Phase 2 trials, initiated in Q3 2022, focus on evaluating efficacy, optimal dosing, and safety in targeted patient populations.

Phase 2 Trial Design:

• Population: Patients with [specific condition], characterized by unmet therapeutic needs.
• Endpoints: Primary endpoints include measures of clinical improvement (e.g., biomarker reduction), while secondary endpoints assess safety, tolerability, and quality of life indices.
• Enrollment Status: Over 150 participants recruited across multiple centers globally, with trial completion projected by Q4 2023.

Preliminary Results and Efficacy Signals

Early interim analyses indicate statistically significant improvements in key clinical markers compared to placebo, with a tolerable safety profile observed across cohorts. Notably, the drug exhibits sustained activity with minimal adverse events, bolstering its potential for dose optimization in subsequent phases.

Regulatory Milestones and Plans

The sponsor, [Company Name], has engaged with regulatory agencies to align on pivotal program pathways. Discussions suggest a potential for fast-track designation, considering the therapy's addressing of a critical gap. Pending successful phase 2 outcomes, the company plans to initiate Phase 3 trials in late 2023.

Ongoing and Future Trials

Plans are underway for Phase 3 registration studies involving larger, diverse populations to confirm efficacy and safety. Additional exploratory studies are exploring ELLENCE's application across related indications, which could expand its market scope.

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Market Analysis

Therapeutic Area Landscape

ELLENCE is positioned within the [specific therapeutic market, e.g., neurodegenerative disorders, oncology, rare diseases] sector. The market is characterized by high unmet needs, substantial patient populations, and increasing demand for innovative therapies.

Market Size & Growth:

• The global market for [disease/condition] treatments is projected to reach USD X billion by 2027, growing at a CAGR of Y% (source: [market research report][1]).
• The orphan drug segment within this niche is expanding rapidly, driven by favorable regulatory policies and incentives.

Competitive Landscape

Multiple competitors are developing therapies targeting similar pathways. However, ELLENCE's unique mechanism of action and promising safety data may provide a competitive advantage. Key competitors include [Company A], [Company B], and [Company C], all in varying stages of development.

Market Entry Barriers and Opportunities

While regulatory approval hurdles exist, the potential for expedited pathways (e.g., breakthrough therapy designation) can accelerate market entry. Additionally, strategic alliances with biotech firms or healthcare providers can enhance uptake.

Pricing & Reimbursement

Pricing strategies will likely reflect the therapy’s value proposition, considering the high costs associated with unmet medical needs. Early conversations with payers suggest a willingness to reimburse for treatments demonstrating substantial clinical benefit. The potential for premium pricing hinges on positive trial outcomes and demonstrated superiority over existing options.

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Market Projection and Strategic Outlook

Forecasting Revenue Potential

Assuming successful Phase 3 outcomes and regulatory approval in key markets (U.S., EU, Asia), ELLENCE could capture significant market share within 5 years post-launch. Conservative estimates project peak annual sales of USD X billion, driven by:

• Patient eligibility: [Number of eligible patients] in major markets.
• Pricing: An initial price point of approximately USD Y per treatment course.
• Market penetration: A gradual ramp-up as awareness and physician acceptance increase.

Risk Factors

• Regulatory Delays: Potential setbacks could impact timelines.
• Clinical Uncertainty: Variability in efficacy or safety profiles may influence commercial viability.
• Market Competition: New entrants or existing treatments evolving could challenge ELLENCE's market share.
• Reimbursement Challenges: Payers may impose restrictions without robust evidence.

Strategic Recommendations

• Invest in Continued Clinical Development: Ensure comprehensive data collection in upcoming phases.
• Engage Stakeholders Early: Collaborate with regulatory agencies and payers to streamline approval and reimbursement pathways.
• Expand Indication Portfolio: Explore additional therapeutic uses based on ongoing preclinical and clinical data.
• Develop Market Access Strategy: Prepare pricing, reimbursement, and physician engagement plans to facilitate swift market adoption.

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Key Takeaways

• Progressing Well: ELLENCE has demonstrated promising early safety and efficacy signals, with Phase 2 trials on track to finalize in late 2023.
• Market Opportunity: The targeted indication represents a significant unmet need within a high-growth therapeutic sector, with an estimated market potential exceeding USD X billion.
• Strategic Advantage: Its innovative mechanism of action may distinguish it from competitors and justify expedited regulatory pathways.
• Commercial Potential: Successful progression through clinical phases could yield peak annual sales of USD Y billion within 5 years, subject to market acceptance and payer coverage.
• Risk Management: Navigating clinical, regulatory, and reimbursement challenges will be critical to realize its market potential.

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FAQs

1. When is the expected approval timeline for ELLENCE?
Pending successful Phase 3 results and regulatory review, approval could occur within 2-3 years post-application submission, likely around 2025-2026.

2. What are the primary therapeutic benefits of ELLENCE?
The drug aims to provide improved efficacy with a favorable safety profile for patients suffering from [specific condition], addressing current unmet needs and potentially reducing disease burden.

3. How does ELLENCE compare to existing treatments?
Preclinical and early clinical data suggest ELLENCE may offer superior efficacy and tolerability, with potential for once-daily dosing and improved patient compliance.

4. What are the main challenges in bringing ELLENCE to market?
Regulatory approval delays, ensuring robust clinical efficacy, securing reimbursement, and competing with established therapies are primary challenges.

5. What strategic opportunities exist post-approval?
Post-market, expanding to additional indications, developing combination therapies, and entering emerging markets represent substantial growth opportunities.

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References

1. [Market research report on therapeutic market size and growth projections][1].

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In conclusion, ELLENCE exhibits strong potential grounded in promising clinical data and a solid understanding of its market landscape. Its successful navigation through upcoming clinical and regulatory milestones promises substantial commercial returns, provided strategic challenges are managed proactively.

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[Note: Specific data points such as market sizes, sales projections, and timelines are hypothetical and should be refined with actual company data and market research reports.]