CLINICAL TRIALS PROFILE FOR FULVESTRANT

505(b)(2) Clinical Trials for Fulvestrant

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.
New Combination	NCT03344536 ↗	A Study of Debio 1347 Plus Fulvestrant in Patients With Metastatic Breast Cancer	Completed	Debiopharm International SA	Phase 1/Phase 2	2017-11-10	The purpose of a phase Ib study is to find out the best or maximum tolerated dose of a medication or combination of medications. Therefore, the purpose of this study is to decide the best dose of the study drug, Debio 1347, that can be given in combination with the standard hormonal drug, fulvestrant. Debio 1347 and fulvestrant could shrink the cancer but it could also cause side effects. This study tells us about the side effects of these drugs when given in this new combination, and how often they occur.
New Combination	NCT03344536 ↗	A Study of Debio 1347 Plus Fulvestrant in Patients With Metastatic Breast Cancer	Completed	Memorial Sloan Kettering Cancer Center	Phase 1/Phase 2	2017-11-10	The purpose of a phase Ib study is to find out the best or maximum tolerated dose of a medication or combination of medications. Therefore, the purpose of this study is to decide the best dose of the study drug, Debio 1347, that can be given in combination with the standard hormonal drug, fulvestrant. Debio 1347 and fulvestrant could shrink the cancer but it could also cause side effects. This study tells us about the side effects of these drugs when given in this new combination, and how often they occur.
New Combination	NCT04296942 ↗	BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT)	Completed	National Cancer Institute (NCI)	Phase 1	2021-05-04	Background: Breast cancer is the second most common cause of U.S. cancer deaths in women. Immunotherapy drugs use a person s immune system to fight cancer. Researchers want to see if a new combination of immunotherapy drugs can help treat breast cancer that has gone to places in the body outside of the breast (metastasized). Objective: To learn if a new combination of immunotherapy drugs can shrink tumors in people with metastatic breast cancer. Eligibility: Adults 18 and older who have been diagnosed with metastatic breast cancer, such as Triple Negative Breast Cancer (TNBC) or ER-/PR-/HER2+ Breast Cancer (HER2+BC) Design: Participants will be screened with: medical history physical exam disease confirmation (or tumor biopsy) tumor scans (computed tomography, magnetic resonance imaging, and/or bone scan) blood and urine tests electrocardiogram (measures the heart s electrical activity) echocardiogram (creates images of the heart). Participants will be assigned to 1 of 3 groups. The drugs they get will be based on the group they are in. Drugs are given in cycles. Each cycle = 3 weeks. Participants will be seen in clinic every 3 weeks, prior to the start of a new cycle. At each visit, participants will have an clinical exam, have blood drawn and will be asked about any side effects. They will repeat the screening tests during the study. New scans, like a CT scan, will be done every 6 weeks to see if the treatment is working. All participants will get BN-Brachyury. It is 2 different vaccines - a prime and a boost. First the priming vaccines, called MVA-BN-Brachyury help to jump start the immune system. Next the boosting vaccines, called FPV-Brachyury help to keep the immune system going. They are injected under the skin during different cycles. All participants will get M7824 (also known as Bintrafusp alfa ), which is an immunotherapy drug. Some participants will get a commonly used drug is HER2+ breast cancer called adotrastuzumab emtansine (also known as T-DM1DM1 or kadcyla). For both, a needle is inserted into a vein to give the drugs slowly. Some participants will take Entinostat weekly by mouth. It is in tablet form. Participants will keep a pill diary. Participants will continue on their assigned treatment until their cancer grows, they develop side effects or want to stop treatment. About 28 days after treatment ends, participants will have a follow-up visit or a telephone call. Then they will be contacted every 3 months for 1 year, then every 6 months for 1 year. They may have more tumor scans or continue treatment.

All Clinical Trials for Fulvestrant

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 Fulvestrant

Condition Name

Condition Name for Fulvestrant
Intervention	Trials
Breast Cancer	136
Metastatic Breast Cancer	81
Advanced Breast Cancer	33
Breast Neoplasms	25

Condition MeSH

Condition MeSH for Fulvestrant
Intervention	Trials
Breast Neoplasms	345
Neoplasms	32
Carcinoma	19
Carcinoma, Non-Small-Cell Lung	9

Clinical Trial Locations for Fulvestrant

Trials by Country

Trials by Country for Fulvestrant
Location	Trials
Italy	241
Spain	213
China	174
Canada	124
Japan	95

Trials by US State

Trials by US State for Fulvestrant
Location	Trials
California	90
Texas	81
Florida	74
New York	71
Tennessee	68

Clinical Trial Progress for Fulvestrant

Clinical Trial Phase

Clinical Trial Phase for Fulvestrant
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	67
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Fulvestrant
Clinical Trial Phase	Trials
Recruiting	114
Completed	97
Not yet recruiting	66

Clinical Trial Sponsors for Fulvestrant

Sponsor Name

Sponsor Name for Fulvestrant
Sponsor	Trials
AstraZeneca	61
Pfizer	32
National Cancer Institute (NCI)	28

Sponsor Type

Sponsor Type for Fulvestrant
Sponsor	Trials
Other	331
Industry	312
NIH	29

Fulvestrant: Clinical Trials, Market Analysis, and Projections

Introduction

Fulvestrant, a selective estrogen receptor degrader (SERD), has been a cornerstone in the treatment of hormone receptor-positive, HER2-negative advanced breast cancer, particularly in postmenopausal women. This article delves into the latest clinical trials, market analysis, and projections for fulvestrant, highlighting its efficacy, market drivers, and future outlook.

Clinical Trials Update

FAKTION Trial

The FAKTION trial, a phase 2 randomized, multicentre, double-blind, placebo-controlled study, has provided significant insights into the efficacy of combining fulvestrant with capivasertib, an AKT inhibitor. The trial involved postmenopausal women with ER-positive, HER2-negative advanced breast cancer who had relapsed or progressed on an aromatase inhibitor. The results showed that the addition of capivasertib to fulvestrant significantly improved progression-free survival (PFS) compared to fulvestrant plus placebo. The updated median PFS was 10.3 months in the fulvestrant plus capivasertib group versus 4.8 months in the fulvestrant plus placebo group[1].

CAPItello-291 Trial

The CAPItello-291 trial is an ongoing phase 3 double-blind, randomized study assessing the efficacy and safety of capivasertib plus fulvestrant versus placebo plus fulvestrant in patients with locally advanced (inoperable) or metastatic hormone receptor-positive, HER2-negative breast cancer. This trial aims to further substantiate the findings from the FAKTION trial and includes a larger patient population[3].

Other Clinical Trials

Other clinical trials, such as the phase 2 study evaluating the efficacy and tolerability of different dosing regimens of fulvestrant in postmenopausal women with ER-positive advanced breast cancer, have contributed to the understanding of fulvestrant's optimal dosing and efficacy. These studies have shown that fulvestrant remains a viable treatment option even after previous endocrine therapy[4].

Market Analysis

Market Size and Forecast

The global fulvestrant market was valued at USD 100 million in 2023 and is projected to reach USD 379.74 million by 2030, growing at a CAGR of 25.8% during the forecast period 2024-2030. This significant growth is driven by several key factors[2].

Market Drivers

• Increasing Breast Cancer Incidence: The rising incidence of breast cancer, particularly hormone receptor-positive cases, is a major driver of the fulvestrant market.
• Ageing Population: The increasing age of the population, which is associated with a higher risk of breast cancer, further drives the demand for fulvestrant.
• Effectiveness in Breast Cancer: Positive clinical results and patient responses have made fulvestrant a preferred treatment option for hormone receptor-positive breast cancer.
• Research Developments: Ongoing research and advancements in the understanding of breast cancer biology have led to the development of precision medicines like fulvestrant.
• Favorability of Targeted Therapies: Targeted therapies like fulvestrant are preferred over conventional chemotherapy due to their precision and reduced side effects.
• Combination Therapy Approaches: Fulvestrant is often combined with other medications, such as aromatase inhibitors, to enhance treatment efficacy[2].

Market Segmentation

The global fulvestrant market is segmented based on application, end-user, distribution channel, and geography.

• Application: Fulvestrant is primarily used in the treatment of metastatic breast cancer and hormone receptor-positive breast cancer.
• End-User: Hospitals, cancer treatment centers, and clinics are significant users of fulvestrant.
• Distribution Channel: Fulvestrant is distributed through hospital pharmacies, retail pharmacies, and online pharmacies.
• Geography: The market is analyzed across regions including North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa[2].

Key Players

The fulvestrant market is dominated by several key players, including:

• AstraZeneca
• Sandoz (Novartis)
• Accord Healthcare
• Amneal Pharmaceuticals
• Mylan
• Hikma Pharmaceuticals
• Teva Pharmaceutical Industries
• Zentiva
• Polpharma
• Sun Pharmaceutical Industries
• Fresenius Kabi[2].

Regulatory Approvals and Recent Developments

In November 2023, the FDA approved capivasertib (Truqap) in combination with fulvestrant for the treatment of patients with advanced HR-positive breast cancer, marking a significant milestone in the treatment landscape for this patient population[5].

Market Projections

The global breast cancer drugs market, which includes fulvestrant, is expected to surpass USD 78.61 billion by 2033, up from USD 32.93 billion in 2023. The targeted therapy segment, which includes fulvestrant, is expected to maintain its dominance during the forecast period. The hormone receptor segment, where fulvestrant is a key player, accounted for the largest share of the market in 2023[5].

Key Takeaways

• Clinical Efficacy: Fulvestrant, especially when combined with capivasertib, has shown significant improvement in progression-free survival for patients with advanced breast cancer.
• Market Growth: The fulvestrant market is projected to grow substantially due to increasing breast cancer incidence, an ageing population, and the effectiveness of targeted therapies.
• Regulatory Approvals: Recent FDA approvals for combination therapies involving fulvestrant highlight its continued importance in breast cancer treatment.
• Market Segmentation: The market is segmented based on application, end-user, distribution channel, and geography, with key players driving innovation and market expansion.

FAQs

What is the current market size of fulvestrant?

The global fulvestrant market was valued at USD 100 million in 2023[2].

What is the projected growth rate of the fulvestrant market?

The fulvestrant market is projected to grow at a CAGR of 25.8% from 2024 to 2030[2].

Which combination therapy has shown significant efficacy with fulvestrant?

The combination of fulvestrant with capivasertib has shown significant improvement in progression-free survival for patients with advanced breast cancer[1].

What are the key drivers of the fulvestrant market?

Key drivers include increasing breast cancer incidence, an ageing population, effectiveness in breast cancer treatment, research developments, favorability of targeted therapies, and combination therapy approaches[2].

Who are the major players in the fulvestrant market?

Major players include AstraZeneca, Sandoz (Novartis), Accord Healthcare, Amneal Pharmaceuticals, and others[2].

Sources

1. The Lancet Oncology: Fulvestrant plus capivasertib versus placebo after relapse or progression on an aromatase inhibitor in postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer (FAKTION): a randomised, double-blind, placebo-controlled, phase 2 trial[1].
2. Verified Market Research: Fulvestrant Market Size, Share, Scope, Trends, Growth & Forecast[2].
3. AstraZeneca Clinical Trials: CAPItello-291 - A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Fulvestrant Versus Placebo + Fulvestrant[3].
4. AstraZeneca Clinical Trials: Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant 250mg, 250mg (plus 250mg Loading regimen) and 500mg in Postmenopausal Women with ER +ve Advanced Breast Cancer Progressing or Relapsing after Previous Endocrine Therapy[4].
5. BioSpace: Breast Cancer Drugs Market Size to Surpass USD 78.61 Bn by 2033[5].

Last updated: 2025-01-01