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.
New Combination	NCT05721443 ↗	Cetuximab Plus Dalpicilib in Patients With HPV Negative, PD-1 Resistant R/M HNSCC	Recruiting	Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University	Phase 2	2023-04-01	This study is the first clinical study in PD-1 resistant patients with head and neck squamous cell carcinoma with drugs targeting EGFR signaling pathway combined with CDK4/6 inhibitors, which explores the new combination therapies urgently needed in clinical practice and lays a foundation for subsequent studies, with important scientific research significance and clinical value.

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.
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 FULVESTRANT

Condition Name

Condition Name for FULVESTRANT
Intervention	Trials
Breast Cancer	157
Metastatic Breast Cancer	91
Advanced Breast Cancer	44
Breast Neoplasms	27

Condition MeSH

Condition MeSH for FULVESTRANT
Intervention	Trials
Breast Neoplasms	389
Neoplasms	36
Carcinoma	19
Neoplasm Metastasis	16

Clinical Trial Locations for FULVESTRANT

Trials by Country

Trials by Country for FULVESTRANT
Location	Trials
Italy	244
China	228
Spain	220
Canada	131
Japan	100

Trials by US State

Trials by US State for FULVESTRANT
Location	Trials
California	104
Texas	104
Florida	87
New York	79
Massachusetts	78

Clinical Trial Progress for FULVESTRANT

Clinical Trial Phase

Clinical Trial Phase for FULVESTRANT
Clinical Trial Phase	Trials
PHASE3	15
PHASE2	21
PHASE1	32

Clinical Trial Status

Clinical Trial Status for FULVESTRANT
Clinical Trial Phase	Trials
RECRUITING	154
Completed	97
Not yet recruiting	66

Clinical Trial Sponsors for FULVESTRANT

Sponsor Name

Sponsor Name for FULVESTRANT
Sponsor	Trials
AstraZeneca	68
Pfizer	36
Novartis Pharmaceuticals	28

Sponsor Type

Sponsor Type for FULVESTRANT
Sponsor	Trials
Industry	365
Other	362
NIH	29

Fulvestrant: Clinical Trial Landscape, Market Dynamics, and Future Outlook

Last updated: February 19, 2026

Fulvestrant, a selective estrogen receptor degrader (SERD), is an endocrine therapy for hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer. Its established efficacy in postmenopausal women with disease progression following prior antiestrogen therapy underpins its current market position. Recent clinical trial data and evolving treatment guidelines are shaping its future utility, particularly in combination therapies and in comparison to emerging oral SERDs.

What are the current indications and approved uses for Fulvestrant?

Fulvestrant is approved for the treatment of postmenopausal women with hormone receptor-positive (HR+), HER2-negative advanced breast cancer. This indication is typically for patients who have experienced disease progression following or relapse after prior endocrine therapy. The drug functions by binding to the estrogen receptor (ER), inhibiting its dimerization, blocking its nuclear localization, and ultimately leading to ER degradation. This mechanism effectively reduces the proliferation of ER-positive breast cancer cells.

The most common approved indication is detailed by regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). For instance, the FDA label for Faslodex (fulvestrant) specifies its use for the treatment of postmenopausal women with estrogen receptor (ER)-positive, HER2-negative advanced breast cancer, with disease progression following or relapse after antiestrogen therapy. This therapy is not intended for women who have had prior chemotherapy for metastatic disease unless they had disease progression during or within 12 months of completing adjuvant (or post-operative) chemotherapy.

What are the key ongoing and recently completed clinical trials for Fulvestrant?

The clinical trial landscape for fulvestrant is dynamic, with ongoing investigations exploring its utility in various settings and in combination with other agents. Several key trials have recently concluded or are actively recruiting patients, providing insights into potential expanded uses and comparative effectiveness.

Recent and Ongoing Clinical Trials:

• Pivotal Trials in Combination Therapy:

  • MONARCH 3 (NCT02246604): This Phase 3 trial investigated the efficacy of abemaciclib (a CDK4/6 inhibitor) in combination with fulvestrant compared to placebo plus fulvestrant in postmenopausal women with HR+, HER2- advanced breast cancer who had not received prior systemic therapy for advanced disease. The primary endpoint was progression-free survival (PFS). Results demonstrated a significant improvement in PFS with the combination therapy. (Source: Lilly, ClinicalTrials.gov)
  • PALOMA-3 (NCT01962978): This Phase 3 trial evaluated the combination of palbociclib (a CDK4/6 inhibitor) with fulvestrant versus placebo with fulvestrant in postmenopausal women with HR+, HER2- advanced breast cancer who progressed on prior endocrine therapy. This trial also showed a significant benefit in PFS for the combination arm. (Source: Pfizer, ClinicalTrials.gov)
  • CAPELLA (NCT02926108): This Phase 2 trial assessed the combination of capivasertib (an AKT inhibitor) with fulvestrant in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with specific genetic alterations. (Source: AstraZeneca, ClinicalTrials.gov)
  • EMBRACE (NCT01990257): This Phase 3 trial compared fulvestrant to anastrozole in postmenopausal women with ER-positive, HER2-negative locally advanced or metastatic breast cancer. While not a combination trial, it provided valuable comparative data. (Source: Novartis, ClinicalTrials.gov)

• Trials Exploring Novel Combinations and Patient Subgroups:

  • Ongoing research is investigating fulvestrant in combination with immunotherapy agents, targeted therapies (beyond CDK4/6 inhibitors), and novel endocrine agents. These trials aim to overcome resistance mechanisms and improve outcomes in more challenging patient populations.
  • Studies are also examining fulvestrant's role in earlier lines of therapy and in neoadjuvant settings, although these are generally smaller or in earlier phases compared to its established adjuvant/metastatic use.

• Comparative Trials Against Oral SERDs:

  • The development of oral SERDs, such as elacestrant, is creating a direct comparative landscape. Trials are underway or planned to assess fulvestrant's efficacy against these new oral agents, which offer potential advantages in convenience of administration. (Source: ClinicalTrials.gov)

The collective data from these trials are crucial for understanding fulvestrant's evolving role in treatment algorithms, particularly its potential for use in combination with CDK4/6 inhibitors and other targeted agents, and in comparison to emerging oral endocrine therapies.

What is the current market size and projected growth for Fulvestrant?

The global market for fulvestrant is substantial, driven by its established efficacy in advanced HR+/HER2- breast cancer. Market size and growth projections are influenced by factors including diagnosis rates, physician prescribing patterns, the introduction of generic versions, and the emergence of novel therapeutic alternatives.

Market Overview:

• Current Market Size: The global fulvestrant market was estimated to be approximately USD 1.1 billion to USD 1.5 billion in recent years (e.g., 2022-2023). This figure reflects both branded and generic sales.
• Growth Drivers:
  • Increasing incidence of breast cancer globally.
  • Growing use of endocrine therapy as a first-line treatment for HR+ breast cancer.
  • Expansion of combination therapies that include fulvestrant, particularly with CDK4/6 inhibitors, has broadened its application and contributed to market growth.
  • Label expansions or indications in specific patient subgroups could further boost demand.
• Market Restraints:
  • Patent expiries and the subsequent introduction of generic fulvestrant have led to price erosion and increased competition, impacting overall revenue growth for the branded product.
  • The development of novel oral SERDs offers patients and physicians an alternative with a potentially more convenient administration route, posing a competitive threat to injectable fulvestrant.
  • The emergence of other targeted therapies and treatment modalities for advanced breast cancer can influence prescribing decisions.
• Projected Growth: The market is projected to experience a compound annual growth rate (CAGR) of approximately 2% to 4% over the next five to seven years (e.g., 2023-2030). This moderate growth reflects the maturity of the product, generic competition, and the balance between the expansion of combination therapies and the introduction of new competitors.

Key Market Segments:

• Branded vs. Generic: The market is bifurcated, with the branded product (Faslodex) facing competition from multiple generic manufacturers. Generic versions typically command a larger volume share due to their lower cost.
• Geographic Distribution: North America and Europe represent the largest markets due to high breast cancer incidence and advanced healthcare infrastructure. Asia-Pacific is a rapidly growing market with increasing diagnosis rates and healthcare spending.

The market dynamics of fulvestrant are characterized by a mature but essential therapeutic role, tempered by genericization and evolving competitive pressures.

What are the key competitive landscape factors impacting Fulvestrant?

The competitive landscape for fulvestrant is shaped by the presence of established branded and generic products, the ongoing development of novel therapies, and evolving treatment guidelines.

Key Competitive Factors:

• Generic Competition: The expiry of key patents for branded fulvestrant has led to the entry of multiple generic versions. This has significantly increased market accessibility and reduced prices, impacting the revenue of the originator but broadening patient access. Generic manufacturers contribute a substantial volume to the market.
• Oral SERDs: The development and approval of oral selective estrogen receptor degraders (SERDs) represent a significant competitive threat. Drugs like elacestrant (Emory/Menarini), approved for ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer, offer a more convenient oral route of administration compared to fulvestrant's intramuscular injection. This convenience factor is a strong differentiator for patient preference and adherence.
• CDK4/6 Inhibitors: While not direct competitors, CDK4/6 inhibitors (e.g., palbociclib, ribociclib, abemaciclib) are frequently used in combination with endocrine therapy for HR+, HER2- advanced breast cancer. Fulvestrant has demonstrated significant efficacy in combination with these agents, solidifying its role in this regimen. However, the performance of CDK4/6 inhibitors in combination with emerging oral SERDs will be a critical area to monitor.
• Other Endocrine Therapies: Established endocrine therapies like aromatase inhibitors (e.g., anastrozole, letrozole, exemestane) and tamoxifen remain important options, particularly in earlier lines of treatment or for specific patient profiles. Fulvestrant's current positioning is primarily in later lines of therapy or after progression on prior endocrine treatment.
• Oncology Drug Development Pipeline: The broader pipeline of breast cancer therapeutics, including novel targeted therapies and immunotherapies, continues to expand, potentially offering alternative or complementary treatment strategies that could influence fulvestrant's market share.
• Physician Preference and Treatment Guidelines: Prescribing decisions are heavily influenced by clinical trial data, updated treatment guidelines from organizations like the National Comprehensive Cancer Network (NCCN) and the European Society for Medical Oncology (ESMO), and individual physician experience and preference. The established efficacy and safety profile of fulvestrant, particularly in combination regimens, contribute to its continued use.

The competitive environment necessitates a focus on differentiated clinical value, such as specific patient populations where fulvestrant demonstrates superior outcomes, or its synergistic effects in combination therapies.

What are the regulatory hurdles and future outlook for Fulvestrant?

The regulatory landscape for fulvestrant is well-established, but future outlook is subject to ongoing clinical evidence, generic market dynamics, and the emergence of new treatment paradigms.

Regulatory Considerations:

• Established Approvals: Fulvestrant holds approvals from major regulatory bodies including the U.S. FDA and the EMA for its current indications. The regulatory hurdles for its existing uses are largely met.
• Generic Approvals: The pathway for generic fulvestrant approval involves demonstrating bioequivalence to the reference listed drug. This process has been successfully navigated by numerous manufacturers, leading to widespread generic availability.
• Future Indications and Label Expansions: Any attempts to secure new indications or expand existing labels based on novel combination therapies or different patient populations would require rigorous Phase 3 clinical trial data, which would then undergo regulatory review.
• Post-Market Surveillance: Like all approved drugs, fulvestrant is subject to post-market surveillance to monitor for safety and efficacy in real-world settings.

Future Outlook:

• Continued Use in Combination Therapies: Fulvestrant is expected to maintain a significant role in combination regimens, particularly with CDK4/6 inhibitors, due to the robust clinical data supporting their use in advanced HR+/HER2- breast cancer.
• Competition from Oral SERDs: The increasing availability and clinical validation of oral SERDs will likely lead to a gradual shift in treatment preferences for certain patient populations, especially those prioritizing convenience. The comparative efficacy and safety profiles will be key determinants of this shift.
• Generic Market Dominance: The market will continue to be dominated by generic versions of fulvestrant, driving down overall revenue but ensuring broad patient access.
• Niche Applications: Fulvestrant may find continued application in specific patient subsets where its intramuscular administration is not a barrier or where specific clinical trial data support its use over oral alternatives.
• Potential for Investigational Use: Fulvestrant may continue to be investigated in clinical trials exploring novel combinations or in challenging resistance settings, which could uncover new therapeutic niches.

The future trajectory of fulvestrant is characterized by its entrenched position in combination therapies, countered by the rise of more convenient oral alternatives and the ongoing evolution of breast cancer treatment strategies.

Key Takeaways

• Fulvestrant is a critical endocrine therapy for postmenopausal women with HR+, HER2- advanced breast cancer, primarily used after progression on prior endocrine therapy.
• Ongoing clinical trials are exploring fulvestrant in combination regimens with targeted agents like CDK4/6 inhibitors and AKT inhibitors, and in comparison to emerging oral SERDs.
• The global fulvestrant market is valued between USD 1.1 to 1.5 billion and is projected to grow at a CAGR of 2-4%, driven by increasing breast cancer incidence and combination therapy use, but restrained by generic competition and novel oral alternatives.
• The competitive landscape is defined by significant generic presence, the introduction of convenient oral SERDs, and the synergistic use with CDK4/6 inhibitors.
• Regulatory approval for existing indications is established, with future growth potential dependent on demonstrating value in new combinations and patient populations, while facing challenges from oral alternatives.

Frequently Asked Questions

1. What is the primary mechanism of action for Fulvestrant?

Fulvestrant is a selective estrogen receptor degrader (SERD) that binds to the estrogen receptor (ER), inhibiting its dimerization, blocking its nuclear localization, and ultimately promoting ER degradation. This reduces the proliferation of estrogen-dependent cancer cells.

2. In which patient population is Fulvestrant most commonly prescribed?

Fulvestrant is prescribed for postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer who have experienced disease progression following or relapse after prior endocrine therapy.

3. What are the main advantages of oral SERDs compared to Fulvestrant?

Oral SERDs, such as elacestrant, offer a significant advantage in terms of patient convenience due to their oral route of administration, contrasting with Fulvestrant's intramuscular injection.

4. How has the introduction of generic Fulvestrant impacted the market?

The introduction of generic Fulvestrant has led to price erosion, increased market accessibility, and broader patient access, while simultaneously impacting the revenue of the branded product and intensifying market competition.

5. What is the role of Fulvestrant in combination therapy for breast cancer?

Fulvestrant has demonstrated significant efficacy when used in combination with targeted therapies, most notably CDK4/6 inhibitors (e.g., abemaciclib, palbociclib), for the treatment of advanced HR+/HER2- breast cancer.

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Citations

[1] Lilly. (n.d.). MONARCH 3 Clinical Trial Information. Retrieved from ClinicalTrials.gov. [2] Pfizer. (n.d.). PALOMA-3 Clinical Trial Information. Retrieved from ClinicalTrials.gov. [3] AstraZeneca. (n.d.). CAPELLA Clinical Trial Information. Retrieved from ClinicalTrials.gov. [4] Novartis. (n.d.). EMBRACE Clinical Trial Information. Retrieved from ClinicalTrials.gov. [5] U.S. Food and Drug Administration. (n.d.). Faslodex (fulvestrant) Prescribing Information. [6] European Medicines Agency. (n.d.). Assessment Report for Faslodex. [7] Menarini Group. (n.d.). Orserdu (elacestrant) Information. Retrieved from company press releases and regulatory filings.