Clinical trials: ER Positive
Breast Cancer
A Companion Sample Collection Protocol to Support the Discovery of Breast Cancer Aberrations With Treatment of CDK4/6 Therapy/LEE011/Ribociclib
This study was a companion study to CLEE011A2404 which provided the opportunity for the collection of tumor tissue samples to better understand relevant mutations and the mechanisms responsible for resistance to treatment.
- Trial name
- NCT03050398
- Testing
- Ribociclib, letrozole
- Where
- 6 sites in United States
- Volunteers
- 8 people
- Sponsor
- Novartis Pharmaceuticals
Breast Neoplasms, Invasive Breast Cancer
(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer
This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer.
- Conditions
- Breast Neoplasms, Invasive Breast Cancer, Estrogen-receptor-positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- EVANGELINE (NCT05607004)
- Testing
- (Z)-endoxifen, goserelin
- Where
- 14 sites in United States
- Volunteers
- 87 people
- Sponsor
- Atossa Therapeutics, Inc.
Advanced Estrogen Receptor Positive HER2- Breast Cancer
GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer
The primary objectives of the Phase 1b Dose Escalation part of this study are to characterize the safety and tolerability of GS-5829 in combination with exemestane or fulvestrant and to determine the maximum tolerated dose (MTD)…
- Trial name
- NCT02983604
- Testing
- GS-5829, Exemestane, Fulvestrant
- Where
- 6 sites in United States
- Volunteers
- 14 people
- Sponsor
- Gilead Sciences
ER+ HER2- Advanced Breast Cancer
Study of AZD9833 Alone or in Combination in Women With Advanced Breast Cancer.
A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Women with ER Positive, HER2 Negative Advanced Breast Cancer (SERENA-1)
- Trial name
- SERENA-1 (NCT03616587)
- Testing
- AZD9833, AZD9833 with palbociclib, AZD9833 with everolimus
- Where
- 17 sites in United States, Spain and 1 more
- Volunteers
- 396 people
- Sponsor
- AstraZeneca
Advanced Solid Tumors With an Alteration of the PIK3CA Gene, Estrogen Receptor Positive Breast Cancer
A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene
This is a first-in-man trial, in which BYL719 will be administered to adult patients with advanced solid tumors, whose tumors have an alteration of the PIK3CA gene and whose disease has progressed despite standard therapy or for…
- Trial name
- NCT01219699
- Testing
- BYL719, Fulvestrant
- Where
- 11 sites in United States, Germany and 3 more
- Volunteers
- 221 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study of LY3484356 in Women With Breast Cancer Before Having Surgery
The purpose for this study is to see if the study drug, LY3484356, is safe and to determine what effects it has on breast cancer in participants with Estrogen Receptor Positive (ER+), HER2 Negative (HER2-) early stage (stage…
- Trial name
- EMBER-2 (NCT04647487)
- Testing
- LY3484356
- Where
- 19 sites in United States, Belgium and 4 more
- Volunteers
- 87 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer
This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or RP2D, evaluate the PK properties and evaluate…
- Trial name
- NCT03471663
- Testing
- D-0502, palbociclib
- Where
- 15 sites in United States, China
- Volunteers
- 200 people
- Sponsor
- InventisBio Co., Ltd
Metastatic Breast Cancer
A Study of JNJ-101684362 (HLD-0117) in Patients With Metastatic Breast Cancer
The purpose of this study is to find out the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDEs) of JNJ-101684362 (HLD-0117), to evaluate the safety of JNJ-101684362 (HLD-0117) , and how well the…
- Trial name
- HLD-0117 (NCT07524855)
- Testing
- JNJ-101684362 (HLD-0117)
- Where
- 6 sites in United States
- Volunteers
- 170 people
- Sponsor
- Janssen Research & Development, LLC
Breast Cancer
Study to Determine Treatment Effects of Denosumab in Patients With Breast Cancer Receiving Aromatase Inhibitor Therapy
The purpose of this study is to determine whether denosumab compared to placebo, will reduce the rate of first clinical fracture in women with non-metastatic breast cancer receiving (non-steroidal) aromatase inhibitor therapy.
- Trial name
- NCT00556374
- Testing
- Denosumab, Non-steroidal aromatase inhibitor therapy, Zoledronic Acid
- Where
- 46 sites in Austria, Sweden
- Volunteers
- 3,420 people
- Sponsor
- Amgen
Breast Neoplasms
Sapanisertib in Combination With Fulvestrant in Women With Advanced or Metastatic Breast Cancer After Aromatase Inhibitor Therapy
The primary purpose of this study is to compare the progression free survival (PFS) of participants treated with the combination of fulvestrant plus daily sapanisertib and fulvestrant plus weekly sapanisertib versus participants…
- Trial name
- NCT02756364
- Testing
- Fulvestrant, Sapanisertib
- Where
- 53 sites in United States, Spain
- Volunteers
- 141 people
- Sponsor
- Calithera Biosciences, Inc
Breast Neoplasms, Brain Neoplasms
Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth…
- Conditions
- Breast Neoplasms, Brain Neoplasms, Neoplasms by Site, Neoplasms
- Trial name
- ELECTRA (NCT05386108)
- Testing
- Elacestrant, Abemaciclib
- Where
- 86 sites in United States, Belgium and 8 more
- Volunteers
- 73 people
- Sponsor
- Stemline Therapeutics, Inc.
Unresectable or Metastatic Breast Cancer
Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer
This is a multicenter, open phase Ib/II clinical study, which is divided into two phases: dose exploration and efficacy expansion.
- Trial name
- NCT06167694
- Testing
- HRS-8080; Dalpiciclib Isethionate Tablets
- Where
- 2 sites in China
- Volunteers
- 146 people
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Breast Cancer
A Phase II Study of Everolimus in Combination With Exemestane Versus Everolimus Alone Versus Capecitabine in Advance Breast Cancer.
This was a three-arm, randomized, open label, multi-center phase II study investigating the combination of everolimus (10mg daily) with exemestane (25mg daily) versus everolimus (10mg daily) versus capecitabine (1250mg/m2 twice…
- Trial name
- BOLERO-6 (NCT01783444)
- Testing
- Capecitabine, Exemestane, Everolimus
- Where
- 83 sites in United States, Argentina and 16 more
- Volunteers
- 309 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer
This study is a multi-center, open-label, Phase 1 clinical study to evaluate the safety, pharmacokinetic (PK) and anti-tumor efficacy of SIM0270 and SIM0270 in combination with palbociclib or everolimus in subjects with estrogen…
- Trial name
- NCT05293964
- Testing
- SIM0270, Palbociclib, everolimus
- Where
- China
- Volunteers
- 214 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Metastatic Breast Cancer
ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study
The purpose of this study is to evaluate the efficacy and safety of elacestrant over the course of 6 months in patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor-2 negative (HER2-)…
- Trial name
- ELCIN (NCT05596409)
- Testing
- Elacestrant
- Where
- 22 sites in United States, Brazil and 4 more
- Volunteers
- 61 people
- Sponsor
- Stemline Therapeutics, Inc.
Her2 Negative Breast Cancer Patients
Trial of Exemestane +/- MM-121 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive and/or Progesterone Receptor Positive Her2 Negative Breast Cancer
To determine whether the combination MM-121 + Exemestane in ER+ and/or PR+ breast cancer patients is more effective than Exemestane alone
- Trial name
- NCT01151046
- Testing
- MM-121, Exemestane
- Where
- 33 sites in United States, Canada and 3 more
- Volunteers
- 118 people
- Sponsor
- Merrimack Pharmaceuticals
Post Menopausal Breast Cancer
Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
This international, multi-center, open-label, single-arm study evaluated the safety and tolerability profile of everolimus in post-menopausal women with HR positive, HER2 negative locally advanced or metastatic breast cancer…
- Trial name
- EVEREXES (NCT03176238)
- Testing
- everolimus, exemestane
- Where
- 55 sites in Australia, India and 11 more
- Volunteers
- 235 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
HS-10352 is a highly potent and selective small molecule inhibitor of phosphoinositide 3-kinase (p110α). In preclinical studies, it demonstrated strong activity against PI3K p110α in vitro and in vivo, and inhibited tumor cell…
- Trial name
- NCT04631835
- Testing
- HS-10352
- Where
- 3 sites in China
- Volunteers
- 54 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Postmenopausal Women With ER+ HER2- Primary Breast Cancer
Study to Compare the Effects of AZD9496 vs Fulvestrant in Breast Cancer.
This is an open label randomised multicentre pre-surgical pharmacodynamics study to compare and assess the biological effects of AZD9496 and fulvestrant in postmenopausal women with estrogen receptor (ER) positive (ER+), human…
- Trial name
- D6090C00002 (NCT03236974)
- Testing
- Standard Arm - Fulvestrant, AZD9496
- Where
- 12 sites in Germany, United Kingdom
- Volunteers
- 49 people
- Sponsor
- AstraZeneca
Metastatic ER+ Her2- Breast Cancer, Postmenopausal
A Study of Abiraterone Acetate Plus Prednisone With or Without Exemestane in Postmenopausal Women With Estrogen Receptor-Positive (ER+) Metastatic Breast Cancer Progressing After Letrozole or Anastrozole Therapy
The purpose of this study is to assess the safety and efficacy of oral abiraterone acetate plus oral prednisone and oral abiraterone acetate plus oral prednisone plus oral exemestane, each compared with oral exemestane alone, in…
- Trial name
- NCT01381874
- Testing
- Exemestane, Abiraterone acetate + Prednisone/ Prednisolone + Exemestane, Abiraterone acetate + Prednisone or Prednisolone
- Where
- 81 sites in United States, Belgium and 10 more
- Volunteers
- 297 people
- Sponsor
- Janssen Research & Development, LLC