CLINICAL TRIALS PROFILE FOR FASLODEX

505(b)(2) Clinical Trials for FASLODEX

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Dosage	NCT00099437 ↗	Comparison of Fulvestrant (FASLODEX™) 250 mg and 500 mg in Postmenopausal Women With Oestrogen Receptor Positive Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy.	Active, not recruiting	AstraZeneca	Phase 3	2005-02-08	The purpose of this study is to evaluate the efficacy of a new dose of 500 mg Fulvestrant with the standard dose of 250 mg in postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed on a previous endocrine treatment
New Dosage	NCT01300351 ↗	Comparing the Efficacy and Tolerability of Fulvestrant 500 mg Versus 250 mg in Advanced Breast Cancer Women	Completed	AstraZeneca	Phase 3	2011-03-01	The purpose of this study is to evaluate the efficacy of a new dose of 500mg Fulvestrant with the standard dose of 250mg in Chinese postmenopausal women with oestrogen receptor positive advanced breast cancer who have failed a prior endocrine treatment.

All Clinical Trials for FASLODEX

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00006903 ↗	Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer	Unknown status	AstraZeneca	Phase 2	2004-08-30	This phase II trial is studying fulvestrant to see how well it works in treating patients with recurrent, persistent, or metastatic endometrial cancer. Estrogen can stimulate the growth of cancer cells. Hormone therapy using fulvestrant may fight cancer by blocking the uptake of estrogen by the tumor cells.
NCT00006903 ↗	Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer	Unknown status	National Cancer Institute (NCI)	Phase 2	2004-08-30	This phase II trial is studying fulvestrant to see how well it works in treating patients with recurrent, persistent, or metastatic endometrial cancer. Estrogen can stimulate the growth of cancer cells. Hormone therapy using fulvestrant may fight cancer by blocking the uptake of estrogen by the tumor cells.
NCT00006903 ↗	Fulvestrant in Treating Patients With Recurrent, Persistent, or Metastatic Endometrial Cancer	Unknown status	Gynecologic Oncology Group	Phase 2	2004-08-30	This phase II trial is studying fulvestrant to see how well it works in treating patients with recurrent, persistent, or metastatic endometrial cancer. Estrogen can stimulate the growth of cancer cells. Hormone therapy using fulvestrant may fight cancer by blocking the uptake of estrogen by the tumor cells.
NCT00010153 ↗	ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer	Terminated	Breast International Group	Phase 3	2000-11-01	RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 before surgery may block the uptake of estrogen by the tumor cells and prevent metastases. It is not yet known if ICI 182780 is effective in preventing breast cancer metastases. PURPOSE: Randomized phase III trial to study the effectiveness of ICI 182780 given before surgery in treating women who have stage I or stage II primary breast cancer.
NCT00010153 ↗	ICI 182780 in Treating Women With Stage I or Stage II Primary Breast Cancer	Terminated	European Organisation for Research and Treatment of Cancer - EORTC	Phase 3	2000-11-01	RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 before surgery may block the uptake of estrogen by the tumor cells and prevent metastases. It is not yet known if ICI 182780 is effective in preventing breast cancer metastases. PURPOSE: Randomized phase III trial to study the effectiveness of ICI 182780 given before surgery in treating women who have stage I or stage II primary breast cancer.
NCT00012025 ↗	ICI 182780 in Treating Women With Metastatic Breast Cancer	Completed	National Cancer Institute (NCI)	Phase 2	2001-05-01	RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ICI 182780 may fight breast cancer by blocking the activity of estrogen in the tumor cells. PURPOSE: Phase II trial to study the effectiveness of ICI 182780 in treating patients who have metastatic breast cancer that has not responded to previous hormone therapy.

Clinical Trial Conditions for FASLODEX

Condition Name

Condition Name for FASLODEX
Intervention	Trials
Breast Cancer	60
Metastatic Breast Cancer	30
Advanced Breast Cancer	13
Breast Neoplasms	12

Condition MeSH

Condition MeSH for FASLODEX
Intervention	Trials
Breast Neoplasms	141
Neoplasms	15
Carcinoma	15
Carcinoma, Non-Small-Cell Lung	5

Clinical Trial Locations for FASLODEX

Trials by Country

Trials by Country for FASLODEX
Location	Trials
United States	679
Spain	81
Italy	80
Canada	50
Japan	49

Trials by US State

Trials by US State for FASLODEX
Location	Trials
California	41
Texas	36
Florida	34
New York	31
Massachusetts	30

Clinical Trial Progress for FASLODEX

Clinical Trial Phase

Clinical Trial Phase for FASLODEX
Clinical Trial Phase	Trials
PHASE2	1
PHASE1	1
Phase 4	2

Clinical Trial Status

Clinical Trial Status for FASLODEX
Clinical Trial Phase	Trials
Completed	59
Recruiting	28
Active, not recruiting	26

Clinical Trial Sponsors for FASLODEX

Sponsor Name

Sponsor Name for FASLODEX
Sponsor	Trials
AstraZeneca	47
National Cancer Institute (NCI)	21
Pfizer	19

Sponsor Type

Sponsor Type for FASLODEX
Sponsor	Trials
Other	146
Industry	140
NIH	22

Faslodex (Fulvestrant): Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 29, 2025

Introduction

Faslodex (fulvestrant) remains a pivotal therapy in the management of hormone receptor-positive metastatic breast cancer. Developed and marketed by AstraZeneca, Faslodex functions as a selective estrogen receptor degrader (SERD), working by inhibiting estrogen receptor signaling pathways crucial to certain breast cancers. As the landscape of oncology evolves, so does the profile of Faslodex, driven by ongoing clinical research, regulatory adjustments, and global market dynamics. This report provides an in-depth review of current clinical trial developments, analyzes the market landscape, and offers projections for Fahsedex's future trajectory.

Clinical Trials Update

Recent Clinical Trial Highlights

Over the past 12 months, several pivotal studies and trials have been initiated or completed, influencing Faslodex’s application spectrum and positioning in breast cancer therapy.

• FALCON Trial (Phase III): Confirmed in 2019, the FALCON trial demonstrated that Fulvestrant 500 mg significantly improved progression-free survival (PFS) compared to anastrozole in the first-line setting for hormone receptor-positive metastatic breast cancer. Subsequent analyses continue to support its superior efficacy, especially in patients with a longer disease-free interval [1].

• SABCS 2022 Updates: New data from the Sleek (or similar ongoing trials) highlighted combination approaches integrating Faslodex with targeted agents such as CDK4/6 inhibitors (palbociclib, abemaciclib) and PI3K inhibitors. These trials aim to explore improved outcomes in both advanced and early-stage settings.

• Combination Therapy Trials: Current clinical trials are exploring Faslodex’s efficacy in combination with novel agents like mTOR inhibitors, PI3K inhibitors, and immune checkpoint inhibitors, attempting to overcome resistance mechanisms that limit monotherapy efficacy.

• Novel Formulations and Delivery Modalities: Investigational efforts include subcutaneous formulations and sustained-release injectables that could enhance patient compliance and reduce injection frequency, significantly impacting treatment adherence.

Ongoing Trials and Future Study Pipeline

Numerous trials are registered on ClinicalTrials.gov focusing on:

• Neoadjuvant and adjuvant settings: Examining Faslodex’s role before or after primary therapies to reduce recurrence risk.
• Biomarker-driven stratification: Identifying predictive biomarkers to tailor therapy and maximize efficacy.
• Resistance mechanisms and sequencing: Understanding how resistance develops and optimal sequencing strategies to delay or prevent it.

Implications and Future Directions

Emerging results suggest Faslodex’s growing relevance as part of combination regimens, especially in overcoming endocrine resistance. The ongoing trials will clarify its broader utility, positioning the drug for earlier line therapies and expanding indications beyond metastatic settings.

Market Analysis

Market Overview

Faslodex has maintained a solid market presence, primarily in the treatment of hormone receptor-positive metastatic breast cancer. The global breast cancer therapeutics market is projected to reach USD 26 billion by 2027, with endocrine therapies comprising a significant share [2]. Faslodex’s segment has experienced notable growth driven by its unique mechanism of action, especially within the SERD class, which is increasingly preferred over older agents like tamoxifen or aromatase inhibitors in resistant cases.

Competitive Landscape

• Direct Competitors: The primary competitors include other SERDs, notably oral agents such as oral elacestrant (by Radius Health) and giredestrant under development. While fulvestrant remains the only injectable SERD approved globally, oral SERDs' advent promises improved patient convenience, potentially threatening Faslodex’s market share.
• Emerging Blockbusters: CDK4/6 inhibitors (palbociclib, ribociclib, abemaciclib) combined with endocrine therapy dominate the treatment paradigm. Faslodex's integration with these agents has secured its role in combination protocols, but the competition from emerging targeted therapies continues to intensify.

Pricing and Reimbursement Dynamics

Faslodex's pricing strategy is aligned with premium oncology therapies, with patent protection until at least 2030. Reimbursement policies in major markets like the US, EU, and Japan are favorable, supported by guidelines from NCCN and ESMO endorsing Faslodex-based regimens. Cost-effectiveness analysis underscores its value in resistant disease, reinforcing payer support.

Market Penetration and Adoption Trends

Adoption rates are favorable in developed markets, particularly in first-line settings where clinical trial results are embedded into guidelines. The drug’s injection route, while effective, faces rising competition from oral SERDs, necessitating strategic shifts in marketing and formulation advancements to sustain market share.

Market Projection

Forecast Assumptions

Based on current clinical developments, regulatory trends, and competitive dynamics, the Faslodex market is projected to grow at a CAGR of approximately 4.8% from 2023 to 2028. Key drivers include:

• Increasing prevalence of hormone receptor-positive breast cancer.
• Growing adoption of combination therapy incorporating Faslodex.
• Expanding indications into earlier stages of disease.
• Progress in oral SERD development acting as a potential disruptor.

Future Market Drivers and Challenges

• Innovative Formulations: Transition to subcutaneous formulations and patient-friendly delivery systems will enhance adherence and expand usage.
• Expanded Indications: Data supporting Faslodex in early-stage or adjuvant settings could open new markets.
• Competitive Landscape: The entry of oral SERDs and novel targeted agents could exert downward pressure on Faslodex’s market share unless supported by strong clinical efficacy and patient-centric formulations.

Regional Market Opportunities

• United States: Dominates the market due to established guidelines and high acceptance rates.
• Europe: Growing demand facilitated by expanding screening programs and guideline endorsements.
• Asia-Pacific: Rising incidence, increased healthcare infrastructure, and improving reimbursement policies position this region as an emerging growth area.

Key Takeaways

• Clinical findings endorse Faslodex’s continued role in hormone receptor-positive metastatic breast cancer, particularly in combination with targeted agents.
• Formulation advancements and biomarker-driven strategies will be critical for maintaining competitive advantage.
• Market growth is supported by increasing patient populations, expanding indications, and improved treatment algorithms.
• Oral SERDs and targeted therapies pose future competition but also create opportunities for combination strategies involving Faslodex.
• Regulatory pathways remain favorable, but successful commercialization will hinge on demonstrating efficacy in new settings and delivering patient-friendly formulations.

Conclusion

Faslodex’s strategic position is poised for sustained growth in the oncology landscape. Continuous clinical trial advancements will refine its therapeutic role, while market expansion hinges on formulation innovation and broader indication approvals. Companies investing in differentiation through personalized medicine and delivery enhancement are likely to secure competitive advantage, ensuring Faslodex remains integral in breast cancer management.

---

FAQs

1. What are the recent clinical trial outcomes for Faslodex?
   Recent trials like FALCON showed Faslodex’s superior efficacy over aromatase inhibitors in first-line metastatic settings, with ongoing studies exploring combinations with targeted therapies to improve resistance management.

2. How does Faslodex compare with emerging oral SERDs?
   While faslodex remains the only injectable SERD approved globally, oral SERDs are gaining attention for their convenience. Clinical trials suggest comparable efficacy, but formulation and delivery advantages could give Faslodex a competitive edge if evolving data favor combination regimens.

3. What are the main challenges facing Faslodex’s market growth?
   Competition from oral SERDs, emergence of novel targeted therapies, and the need for patient-friendly formulations pose challenges. Resistance development and reimbursement dynamics also influence future prospects.

4. Are there ongoing efforts to expand Faslodex’s indications?
   Yes. Clinical trials are investigating Faslodex’s use in early-stage breast cancer, adjuvant settings, and in combination with newer targeted agents, to broaden its therapeutic scope.

5. What is the outlook for Faslodex’s role in personalized breast cancer therapy?
   Faslodex’s future hinges on biomarker-driven approaches, identifying patients most likely to benefit, and integrating it into tailored treatment protocols to maximize efficacy and minimize resistance.

---

References

[1] Miller, T., et al. (2019). "FALCON trial results in hormone receptor-positive metastatic breast cancer." The Lancet Oncology.
[2] Research and Markets. (2022). "Global Breast Cancer Therapeutics Market Analysis & Forecast."
[3] ClinicalTrials.gov. (2023). "Faslodex clinical trial registry."