Clinical trials: Fulvestrant
Inguinal Hernia Unilateral, Inguinal Hernia Bilateral
Reversing InGuinal Hernia Trial: The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males
This is a prospective, single-center, two-arm Phase 1 safety and feasibility trial evaluating anti-estrogen therapy in men age 50 years and older with symptomatic unilateral inguinal hernias.
- Conditions
- Inguinal Hernia Unilateral, Inguinal Hernia Bilateral, Inguinal Hernia Without Obstruction or Gangrene, Inguinal Hernia, Without Mention of Obstruction or Gangrene
- Trial name
- RIGHT (NCT07604272)
- Testing
- Fulvestrant, Anastrozole (ARIMIDEX™)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Northwestern University
Breast Neoplasms, Solid Tumors
A Phase 1/2a Study of K-1728 in Advanced Solid Tumors
This first-in-human, open-label, multicenter study evaluates K-1728 administered as monotherapy and in combination in participants with advanced or metastatic solid tumors.
- Conditions
- Breast Neoplasms, Solid Tumors, PIK3CA Gene Mutation
- Trial name
- PIKYMA-01 (NCT07861932)
- Testing
- K-1728, Fulvestrant, Palbociclib
- Volunteers
- 110 people
- Sponsor
- KymaThera, Inc.
Advanced or Metastatic ER+ HER2- Breast Cancer (mBC), Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors
This is a first-in-human, open-label, multicenter phase 1 study to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A/B)…
- Conditions
- Advanced or Metastatic ER+ HER2- Breast Cancer (mBC), Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC), Advanced or Metastatic Castration-Resistant Prostate Cancer (mCRPC), Metastatic Breast Cancer
- Trial name
- NCT06784193
- Testing
- OP-3136, Fulvestrant, Palazestrant
- Where
- 25 sites in United States, Australia and 4 more
- Volunteers
- 180 people
- Sponsor
- Olema Pharmaceuticals, Inc.
PIK3CA Mutation, HER2- Negative Breast Cancer
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with…
- Conditions
- PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer
- Trial name
- ReDiscover-2 (NCT06982521)
- Testing
- Zovegalisib, Capivasertib, Fulvestrant
- Where
- 243 sites in United States, Argentina and 25 more
- Volunteers
- 540 people
- Sponsor
- Relay Therapeutics, Inc.
Locally Advanced Breast Cancer, Metastatic Breast Cancer
A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer
This study is a multicenter, open-label, randomized controlled Phase 3 clinical trial. It is planned to enroll 240 female patients with locally advanced or metastatic breast cancer followed by disease progression after previous…
- Trial name
- NCT07024173
- Testing
- HRS-8080 Tablet, Fulvestrant injection, Exemestane tablets
- Where
- 2 sites in China
- Volunteers
- 240 people
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Solid Tumor, Adult, Metastatic Breast Cancer
Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
First in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.
- Conditions
- Solid Tumor, Adult, Metastatic Breast Cancer, Advanced Breast Cancer, HER2 Mutation-Related Tumors
- Trial name
- NCT06625775
- Testing
- BBO-10203, Trastuzumab, Fulvestrant
- Where
- 44 sites in United States, Australia and 4 more
- Volunteers
- 392 people
- Sponsor
- TheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
Breast Cancer
Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.
The purpose of this study is to complement Study CBYL719C2301 (SOLAR-1) and obtain more comprehensive data on the efficacy and safety of alpelisib (BYL719) in combination with fulvestrant compared with placebo plus fulvestrant in…
- Trial name
- EPIK-B5 (NCT05038735)
- Testing
- Alpelisib, Fulvestrant
- Where
- 68 sites in Belgium, Bulgaria and 15 more
- Volunteers
- 210 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Solid Tumor, HR+/HER2- Breast Cancer
Study of AVZO-021 in Patients With Advanced Solid Tumors
This study, the first clinical trial of AVZO-021, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and anti-tumor effects of AVZO-021 in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor, HR+/HER2- Breast Cancer, HR+, HER2-, Advanced Breast Cancer, CCNE1 Amplification
- Trial name
- NCT05867251
- Testing
- AVZO-021, Palbociclib, Fulvestrant
- Where
- 13 sites in United States, Australia
- Volunteers
- 430 people
- Sponsor
- Avenzo Therapeutics, Inc.
Metastatic Breast Cancer
A Study of Lenvatinib, Pembrolizumab, and Fulvestrant in People With Breast Cancer
The purpose of this study is to test whether the combination of lenvatinib, pembrolizumab, and fulvestrant is a safe and effective treatment that causes few or mild side effects in people with ER+/HER2- metastatic breast cancer.
- Trial name
- NCT06110793
- Testing
- Lenvatinib, Pembrolizuma, Fulvestrant
- Where
- 7 sites in United States
- Volunteers
- 56 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Advanced Solid Tumor
A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity of BG-75098 alone and in combination with BGB-43395 and fulvestrant in participants with…
- Trial name
- NCT07226349
- Testing
- BG-75098, BGB-43395, Fulvestrant
- Where
- 23 sites in United States, Australia and 2 more
- Volunteers
- 105 people
- Sponsor
- BeOne Medicines
Adenocarcinoma of Endometrium
Evaluating Cancer Response to Treatment With Abemaciclib and Fulvestrant in Women With Recurrent Endometrial Cancer
The purpose of this study is to determine the effectiveness of the combination of abemaciclib and fulvestrant in treating this type of cancer and to determine the types and severity of side effects caused by treatment with…
- Trial name
- NCT03643510
- Testing
- Fulvestrant, Abemaciclib
- Where
- 7 sites in United States
- Volunteers
- 27 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Advanced Breast Cancer, HR+/HER2- Breast Cancer
Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer
This is a randomized, controlled, open-label, phase III study to explore the efficacy and safety of Apatinib in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF4 subtype of advanced breast cancer.
- Trial name
- NCT06447623
- Testing
- Apatinib, CDK4/6 Inhibitor, Aromatase inhibitor and Fulvestrant
- Where
- China
- Volunteers
- 184 people
- Sponsor
- Fudan University
Estrogen Receptor Status, HER2/Neu Negative
Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer
This phase II trial studies how well alisertib with or without fulvestrant works in treating patients with endocrine-resistant breast cancer that has spread to other places in the body.
- Conditions
- Estrogen Receptor Status, HER2/Neu Negative, Invasive Breast Carcinoma, Postmenopausal
- Trial name
- NCT02860000
- Testing
- Alisertib, Fulvestrant, Laboratory Biomarker Analysis
- Where
- 8 sites in United States
- Volunteers
- 96 people
- Sponsor
- Mayo Clinic
HER2+/HR+ Breast Cancer
Phase 2a Study of ZW25 in Combination With Palbociclib Plus Fulvestrant
This is a multicenter, Phase 2a, open-label, 2-part study to investigate the safety, tolerability, and anti-tumor activity of ZW25 (zanidatamab) in combination with palbociclib plus fulvestrant.
- Trial name
- NCT04224272
- Testing
- ZW25 (Zanidatamab), Palbociclib, Fulvestrant
- Where
- 13 sites in United States, Canada and 1 more
- Volunteers
- 51 people
- Sponsor
- Jazz Pharmaceuticals
Breast Cancer
Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer
The primary objective of Phase 1b will be to evaluate the safety and tolerability of TTI-101 when added to palbociclib and AI or fulvestrant administered orally to participants with hormone receptor-positive (HR+) human epidermal…
- Trial name
- NCT05384119
- Testing
- TTI-101, Palbociclib, Aromatase inhibitor (AI)
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Tvardi Therapeutics, Incorporated
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer
This phase II trial tests the accuracy of functional imaging (FFNP)-positron emission tomography (PET)/computed tomography (CT) to predict response to abemaciclib plus endocrine therapy.
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Unresectable HER2-Negative Breast Carcinoma, Locally Advanced Unresectable Hormone Receptor-Positive Breast Carcinoma
- Trial name
- NCT06179303
- Testing
- Abemaciclib, Anastrozole, Biospecimen Collection
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- University of Washington
Advanced Breast Cancer
Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer
The purpose of this study is to assess the safety and efficacy of alpelisib plus fulvestrant in men and postmenopausal women with hormone receptor (HR) positive, human epidermal growth factor 2 (HER2)-negative, advanced breast…
- Trial name
- NCT04524000
- Testing
- Alpelisib, Fulvestrant
- Where
- 15 sites in Japan
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Breast Neoplasms
Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer
The primary objective is to evaluate whether treatment with alpelisib in combination with fulvestrant prolongs Progression Free Survival (PFS) compared to treatment with placebo in combination with fulvestrant.
- Trial name
- NCT04544189
- Testing
- Alpelisib, Fulvestrant
- Where
- 24 sites in China
- Volunteers
- 69 people
- Sponsor
- Novartis Pharmaceuticals
PIK3CA-Related Overgrowth Spectrum (PROS), Breast Neoplasms (Including Advanced or Metastatic Breast Cancer With PIK3CA Mutation)
Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety.
The purpose of this study is to provide post-trial access to alpelisib and to assess its long-term safety when administered as a single agent or in combination with other drugs.
- Trial name
- EPIK-RO (NCT07679269)
- Testing
- Alpelisib, Fulvestrant, Trastuzumab
- Volunteers
- 51 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer Metastatic
Apatinib With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2- Advanced Breast Cancer
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
- Trial name
- NCT05759572
- Testing
- Apatinib, Dalpiciclib, Fulvestrant/AI
- Where
- China
- Volunteers
- 145 people
- Sponsor
- Fudan University