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	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.
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

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.

Clinical Trial Conditions for FASLODEX

Condition Name

Condition Name for FASLODEX
Intervention	Trials
Breast Cancer	59
Metastatic Breast Cancer	30
Advanced Breast Cancer	13
Breast Neoplasms	12

Condition MeSH

Condition MeSH for FASLODEX
Intervention	Trials
Breast Neoplasms	140
Neoplasms	15
Carcinoma	15
Carcinoma, Non-Small-Cell Lung	5

Clinical Trial Locations for FASLODEX

Trials by Country

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−

Trials by Country for FASLODEX
Location	Trials
United States	677
Spain	81
Italy	80
Canada	50
Japan	49

Trials by US State

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−

Trials by US State for FASLODEX
Location	Trials
California	40
Texas	36
Florida	33
New York	31
Massachusetts	30

Clinical Trial Progress for FASLODEX

Clinical Trial Phase

Clinical Trial Phase for FASLODEX
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	28
Phase 2/Phase 3	1

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	145
Industry	139
NIH	22

FASLODEX: Clinical Trials, Market Analysis, and Projections

Introduction to FASLODEX

FASLODEX, also known as fulvestrant, is a crucial drug in the treatment of hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. It is an estrogen receptor antagonist that works by binding to estrogen receptors and downregulating the ER protein in breast cancer cells[5].

Mechanism of Action and Dosage

FASLODEX acts as a reversible inhibitor of the growth of tamoxifen-resistant and estrogen-sensitive human breast cancer cell lines. It binds to the estrogen receptor with an affinity comparable to that of estradiol, thereby downregulating the ER protein in human breast cancer cells. The drug is administered via intramuscular injection, typically at a dose of 500mg, and can be used alone as the first treatment for postmenopausal women with HR-positive, HER2-negative advanced-stage breast cancer that has not been treated with hormonal therapy[5].

Clinical Trials Update

CAPItello-291 Trial

In a significant clinical trial update, the CAPItello-291 Phase III trial evaluated the combination of capivasertib, an AKT inhibitor, with FASLODEX in patients with HR-positive, HER2-low or negative locally advanced or metastatic breast cancer. The trial demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to placebo plus FASLODEX. This combination showed benefits in both the overall patient population and in a prespecified biomarker subgroup of patients with qualifying alterations in the PIK3CA, AKT1, or PTEN genes[1].

SERENA-2 Trial

The SERENA-2 Phase II trial compared AstraZeneca’s next-generation oral selective estrogen receptor degrader (ngSERD) camizestrant with FASLODEX in post-menopausal patients with ER-positive locally advanced or metastatic breast cancer. Camizestrant significantly improved PFS at both 75mg and 150mg dose levels versus FASLODEX, highlighting its potential as a future treatment option for HR-positive breast cancer[4].

Market Analysis

Current Market Scenario

The market for FASLODEX is influenced by several factors, including the increasing incidence of breast cancer, the high unmet need in the ESR1 mutation space, and the acceptance of newer therapies. FASLODEX has been a cornerstone in the treatment of HR-positive, HER2-negative breast cancer, but it is facing competition from emerging oral selective estrogen receptor degraders (SERDs) such as ORSERDU, camizestrant, giredestrant, and imlunestrant[2].

Market Projections

The SERD market, which includes FASLODEX, is expected to exhibit remarkable growth from 2020 to 2034. According to DelveInsight's analysis, the total market size of SERDs in the 7MM (the United States, EU4, the United Kingdom, and Japan) is anticipated to rise significantly due to the strong uptake of ORSERDU and the expected entry of other oral SERDs. By 2034, these therapies are estimated to generate approximately USD 3 billion in revenue in the US alone for metastatic settings[2].

Competitive Landscape

The market for ER-positive, HER2-negative breast cancer is becoming increasingly competitive with the emergence of new therapies. FASLODEX, although still a dominant player, faces challenges from next-generation oral SERDs like camizestrant, which has shown promising results in clinical trials. Other emerging products, such as giredestrant and imlunestrant, are also expected to impact the market significantly[3].

Regulatory Milestones and Development Activities

FASLODEX has several regulatory milestones, including its approval for the treatment of HR-positive, HER2-negative advanced breast cancer in postmenopausal women. The drug has undergone extensive research and development activities, including various clinical trials to assess its efficacy and safety. The generics of FASLODEX entered the US market in 2019, which has also influenced its market dynamics[5].

Future Market Assessments

Forecasted Sales

The forecasted sales data for FASLODEX from 2023 to 2032 indicate a changing market scenario due to the introduction of new therapies and the increasing incidence of breast cancer. Despite the competition, FASLODEX is expected to maintain a significant market share, although its dominance may be challenged by the strong performance of newer oral SERDs[5].

SWOT Analysis

A SWOT analysis of FASLODEX highlights its strengths, such as its established position in the market and its efficacy in treating HR-positive breast cancer. However, it also reveals weaknesses, including the potential competition from emerging therapies and the impact of generic versions on its market share. Opportunities include the expanding global healthcare spending and the need for effective treatments in the ESR1 mutation space. Threats include the rapid development and approval of new SERDs and the potential for market share erosion[3].

Emerging Therapies

The landscape of ER-positive, HER2-negative breast cancer treatment is evolving rapidly with the development of new oral SERDs. Camizestrant, giredestrant, and imlunestrant are among the emerging therapies that are expected to give tough competition to FASLODEX. These next-generation SERDs offer improved efficacy and safety profiles, which could significantly impact the market dynamics in the coming years[2][4].

Key Takeaways

• Clinical Efficacy: FASLODEX has demonstrated significant clinical efficacy in treating HR-positive, HER2-negative breast cancer, but it faces competition from newer oral SERDs.
• Market Growth: The SERD market is expected to grow significantly due to the increasing incidence of breast cancer and the strong performance of emerging therapies.
• Competitive Landscape: The market is becoming increasingly competitive with the emergence of next-generation oral SERDs.
• Regulatory and Development Activities: FASLODEX has several regulatory milestones and ongoing development activities, but its market share may be impacted by generic versions and new therapies.
• Future Projections: Despite competition, FASLODEX is expected to maintain a significant market share, with forecasted sales indicating a changing market scenario.

FAQs

What is FASLODEX used for?

FASLODEX (fulvestrant) is used for the treatment of hormone receptor-positive (HR-positive), human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women[5].

How does FASLODEX work?

FASLODEX works by binding to estrogen receptors and downregulating the ER protein in breast cancer cells, thereby inhibiting the growth of cancer cells[5].

What are the recent clinical trial updates for FASLODEX?

Recent clinical trials, such as the CAPItello-291 and SERENA-2 trials, have evaluated FASLODEX in combination with other therapies and compared it with newer oral SERDs, showing mixed results but highlighting the potential of combination therapies and next-generation SERDs[1][4].

What is the market projection for FASLODEX?

The market for FASLODEX is expected to grow, but it will face significant competition from emerging oral SERDs. By 2034, the total market size of SERDs in the 7MM is expected to rise significantly, with FASLODEX maintaining a significant but potentially reduced market share[2].

What are the emerging therapies competing with FASLODEX?

Emerging therapies include next-generation oral SERDs such as camizestrant, giredestrant, and imlunestrant, which have shown promising results in clinical trials and are expected to impact the market significantly[2][4].

Sources

1. AstraZeneca Press Release: "Capivasertib plus Faslodex significantly improved progression-free survival in patients with HR-positive, HER2-low or negative locally advanced or metastatic breast cancer"[1].
2. GlobeNewswire: "SERD Market is Predicted to Exhibit Remarkable Growth Owing to the Usage of Faslodex in Combination, Strong Performance of ORSERDU, and Speedy Progress of Other Oral SERDs"[2].
3. Research and Markets: "FASLODEX Drug Insight and Market Forecast - Research and Markets"[3].
4. AstraZeneca Press Release: "Camizestrant significantly improved progression-free survival vs. Faslodex in SERENA-2 Phase II trial in advanced ER-positive breast cancer"[4].
5. GII Research: "FASLODEX Drug Insight and Market Forecast - 2032"[5].