Clinical trials: ER+ / HER2- Advanced Breast Cancer
Metastatic Breast Cancer
Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer
This is an international, randomized, open-label, controlled, multicenter phase II clinical trial to investigate and compare the safety and efficacy of palbociclib combined with fulvestrant or letrozole in women with ER+, HER2…
- Trial name
- PARSIFAL (NCT02491983)
- Testing
- Palbociclib, Fulvestrant, Letrozole
- Where
- 48 sites in Czechia, France and 5 more
- Volunteers
- 486 people
- Sponsor
- MedSIR
Triple Negative Breast Cancer
A Study of NK012 in Patients With Advanced, Metastatic Triple Negative Breast Cancer
The purpose of this study is to determine whether NK012 is safe and effective in the treatment of advanced and metastatic triple negative breast cancer.
- Trial name
- NCT00951054
- Testing
- NK012
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Nippon Kayaku Co., Ltd.
Estrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer
Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer
Breast cancer is not only the leading cause of cancer in women, but also the leading cause of cancer deaths in women. Estrogen receptor-positive and HER2-negative breast cancer is the most prevalent breast cancer subtype.
- Conditions
- Estrogen-receptor-positive Breast Cancer, HER2/Neu-Negative Breast Cancer, Advanced Breast Cancerv, Metastatic Breast Cancer
- Trial name
- NCT06062498
- Testing
- elacestrant, palbociclib, abemaciclib, ribociclib
- Where
- 3 sites in United States
- Volunteers
- 174 people
- Sponsor
- Northwestern University
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
Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Giredestrant Compared With Physician's Choice of Endocrine Monotherapy in Participants With Previously Treated Estrogen Receptor-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer (acelERA Breast Cancer)
This Phase II, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant compared with physician's choice of endocrine monotherapy in participants with estrogen receptor (ER)-positive, human…
- Trial name
- NCT04576455
- Testing
- Giredestrant, Fulvestrant or an Aromatase Inhibitor (Physician Choice), LHRH Agonist
- Where
- 81 sites in United States, Argentina and 15 more
- Volunteers
- 303 people
- Sponsor
- Hoffmann-La Roche
ER-Positive HER2-Negative Breast Cancer
A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease
The study is intended to show superiority of AZD9833 in combination with palbociclib (a CDK4/6 inhibitor) versus anastrozole (an aromatase inhibitor) and palbociclib as the initial treatment of patients with hormone…
- Trial name
- SERENA-4 (NCT04711252)
- Testing
- AZD9833, Anastrozole, Palbociclib
- Where
- 263 sites in United States, Austria and 25 more
- Volunteers
- 1,371 people
- Sponsor
- AstraZeneca
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
Breast Cancer
Fulvestrant and Ipatasertib for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor
The purpose of this study is to find out whether a new drug, Ipatasertib, can slow the growth of advanced breast cancer when added to standard therapy (Fulvestrant).
- Trial name
- FINER (NCT04650581)
- Testing
- Ipatasertib, Fulvestrant
- Where
- 39 sites in Australia, Canada and 1 more
- Volunteers
- 250 people
- Sponsor
- Canadian Cancer Trials Group
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.
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 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
Metastatic Breast Cancer
Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029)
The purpose of this study is to assess the efficacy and safety of belzutifan (MK-6482) plus fulvestrant compared to everolimus plus endocrine therapy (ET) (investigator's choice of fulvestrant or exemestane) in adults with…
- Trial name
- NCT06428396
- Testing
- Belzutifan, Fulvestrant, Everolimus
- Where
- 41 sites in United States, Argentina and 7 more
- Volunteers
- 120 people
- Sponsor
- Merck Sharp & Dohme LLC
Metastatic Breast Cancer, Locally Advanced Breast Cancer
Impact of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER+/HER2- Breast Cancer
The purpose of this study is to perform an in depth analysis of changes in the tumor immune microenvironment in patients undergoing treatment with standard of care endocrine therapy and abemaciclib in the advanced setting via…
- Conditions
- Metastatic Breast Cancer, Locally Advanced Breast Cancer, Hormone Receptor Positive Tumor
- Trial name
- NCT04352777
- Testing
- Abemaciclib, Fulvestrant, Aromatase Inhibitors
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Duke University
Metastatic Breast Cancer, Breast Cancer Stage I
A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
This is a Study to Evaluate the Efficacy and Safety of Multiple Combination Therapies with FWD1802 in Subjects with ER-positive/HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Locally Advanced Breast Cancer (LABC)
- Trial name
- NCT07002177
- Testing
- FWD1802, Palbociclib 125mg, Ribociclib 200Mg Oral Tablet
- Where
- China
- Volunteers
- 196 people
- Sponsor
- Forward Pharmaceuticals Co., Ltd.
Advanced ER+/HER2- Breast Cancer
Phase Ib/II Clinical Study of QLS1304 Combined With Endocrine Therapy in the Treatment of ER+/HER2- Breast Cancer Patients
This study is a multi-center, open label, phase Ib/II clinical trial aimed at evaluating the safety, preliminary efficacy characteristic and PK characteristics of QLS1304 in combined with endocrine therapy in ER+/HER2- breast…
- Trial name
- NCT07235176
- Testing
- QLS1304 tablet+Fulvestrant or QLC1401, QLS1304 tablet+Fulvestrant，AI or QLC1401+CDK4/6i
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Metastatic Breast Cancer, ER+ Breast Cancer
Fulvestrant, Ipatasertib and CDK4/6 Inhibition in Metastatic ER+/HER2- Breast Cancer Patients Without ctDNA Suppression
Analysis of circulating tumour DNA (ctDNA) found in a patient's peripheral blood can identify cancer progression and predict a patient's response to therapy.
- Conditions
- Metastatic Breast Cancer, ER+ Breast Cancer, Advanced Breast Cancer
- Trial name
- FAIM (NCT04920708)
- Testing
- Ipatasertib 300mg, Fulvestrant 500g, Palbociclib 75mg-125mg
- Where
- 13 sites in United Kingdom
- Volunteers
- 57 people
- Sponsor
- Royal Marsden NHS Foundation Trust
Breast Cancer Stage IV, Radiotherapy
Locoregional Treatment and Palbociclib in de Novo, Treatment Naive, Stage IV ER+, HER2- Breast Cancer Patients
Approximately 3.5% to 6% of newly diagnosed breast cancer patients are stage IV metastatic. De novo metastatic breast cancer accounts for 20% to 25% of these cases.
- Conditions
- Breast Cancer Stage IV, Radiotherapy, Surgery
- Trial name
- PALATINE (NCT03870919)
- Testing
- Palbociclib, locoregional treatment
- Where
- 26 sites in France
- Volunteers
- 200 people
- Sponsor
- UNICANCER
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 Cancer
Study Evaluating Hemay022 in Combination With Endocrine Therapy In Subjects With ER Positive and HER2 Positive Advanced Breast Cancer
The purpose of this study is to evaluate the safety and tolerability of Hemay022 combined with endocrine therapy in the treatment of ER and HER2-positive metastatic or advanced breast cancer, and to establish OTR (best tolerated…
- Trial name
- NCT03308201
- Testing
- Hemay022+exemestane, Hemay022+letrozole, Hemay022+ fulvestrant
- Where
- China
- Volunteers
- 55 people
- Sponsor
- Tianjin Hemay Pharmaceutical Co., Ltd
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