Clinical trials: ER+ / HER2- Advanced Breast Cancer
Breast Neoplasms
A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)
The study is designed to compare the clinical benefit following treatment with letrozole in combination with PD-0332991 versus letrozole in combination with placebo in postmenopausal women with ER(+)/HER2(-) advanced breast…
- Trial name
- NCT01740427
- Testing
- PD-0332991, Letrozole
- Where
- 305 sites in United States, Australia and 16 more
- Volunteers
- 666 people
- Sponsor
- Pfizer
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
Breast Cancer
Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive and Estrogen Receptor/Progesterone Receptor Negative Breast Cancer to Evaluate the Efficiency and Safety of Treatment With Trastuzumab Plus (+) QL1209/Pertuzumab + Docetaxel.
This is a randomized, double-blind, multicenter trial，parallel control designed to evaluate treatment with trastuzumab + QL1209 + docetaxel compared with trastuzumab + pertuzumab + docetaxel in the participants with early-stage…
- Trial name
- NCT04629846
- Testing
- Trastuzumab, QL1209, Pertuzumab
- Where
- 2 sites in China
- Volunteers
- 517 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
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.
Breast Neoplasms
A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01)
The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC)…
- Trial name
- NCT06926868
- Testing
- Iza-bren, Nab-paclitaxel, Paclitaxel
- Where
- 295 sites in United States, Argentina and 26 more
- Volunteers
- 600 people
- Sponsor
- Bristol-Myers Squibb
Breast Neoplasms
A Study of LY3484356 in Chinese Participants With Advanced Breast Cancer
This is a study of LY3484356 in Chinese participants with advanced breast cancer. Participants must have breast cancer that is estrogen receptor positive (ER+), HER2 negative (HER2-).
- Trial name
- NCT05509790
- Testing
- LY3484356
- Where
- 4 sites in China
- Volunteers
- 17 people
- Sponsor
- Eli Lilly and Company
Receptors, Estrogen, Genes, Erbb-2
A Study of H3B-6545 in Combination With Palbociclib in Women With Advanced or Metastatic Estrogen Receptor-Positive Human Epidermal Growth Factor Receptor-2 (HER2)-Negative Breast Cancer
The primary objective of this study is to evaluate the safety and tolerability of H3B-6545 and palbociclib when administered in combination in order to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2…
- Conditions
- Receptors, Estrogen, Genes, Erbb-2, Breast Neoplasms
- Trial name
- NCT04288089
- Testing
- Palbociclib (75, 100, 125 milligram [mg]), H3B-6545 (150, 300, 450 mg)
- Where
- 8 sites in United States, United Kingdom
- Volunteers
- 31 people
- Sponsor
- Eisai Inc.
Advanced Metastatic Breast Cancer
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a…
- Trial name
- MONALEESA-7 (NCT02278120)
- Testing
- Ribociclib, Tamoxifen, Letrozole
- Where
- 183 sites in United States, Argentina and 28 more
- Volunteers
- 672 people
- Sponsor
- Novartis Pharmaceuticals
Advanced Breast Cancer, Metastatic Breast Cancer
Study of NUV-422 in Combination With Fulvestrant in Patients With HR+HER2- aBC
NUV-422-03 is a randomized, non-comparative Phase 1/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with fulvestrant relative to NUV-422 monotherapy and fulvestrant…
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer, Breast Cancer, Breast Carcinoma
- Trial name
- NCT05191004
- Testing
- NUV-422, Fulvestrant
- Where
- 5 sites in United States
- Sponsor
- Nuvation Bio Inc.
Neoplasms, Breast Neoplasms
A Study Of Oral Palbociclib (PD-0332991), A CDK4/6 Inhibitor, As Single Agent In Japanese Patients With Advanced Solid Tumors Or In Combination With Letrozole For The First-Line Treatment Of Postmenopausal Japanese Patients With ER (+) HER2 (-) Advanced Breast Cancer
This study is comprised of two portions: a Phase 1 portion and a Phase 2 portion. The Phase 1 portion is a single-country, non-randomized, open label, clinical trial which will evaluate the safety, tolerability, preliminary…
- Trial name
- NCT01684215
- Testing
- PD-0332991, letrozole
- Where
- 16 sites in Japan
- Volunteers
- 61 people
- Sponsor
- Pfizer
Breast Cancer
A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer
This is a multicenter, open-label, Phase 2 bridging study to evaluate the efficacy and safety of elacestrant in Japanese post-menopausal women and men with estrogen receptor positive (ER+)/human epidermal growth factor receptor 2…
- Trial name
- NCT07766018
- Testing
- Elacestrant
- Where
- 26 sites in Japan
- Volunteers
- 70 people
- Sponsor
- Stemline Therapeutics, Inc.
HR+ HER2- Metastatic Breast Cancer, Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer, Triple Negative Breast Cancer, Male Breast Cancer
A Study of PF-06873600 in People With Cancer
The purpose of this clinical trial is to learn about the safety and effects of study medicine (PF-06873600) when taken alone or with hormone therapy by people with cancer.
- Trial name
- NCT03519178
- Testing
- PF-06873600, Endocrine Therapy 1, Endocrine Therapy 2
- Where
- 54 sites in United States, Bulgaria and 4 more
- Volunteers
- 155 people
- Sponsor
- Pfizer
Neoplasms, Breast
Lapatinib and Bevacizumab for Metastatic Breast Cancer
This study will examine the efficacy and safety of lapatinib and bevacizumab in patients with ErbB2-overexpressing breast cancer.
- Trial name
- NCT00444535
- Testing
- lapatinib, bevacizumab
- Where
- 9 sites in United States
- Volunteers
- 52 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study of Multiple Immune and Disease Treatment Combinations in Participants With ER+HER2- Breast Cancer That Has Spread
The hypothesis of the CA048-001 Phase 1 clinical trial is targeting multiple mechanisms involved in generating and maintaining antitumor immune response will lead to a tolerable and robust anti-tumor response.
- Trial name
- NCT04132817
- Testing
- Nivolumab, Ipilimumab, Nab-paclitaxel
- Where
- 8 sites in United States
- Volunteers
- 12 people
- Sponsor
- Bristol-Myers Squibb
Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer
Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
The aim of this study is to identify the optimal dose for EP0062 as monotherapy and in combination with standard-of-care therapies to assess its Safety, Tolerability, Pharmacokinetics, and Efficacy in Patients with Relapsed…
- Conditions
- Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT05573126
- Testing
- EP0062, Elacestrant, Everolimus
- Where
- 14 sites in United States, Spain and 1 more
- Volunteers
- 95 people
- Sponsor
- Ellipses Pharma
Breast Cancer Metastatic
Phase 2 Study of Amcenestrant (SAR439859) Versus Physician's Choice in Locally Advanced or Metastatic ER-positive Breast Cancer
Primary Objective: To determine whether amcenestrant per overall survival (os) improves progression free survival (PFS) when compared with an endocrine monotherapy of the choice of the physician, in participants with metastatic…
- Trial name
- AMEERA-3 (NCT04059484)
- Testing
- Amcenestrant, Fulvestrant, Anastrozole
- Where
- 109 sites in United States, Argentina and 21 more
- Volunteers
- 367 people
- Sponsor
- Sanofi
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
Breast Cancer, Solid Tumors
A Study to Learn About the Study Medicine (Called PF-07220060 in Combination With PF-07104091) In Participants With Breast Cancer and Solid Tumors
The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called PF-07220060 and PF-07104091) in people with breast cancer. This clinical study consists of 2 parts (part 1 and part 2).
- Trial name
- NCT05262400
- Testing
- PF-07220060 + PF-07104091 combination dose escalation, PF-07104091 + PF-07220060 + fulvestrant dose expansion, PF-07104091 + PF-07220060 + letrozole dose expansion
- Where
- 44 sites in United States, Argentina and 7 more
- Volunteers
- 235 people
- Sponsor
- Pfizer
Breast Cancer
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
The purpose of this study is to assess the safety of GDC-4198 alone and in combination with giredestrant and also the efficacy of GDC-4198 + giredestrant versus abemaciclib + giredestrant in participants with locally advanced or…
- Trial name
- MoonROSE (NCT07100106)
- Testing
- GDC-4198, Giredestrant, Abemaciclib
- Where
- 77 sites in United States, Australia and 8 more
- Volunteers
- 285 people
- Sponsor
- Genentech, Inc.
Breast Cancer
Efficacy and Safety Study of Enzalutamide in Combination With Exemestane in Patients With Advanced Breast Cancer
The purpose of this study is to determine if enzalutamide given in combination with exemestane is safe and effective in patients with advanced breast cancer.
- Trial name
- NCT02007512
- Testing
- Enzalutamide, exemestane
- Where
- 135 sites in United States, Belgium and 5 more
- Volunteers
- 247 people
- Sponsor
- Pfizer