Clinical trials: Advanced ER+, HER2-Negative Breast Cancer
ER-Positive, HER2-Negative Breast Cancer
A Phase 1 Study of HRS8807 Monotherapy and in Combination With SHR6390 in Subjects With ER-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer
The study is to assess safety and tolerability of HRS8807 monotherapy and in combination with SHR6390 in subjects with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum…
- Trial name
- NCT04993430
- Testing
- HRS8807, HRS8807、SHR6390
- Where
- China
- Volunteers
- 46 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Advanced Solid Tumors, HR+ Breast Cancer
(VELA) Study of BLU-222 in Advanced Solid Tumors
This is a Phase 1/2, open-label, first-in-human (FIH) study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and anticancer activity of BLU-222, a selective inhibitor of CDK2.
- Conditions
- Advanced Solid Tumors, HR+ Breast Cancer, CCNE1 Amplification, HER2-negative Breast Cancer
- Trial name
- NCT05252416
- Testing
- BLU-222, Carboplatin, Ribociclib
- Where
- 23 sites in United States, Italy and 1 more
- Volunteers
- 50 people
- Sponsor
- Blueprint Medicines Corporation
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 ER+, HER2-Negative Breast Cancer
A Phase I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer
The purpose of this study is to evaluate the safety, tolerability and preliminary efficacy of elacestrant (RAD1901) in patients with advanced ER+, HER2-negative breast cancer.
- Trial name
- NCT02338349
- Testing
- Elacestrant
- Where
- United States
- Volunteers
- 57 people
- Sponsor
- Stemline Therapeutics, Inc.
Breast Cancer
[177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer
The purpose of this trial is to estimate the recommended dose (RD) of [177Lu]Lu-NeoB in combination with ribociclib and fulvestrant in participants with estrogen receptor (ER) positive (ER+), human epidermal growth factor…
- Trial name
- NCT05870579
- Testing
- [68Ga]Ga-NeoB, [177Lu]Lu-NeoB, Ribociclib
- Where
- 13 sites in United States, China and 5 more
- Volunteers
- 28 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer.
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Colorectal Cancer, Metastatic Colorectal Adenocarcinoma
- Trial name
- NCT07318805
- Testing
- PF-08032562, Fulvestrant, Cetuximab
- Where
- 17 sites in United States, France and 1 more
- Volunteers
- 260 people
- Sponsor
- Pfizer
Breast Cancer
A Rollover Protocol of Elacestrant, in Combination With Onapristone, for Patients With ER+, PR+, HER2- Advanced or Metastatic Breast Cancer
This is a rollover study for patients enrolled in the discontinued ELONA clinical trial (ONA-XR-103) with the primary objective to characterize the safety of elacestrant in combination with onapristone either alone or in…
- Trial name
- NCT06938711
- Testing
- Elacestrant, Onapristone
- Where
- United States
- Sponsor
- Context Therapeutics Inc.
Breast Cancer, Locally Advanced Breast Cancer
Palazestrant in Combination With Ribociclib for the First-line Treatment of ER+/HER2- Advanced Breast Cancer
This phase 3 clinical trial compares the efficacy and safety of palazestrant with ribociclib to letrozole and ribociclib in women and men who have not received prior systemic anti-cancer treatment for advanced breast cancer.
- Conditions
- Breast Cancer, Locally Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer
- Trial name
- OPERA-02 (NCT07085767)
- Testing
- Palazestrant, Ribociclib, Letrozole
- Where
- 200 sites in United States, Australia and 21 more
- Volunteers
- 1,000 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Breast Cancer
A Study of GDC-0810 Versus Fulvestrant in Postmenopausal Women With Advanced or Metastatic Breast Cancer Resistant to Aromatase Inhibitor (AI) Therapy
The primary purpose of this study is to evaluate the efficacy, safety, and tolerability of GDC-0810 compared with fulvestrant in postmenopausal women with advanced or metastatic estrogen receptor positive (ER+)/ human epidermal…
- Trial name
- HydranGea (NCT02569801)
- Testing
- Fulvestrant, GDC-0810
- Where
- 44 sites in United States, Australia and 4 more
- Volunteers
- 71 people
- Sponsor
- Genentech, Inc.
HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC)
A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
The goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1…
- Conditions
- HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC), CCNE1 Amplified Advanced Solid Tumors, HR+ HER2- Breast Cancer
- Trial name
- NCT07029399
- Testing
- NKT5097 CDK2/CDK4 dual degrader, Fulvestrant, Letrozole
- Where
- 19 sites in United States
- Volunteers
- 361 people
- Sponsor
- NiKang Therapeutics, Inc.
Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)
This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with…
- Trial name
- NCT05306340
- Testing
- Giredestrant, Exemestane, Fulvestrant
- Where
- 136 sites in United States, Argentina and 11 more
- Volunteers
- 373 people
- Sponsor
- Genentech, Inc.
Metastatic Breast Cancer
Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
The goal of this clinical trial is to assess the efficacy, safety and tolerability of the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for the treatment of pre- and postmenopausal women and…
- Trial name
- ELAINEIII (NCT05696626)
- Testing
- Lasofoxifene in combination with abemaciclib, Fulvestrant in combination with abemaciclib
- Where
- 224 sites in United States, Australia and 15 more
- Volunteers
- 600 people
- Sponsor
- LeonaBio
Advanced Breast Cancer
Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.
The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.
- Trial name
- MONALEESA-3 (NCT02422615)
- Testing
- Ribociclib, Fulvestrant
- Where
- 174 sites in United States, Australia and 28 more
- Volunteers
- 726 people
- Sponsor
- Novartis Pharmaceuticals