Clinical trials: ER+ HER2- Advanced Breast Cancer
Breast Cancer
Bendamustine and Erlotinib in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT00834678
- Testing
- bendamustine, erlotinib, Maintenance erlotinib
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Ohio State University Comprehensive Cancer Center
Breast Cancer
Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC
The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment…
- Trial name
- COMPLEEMENT-1 (NCT02941926)
- Testing
- Ribociclib, Letrozole, Goserelin
- Where
- 495 sites in United States, Argentina and 36 more
- Volunteers
- 3,246 people
- Sponsor
- Novartis Pharmaceuticals
Breast Neoplasms
Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer
This study evaluated and compared the efficacy and tolerability of lapatinib and letrozole, with letrozole and placebo in post-menopausal women with hormone receptor positive (ER positive and/or PgR positive) advanced or…
- Trial name
- NCT00073528
- Testing
- Lapatinib, Letrozole
- Where
- 278 sites in United States, Argentina and 27 more
- Volunteers
- 1,286 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Phase 3 Trial of Elacestrant Versus Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
This Phase 3 clinical study compares the efficacy and safety of elacestrant to the standard of care (SoC) options of fulvestrant or an aromatase inhibitor (AI) in women and men with breast cancer whose disease has advanced on at…
- Trial name
- EMERALD (NCT03778931)
- Testing
- Elacestrant, Standard of Care
- Where
- 244 sites in United States, Argentina and 15 more
- Volunteers
- 478 people
- Sponsor
- Stemline Therapeutics, Inc.
Breast Neoplasms
Clinical Study for the Treatment of Breast Cancer: the Patient Will Receive Afatinib Plus Letrozole or Letrozole Alone
The purpose of the study is to compare the efficacy of treatment with afatinib plus letrozole to treatment with letrozole alone in women diagnosed with a specific type of breast cancer.
- Trial name
- NCT02115048
- Testing
- Letrozole, Afatinib
- Where
- 26 sites in United States, Bosnia and Herzegovina and 2 more
- Volunteers
- 44 people
- Sponsor
- Translational Research in Oncology
Breast Neoplasms, Neoplasm Metastasis
A Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Participants With ER+, HER2- Advanced Breast Cancer
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy, and how well imlunestrant with abemaciclib work compared to imlunestrant in participants with breast cancer that is…
- Trial name
- EMBER-3 (NCT04975308)
- Testing
- Imlunestrant, Exemestane, Fulvestrant
- Where
- 243 sites in United States, Argentina and 20 more
- Volunteers
- 874 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
MEtronomic TrEatment Option in Advanced bReast cAncer
This is a multi-center, randomized phase II trial that will randomise women with ER-positive, HER2-negative (Human Epidermal Growth factor Receptor 2-negative) metastatic or locally relapsed breast cancer in a ratio of 1:1 to…
- Trial name
- METEORA-II (NCT02954055)
- Testing
- Paclitaxel, Cyclophosphamide, Capecitabine
- Where
- 20 sites in Italy
- Volunteers
- 140 people
- Sponsor
- ETOP IBCSG Partners Foundation
Breast Cancer
Study of Elacestrant in Combination With Onapristone in Patients With Advanced or Metastatic Breast Cancer
This is a multicenter, Phase 1b-2 study of elacestrant in combination with onapristone in patients with advanced/metastatic ER+/PgR+/HER2- breast cancer.
- Trial name
- ELONA (NCT05618613)
- Testing
- Elacestrant, Onapristone
- Where
- 3 sites in United States
- Volunteers
- 4 people
- Sponsor
- Context Therapeutics Inc.
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)
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
Breast Cancer
Amcenestrant (SAR439859) Plus Palbociclib as First Line Therapy for Patients With ER (+) HER2(-) Advanced Breast Cancer
Primary Objective: To determine whether Amcenestrant (SAR439859) in combination with palbociclib improves progression free survival (PFS) when compared with letrozole in combination with palbociclib in participants with estrogen…
- Trial name
- AMEERA-5 (NCT04478266)
- Testing
- SAR439859, Palbociclib, Letrozole
- Where
- 249 sites in United States, Argentina and 28 more
- Volunteers
- 1,068 people
- Sponsor
- Sanofi
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
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
Breast Neoplasms
A Study to Learn About the Vepdegestrant (ARV-471, PF-07850327) in People With ER+/HER2- Locally Advanced or Metastatic Breast Cancer (BC)
The purpose of this clinical trial is to learn about the safety, tolerability, Pharmacokinetics (PK), and preliminary efficacy of ARV-471 as monotherapy in Japanese participants with ER+/HER2- locally advanced or metastatic…
- Trial name
- NCT05463952
- Testing
- vepdegestrant
- Where
- 3 sites in Japan
- Volunteers
- 6 people
- Sponsor
- Pfizer
Estrogen Receptor-negative Breast Cancer, HER2-negative Breast Cancer
Nab-Paclitaxel and Bevacizumab Followed By Bevacizumab and Erlotinib in Metastatic Breast Cancer
This phase II trial studies how well giving paclitaxel albumin-stabilized nanoparticle (Nab-paclitaxel) formulation together with bevacizumab followed by bevacizumab and erlotinib hydrochloride work in treating patients with…
- Conditions
- Estrogen Receptor-negative Breast Cancer, HER2-negative Breast Cancer, Progesterone Receptor-negative Breast Cancer, Recurrent Breast Cancer
- Trial name
- NCT00733408
- Testing
- paclitaxel albumin-stabilized nanoparticle formulation, bevacizumab, erlotinib hydrochloride
- Where
- 17 sites in United States
- Volunteers
- 59 people
- Sponsor
- University of Washington
Breast Cancer
Fulvestrant Plus Enzalutamide in ER+/Her2- Advanced Breast Cancer
A phase 2 study to evaluate the tolerability and clinical activity of adding enzalutamide to fulvestrant treatment in women with advanced breast cancer that are ER and/or PR positive and Her2 normal.
- Trial name
- NCT02953860
- Testing
- Fulvestrant with Enzalutamide
- Where
- 3 sites in United States
- Volunteers
- 32 people
- Sponsor
- University of Colorado, Denver
Breast Cancer, HER2-negative Breast Cancer
Study of Infigratinib in Combination With Tamoxifen in Hormone Receptor Positive, HER2 Negative, FGFR Altered Advanced Breast Cancer
The purpose of the study is identify the dose(s) of infigratinib to use in combination with tamoxifen to treat patients with a particular type of advanced breast cancer (hormone receptor-positive, HER2-negative, FGFR-altered…
- Conditions
- Breast Cancer, HER2-negative Breast Cancer, ER Positive Breast Cancer, PR-Positive Breast Cancer
- Trial name
- NCT04504331
- Testing
- Infigratinib, Tamoxifen, Omnipaque 350
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Jennifer Lee Caswell-Jin
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
Advanced Breast Cancer
Palbociclib Pharmacokinetics Study In Postmenopausal Chinese Women With ER (+), HER2 (-) Advanced Breast Cancer
As part of the global clinical development program for Palbociclib, studies are planned in cancer patients in China. An assessment of Palbociclib pharmacokinetics in Chinese patients, as required by the Chinese Health…
- Trial name
- NCT02499146
- Testing
- Palbociclib, Letrozole
- Where
- 7 sites in China
- Volunteers
- 26 people
- Sponsor
- Pfizer