Drugs / Fulvestrant
Fulvestrant
DrugFulvestrant is an antiestrogen medication and selective estrogen receptor degrader (SERD) used for hormone receptor-positive advanced or metastatic breast cancer. It is administered by intramuscular injection and is marketed under the brand name Faslodex. Fulvestrant was approved for medical use in the United States in 2002.
- Trials
- 477
- Recruiting
- 82
- Completed
- 164
- With results
- 147
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | Active | Completed | Terminated | Withdrawn | Unknown | Total |
|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | — | — | — | 1 | — | 1 | — | 2 |
| Phase 1 | 17 | 5 | 10 | 36 | 12 | 4 | 4 | 88 |
| Phase 1/2 | 19 | 3 | 5 | 7 | 4 | 8 | 7 | 53 |
| Phase 2 | 29 | 11 | 29 | 83 | 37 | 4 | 26 | 219 |
| Phase 2/3 | — | — | 2 | 2 | — | — | 1 | 5 |
| Phase 3 | 13 | 4 | 24 | 21 | 8 | — | 8 | 78 |
| Phase 4 | 1 | — | 1 | 4 | 2 | — | 1 | 9 |
| Not applicable | 2 | — | — | — | — | — | 2 | 4 |
| Unknown | 1 | — | — | 10 | 1 | — | 7 | 19 |
Trials started per year
Conditions studied, by phase
| Condition | Early Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Breast Neoplasms | 2 | 55 | 36 | 150 | 1 | 67 | 8 | 1 | 14 | 334 |
| Neoplasm Metastasis | — | 7 | 1 | 16 | 1 | 12 | 2 | — | 2 | 41 |
| Neoplasms | — | 6 | 3 | 8 | 1 | 4 | — | — | 3 | 25 |
| Ovarian Neoplasms | 1 | 6 | 5 | 6 | — | — | — | — | — | 18 |
| Carcinoma, Non-Small-Cell Lung | — | 6 | 1 | 6 | — | — | — | — | — | 13 |
| Endometrial Neoplasms | — | 3 | 5 | 4 | — | — | — | — | — | 12 |
| Hereditary Sensory and Autonomic Neuropathies | — | 2 | 3 | 3 | — | 2 | — | — | — | 10 |
| Prostatic Neoplasms | 1 | 3 | 2 | 4 | — | — | — | — | — | 10 |
| Triple Negative Breast Neoplasms | — | 6 | 1 | 1 | — | — | — | — | — | 8 |
| Colorectal Neoplasms | — | 3 | 1 | 2 | — | — | — | — | — | 6 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | AstraZeneca | 36 | 14 |
| 2 | Novartis Pharmaceuticals | 25 | 7 |
| 3 | Fudan University | 17 | 1 |
| 4 | Eli Lilly and Company | 15 | 5 |
| 5 | Pfizer | 14 | 3 |
| 6 | Hoffmann-La Roche | 13 | 4 |
| 7 | National Cancer Institute (NCI) | 10 | 1 |
| 8 | Memorial Sloan Kettering Cancer Center | 7 | 0 |
| 9 | Dana-Farber Cancer Institute | 6 | 0 |
| 10 | MedSIR | 6 | 0 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Fulvestrant | 477 |
| 2 | Letrozole | 94 |
| 3 | Anastrozole | 84 |
| 4 | palbociclib | 84 |
| 5 | exemestane | 67 |
| 6 | abemaciclib | 46 |
| 7 | ribociclib | 44 |
| 8 | Tamoxifen | 37 |
| 9 | Trastuzumab | 32 |
| 10 | Alpelisib | 30 |
Evidence
- Results reported
- 89.6%147 of 164 completed
- Published
- 14.6%24 of 164 completed
- Primary endpoint met
- 58.6%34 of 58 analyses
- Median months to report
- 12
Documents disclosed
Trial profile
- Median enrollment
- 100
- Median duration
- 53months
- Countries
- 69
- Study sites
- 10147
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 4
- Phase 1
- 66
- Phase 1/2
- 72
- Phase 2
- 64
- Phase 2/3
- 35
- Phase 3
- 432
- Phase 4
- 130
- Not applicable
- 71
- Unknown
- 272
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | Boston | United States | 88 |
| 2 | Houston | United States | 85 |
| 3 | Barcelona | Spain | 79 |
| 4 | Madrid | Spain | 78 |
| 5 | New York | United States | 77 |
| 6 | Nashville | United States | 76 |
| 7 | London | United Kingdom | 61 |
| 8 | Los Angeles | United States | 60 |
| 9 | Milan | Italy | 59 |
| 10 | Seoul | South Korea | 58 |
Terminations
- Terminated
- 64
- Withdrawn
- 17
- Stopped for recruitment
- 4.4%21 of 477 trials
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT07570966 Withdrawn | Withdrawn | Business decision | 2031-08-01 |
| NCT05905341 Withdrawn | Withdrawn | This decision was based on business considerations and not due to specific safety reasons or a request from a regulatory authority. | 2028-04-13 |
| NCT04316169 Withdrawn | Withdrawn | Funding and PI leaving institution | 2028-01-31 |
| NCT05191004 Withdrawn | Withdrawn | Sponsor decision | 2026-09-30 |
| NCT07408089 Terminated | Terminated | The study was terminated primarily due to a business decision related to a corporate transaction and was not driven by any safety signal. | 2026-07-28 |
| NCT05238831 Withdrawn | Withdrawn | Withdrawn due to a change in therapeutic interventions. | 2026-05-31 |
| NCT05207709 Terminated | Terminated | The study was prematurely halted because enrollment was significantly delayed compared with the original projections due to the evolving therapeutic landscape. | 2026-03-26 |
| NCT05082025 Terminated | Terminated | Copanlisib development was discontinued by Bayer following withdrawal of copanlisib in relapsed follicular lymphoma in November 2023. | 2025-12-12 |
| NCT06408168 Terminated | Terminated | \<75% Participation | 2025-12-08 |
| NCT05252416 Terminated | Terminated | This trial was terminated prior to the initiation of Phase 2 for reasons not due to safety concerns. | 2025-07-04 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: