Clinical trials: Fulvestrant
Metastatic HR+/HER2- Breast Cancer
Rash & Diarrhea Prophylaxis With Capivasertib
This is a randomized, multicenter, phase II clinical trial evaluating prophylactic strategies to mitigate common toxicities associated with capivasertib in combination with fulvestrant in participants with hormone…
- Trial name
- SAFE-CAP (NCT07426822)
- Testing
- Capivasertib, Loperamide, Fulvestrant
- Where
- United States
- Volunteers
- 108 people, healthy volunteers welcome
- Sponsor
- Maryam Lustberg
Neoplasm, Breast, Congenital, Familial and Genetic Disorders
SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast)
The study is a nationwide, multicenter single-arm phase 2 study. The current phase 2 study investigates the efficacy of the combination of fulvestrant and alpelisib directly after progression on fulvestrant (either in first or…
- Trial name
- SEQUEL-Breast (NCT05392608)
- Testing
- Alpelisib 150 MG Oral Tablet [Piqray], Fulvestrant
- Where
- 25 sites in Netherlands
- Volunteers
- 130 people, healthy volunteers welcome
- Sponsor
- Borstkanker Onderzoek Groep
Healthy Postmenopausal Women
Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of KSHN001034 in Healthy Postmenopausal Female Volunteers
The goal of this clinical trial is to evaluate if KSHN001034 demonstrates safety, tolerability, and a comparable pharmacokinetic (PK) profile to the reference product, Faslodex® (fulvestrant), which is used for the treatment of…
- Trial name
- NCT06995482
- Testing
- KSHN001034, Fulvestrant
- Where
- 2 sites in United States, India
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Kashiv BioSciences, LLC
Postmenopausal Women
A Study of Single Dose of BL0175 in Postmenopausal Women
The goal of this clinical trial is to learn the safety and PK of the single dose of BL0175 Injection in postmenopausal women and to compare that with a single dose of Fulvestrant Injection.
- Trial name
- NCT07366632
- Testing
- BL0175, Fulvestrant
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Shanghai Best-Link Bioscience, LLC
Breast Cancer
A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer.
This study is a randomised, open-label, multicentre phase III clinical study evaluating the efficacy and safety of JS105 combined with Dalpiciclib and Fulvestrant compared with Dalpiciclib and Fulvestrant in patients with…
- Trial name
- NCT07207070
- Testing
- JS105, Dalpiciclib, Fulvestrant 50 Mg/mL Intramuscular Solution
- Where
- 2 sites in China
- Volunteers
- 312 people, healthy volunteers welcome
- Sponsor
- Risen (Suzhou) Pharma Tech Co., Ltd.
Metastatic Breast Cancer
Open Label, Sequential Dosing , Single Ascending Dose and Multiple Dose Safety Tolerability and Pharmacokinetic Study
The goal of this clinical trial is to learn the comparative pharmacokinetic parameters between the test product and the Reference listed drug in healthy female volunteers The main question[s] it aims to answer are: To assess the…
- Trial name
- NCT06074757
- Testing
- Fulvestrant injection
- Where
- Jordan
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Kashiv BioSciences, LLC
Pharmacokinetics
Study to Evaluate the Safety, Tolerability, and PK of Fulvestrant After IM Administration
Clinical study designed to assess the plasma pharmacokinetic profile and tolerability of Fulvestrant for Injectable Suspension after a single IM dose of Fulvestrant for Injectable Suspension compared to the reference product…
- Trial name
- NCT03324061
- Testing
- Fulvestrant for Injectable Suspension, Faslodex (Reference)
- Where
- 12 sites in United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Eagle Pharmaceuticals, Inc.
Metastatic Breast Cancer
Pyrotinib in Combination With Fulvestrant in Patients With HER2 Positive，HR-Positive Metastatic Breast Cancer
HR+/HER2+（Human epidermal growth factor receptor 2 positive and hormone receptor positive）metastatic breast cancer is a special subtype of HER2+breast cancer.
- Trial name
- NCT04034589
- Testing
- Pyrotinib combined with fulvestrant
- Where
- 2 sites in China
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Healthy
Bioequivalence Study of Fulvestrant Injection 50 mg/mL in Healthy Post-menopausal Female Subjects
The purpose of this study is to demonstrate bioequivalence between the test drug product, fulvestrant Injection, 50 mg/mL, and the Reference Listed Drug, Faslodex® Injection, 50 mg/mL.
- Trial name
- NCT02795039
- Testing
- Fulvestrant
- Where
- 3 sites in Canada
- Volunteers
- 266 people, healthy volunteers welcome
- Sponsor
- Fresenius Kabi
Normal Healthy Volunteers
Impact of Endogenous E2 on SSI and GH Rebound
Endogenous estrogens maintain growth hormone (GH) secretion in postmenopausal women by potentiating endogenous GH-releasing hormone (GHRH) drive and restraining somatostatin inhibition of GH release.
- Trial name
- NCT02026973
- Testing
- Fulvestrant, Anastrozole, Somatostatin
- Where
- United States
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Healthy
Role of Endogenous Estrogen in Growth-Hormone Regulation in Postmenopausal Women
Participants are being asked to take part in this research study to learn why growth hormone(GH) levels decline when estrogen production falls at the time of menopause.
- Trial name
- NCT01186796
- Testing
- Fulvestrant
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Systemic Lupus Erythematosus
Efficacy of Faslodex in Treatment of SLE Clinical, Serologic, and Molecular Studies
SLE(Systemic Lupus Erythematosus) is an autoimmune disese that primarily occurs in women(9:1 compared to men). The disease is activated by genetic and environmental factors, yet the female gender is the strongest risk factor.
- Trial name
- NCT00417430
- Testing
- ICI 182,780 (Faslodex)
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- The Center for Rheumatic Disease, Allergy, & Immunology