Clinical trials: ER+ / HER2- Advanced Breast Cancer
Advanced Solid Tumors, Metastatic Breast Cancer
Dose Finding Study of RAD001 (Everolimus, Afinitor®) in Combination With BEZ235 in Patients With Advanced Solid Tumors
Study has two parts: 1. Dose-finding: to determine the maximum tolerated dose (MTD) and to evaluate the safety and tolerability of RAD001 (everolimus , Afinitor®) in combination with BEZ235 in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors, Metastatic Breast Cancer, Metastatic Renal Cell Carcinoma
- Trial name
- NCT01482156
- Testing
- RAD001 + BEZ235
- Where
- 10 sites in United States, Belgium and 5 more
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Phase I/II Trial to Evaluate Oral HP568 Tablets in Patients with ER+/HER2 Advanced Breast Cancer
This is a Phase 1/2 dose escalation and cohort expansion study and will assess the safety, tolerability and preliminary efficacy of HP568 alone and in combination with palbociclib in patients with ER+/HER2- locally advanced or…
- Trial name
- NCT06757335
- Testing
- HP568, HP568 in combination with palbociclib
- Volunteers
- 204 people
- Sponsor
- Hinova Pharmaceuticals Inc.
Estrogen Receptor Negative, HER2/Neu Negative
RO4929097 and Vismodegib in Treating Patients With Breast Cancer That is Metastatic or Cannot Be Removed By Surgery
This phase I trial studies the side effects and best dose of RO4929097 (gamma-secretase/Notch signalling pathway inhibitor RO4929097) when given together with vismodegib in treating patients with breast cancer that is metastatic…
- Conditions
- Estrogen Receptor Negative, HER2/Neu Negative, Progesterone Receptor Negative, Recurrent Breast Carcinoma
- Trial name
- NCT01071564
- Testing
- Gamma-Secretase Inhibitor RO4929097, Laboratory Biomarker Analysis, Pharmacogenomic Study
- Where
- 3 sites in United States
- Volunteers
- 13 people
- Sponsor
- National Cancer Institute (NCI)
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
Estrogen Receptor-positive (ER+)/Human Epidermal Growth Factor Receptor (HER2)-Negative Locally Advanced or Metastatic Breast Cancer
A Phase II Study Comparing The Efficacy Of Venetoclax + Fulvestrant Vs. Fulvestrant In Women With Estrogen Receptor-Positive, Her2-Negative Locally Advanced Or Metastatic Breast Cancer Who Experienced Disease Recurrence Or Progression During Or After CDK4/6 Inhibitor Therapy
This is a Phase II, multicenter, open-label, randomized study to compare the efficacy of venetoclax in combination with fulvestrant compared with fulvestrant alone in women with ER+, HER2-negative, locally advanced or Metastatic…
- Trial name
- Veronica (NCT03584009)
- Testing
- Venetoclax, Fulvestrant
- Where
- 40 sites in United States, Australia and 3 more
- Volunteers
- 103 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients
Men and post- or induced menopausal women with ER[+] and/or PgR[+], HER2[- ] advanced BC, with centrally-confirmed PI3KCAMut who progressed to an aromatase inhibitor (AI) regimen.
- Trial name
- METALLICA (NCT04300790)
- Testing
- Alpelisib, Metformin, Fulvestrant
- Where
- 19 sites in Spain
- Volunteers
- 69 people
- Sponsor
- MedSIR
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.
HR+/HER2- Advanced Breast Cancer
Albumin-bound Paclitaxel、Dalpiciclib and AI in ER-Low (1%-10%) HER2-ABC
This is a prospective, single-arm, single-center, open, exploratory clinical study.. Screening for histopathologically confirmed recurrent or metastatic ER-Low positive (1%-10%) and HER2-negative breast cancer patients who meet…
- Trial name
- NCT06711094
- Testing
- Dalpiciclib
- Volunteers
- 52 people
- Sponsor
- Fujian Medical University
Breast Neoplasms
Safety, Tolerability, Pharmacokinetics and Antitumor Activity of FCN-437c
This is a multicenter, open, single arm dose escalation and dose expansion clinical study to evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of FCN-437c alone or in combination with letrozole in women…
- Trial name
- NCT04488107
- Testing
- FCN-437c, Letrozole 2.5mg
- Where
- China
- Volunteers
- 78 people
- Sponsor
- Ahon Pharmaceutical Co., Ltd.
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
- 19 sites in Japan
- Volunteers
- 70 people
- Sponsor
- Stemline Therapeutics, Inc.
Breast Cancer
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
A phase 1b study to assess the combination of ARV-471 and everolimus in participants with advanced or metastatic ER+/HER2- breast cancer.
- Trial name
- TACTIVE-E (NCT05501769)
- Testing
- ARV-471 in combination with Everolimus
- Where
- 9 sites in United States, Spain
- Volunteers
- 32 people
- Sponsor
- Arvinas Estrogen Receptor, Inc.
Triple Negative Breast Cancer, Locally Advanced Breast Cancer
PAveMenT: Palbociclib and Avelumab in Metastatic AR+ Triple Negative Breast Cancer
This clinical study is aiming to determine the safest doses and schedule for the combination of two drugs named palbociclib and avelumab.
- Conditions
- Triple Negative Breast Cancer, Locally Advanced Breast Cancer, Recurrent Breast Cancer, Metastatic Breast Cancer
- Trial name
- PAveMenT (NCT04360941)
- Testing
- Palbociclib, Avelumab
- Where
- 9 sites in United Kingdom
- Volunteers
- 45 people
- Sponsor
- Royal Marsden NHS Foundation Trust
Breast Adenocarcinoma, Estrogen Receptor- Negative Breast Cancer
Neoadjuvant Pembrolizumab + Decitabine Followed by Std Neoadj Chemo for Locally Advanced HER2- Breast Ca
This study is a 2-cohort, open-label, multicenter, phase 2 study of a short course of immunotherapy consisting of sequential decitabine followed by pembrolizumab administered prior to a standard neoadjuvant chemotherapy regimen…
- Conditions
- Breast Adenocarcinoma, Estrogen Receptor- Negative Breast Cancer, Estrogen Receptor-positive Breast Cancer, HER2/Neu Negative
- Trial name
- NCT02957968
- Testing
- Doxorubicin, Cyclophosphamide, Paclitaxel
- Where
- 4 sites in United States
- Volunteers
- 46 people
- Sponsor
- Virginia Commonwealth University
Brain Cancer, Breast Cancer
18-F-Fluoroacetate as PET Imaging Agent
The goal of this clinical research study is to find out the highest tolerable dose of an imaging solution called 18-F-fluoroacetate sodium that can be given before a positron emission tomography (PET) scan.
- Conditions
- Brain Cancer, Breast Cancer, Prostate Cancer
- Trial name
- NCT01320787
- Testing
- 18F-fluoroacetate
- Sponsor
- M.D. Anderson Cancer Center
Advanced Breast Cancer
Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor
The purpose of this study is to learn if certain drug combinations are effective treatments for patients with advanced ER+/HER2- who have previously been treated with palbociclib, ribociclib, or abemaciclib.
- Trial name
- GERTRUDE (NCT05933395)
- Testing
- Fulvestrant, Neratinib, Alpelisib
- Where
- United States
- Volunteers
- 135 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
Estrogen Receptor Negative, HER2/Neu Negative
Trametinib and Akt Inhibitor GSK2141795 in Treating Patients With Metastatic Triple-Negative Breast Cancer
This phase II trial studies how well trametinib and v-akt murine thymoma viral oncogene homolog 1 (Akt) inhibitor GSK2141795 work in treating patients with triple-negative breast cancer (breast cancer cells that do not have…
- Conditions
- Estrogen Receptor Negative, HER2/Neu Negative, Invasive Breast Carcinoma, Progesterone Receptor Negative
- Trial name
- NCT01964924
- Testing
- Akt Inhibitor GSK2141795, Laboratory Biomarker Analysis, Trametinib
- Where
- 8 sites in United States
- Volunteers
- 37 people
- Sponsor
- National Cancer Institute (NCI)
Advanced Adult Primary Liver Cancer, Carcinoma of the Appendix
7-Hydroxystaurosporine and Irinotecan Hydrochloride in Treating Patients With Metastatic or Unresectable Solid Tumors or Triple Negative Breast Cancer (Currently Accruing Only Triple-negative Breast Cancer Patients Since 6/8/2007)
This phase I trial is studying the side effects and best dose of giving 7-hydroxystaurosporine together with irinotecan hydrochloride in treating patients with metastatic or unresectable solid tumors, including triple-negative…
- Conditions
- Advanced Adult Primary Liver Cancer, Carcinoma of the Appendix, Estrogen Receptor-negative Breast Cancer, Extensive Stage Small Cell Lung Cancer
- Trial name
- NCT00031681
- Testing
- 7-hydroxystaurosporine, irinotecan hydrochloride, diagnostic laboratory biomarker analysis
- Where
- United States
- Volunteers
- 41 people
- Sponsor
- National Cancer Institute (NCI)
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
- 18 sites in United States
- Volunteers
- 361 people
- Sponsor
- NiKang Therapeutics, Inc.
Breast Cancer, Metastatic Breast Cancer
AUY922 With Lapatinib and Letrozole for ER+ HER2+ Advanced Breast Cancer
The purpose of this study is to find out what effects, administering infusions of AUY922 with hormonal therapy (letrozole) and oral targeted drug (lapatinib) will have on the patients with advanced breast cancer known as ER+ HER2…
- Conditions
- Breast Cancer, Metastatic Breast Cancer, HER-2 Positive Breast Cancer, ER Positive Breast Cancer
- Trial name
- NCT01361945
- Testing
- AUY922
- Sponsor
- Texas Tech University Health Sciences Center, El Paso
Breast Cancer
Two Different Schedules of Palbociclib + Second Line Endocrine Therapy in Estrogen Receptor Positive, HER2 Neg Advanced/Metastatic Breast Cancer
The purpose of this study is to determine if the combination of endocrine therapy and Palbociclib at a daily dose of 100 mg will result in a better response to therapy with fewer dose interruptions than the proposed dosing…
- Trial name
- NCT02630693
- Testing
- Palbociclib 100mg, Palbociclib 125mg, Fulvestrant or Tamoxifen or Aromatase Inhibitor
- Where
- 22 sites in Canada
- Volunteers
- 180 people
- Sponsor
- Canadian Cancer Trials Group