Clinical trials: Estrogen Receptor- Negative Breast Cancer
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.
Breast Neoplasms
A Study of Imlunestrant Versus Standard Endocrine Therapy in Participants With Early Breast Cancer
The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2…
- Trial name
- EMBER-4 (NCT05514054)
- Testing
- Imlunestrant, Tamoxifen, Anastrozole
- Where
- 672 sites in United States, Argentina and 29 more
- Volunteers
- 8,000 people
- Sponsor
- Eli Lilly and Company
Breast Neoplasms
Study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant
The purpose of this study to Assess the Efficacy and Safety of the Epigenetic Modifying Effects of CC-486 (Oral Azacitidine) in Combination With Fulvestrant in Postmenopausal Women with estrogen receptor positive (ER+), human…
- Trial name
- NCT02374099
- Testing
- CC-486, Fulvestrant
- Where
- 35 sites in United States, Belgium and 4 more
- Volunteers
- 97 people
- Sponsor
- Celgene
ER+ HER2- Advanced Breast Cancer
A Phase 1 Study of AZD9833 in Japanese Women With ER Positive, HER2 Negative Advanced Breast Cancer
This is a Phase 1, open-label study designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of AZD9833 in Japanese women with endocrineresistant ER+ HER2- breast cancer that is not amenable to…
- Trial name
- NCT04541433
- Testing
- AZD9833
- Where
- 3 sites in Japan
- Volunteers
- 10 people
- Sponsor
- AstraZeneca
Primary Invasive Breast Cancer
EndoPredict® Extended Endocrine Trial (EXET)
The purpose of this study is to evaluate the impact of using EndoPredict® clinically to inform treatment decisions for extended endocrine therapy, and the subsequent impact on patient outcomes.
- Trial name
- NCT04016935
- Testing
- Observational
- Where
- 52 sites in United States
- Volunteers
- 855 people
- Sponsor
- Myriad Genetic Laboratories, Inc.
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.
Advanced Solid Tumors, Metastatic Triple Negative Breast Cancer
Study of NK012 and Carboplatin in Solid Tumors With Dose Expansion in Triple Negative Breast Cancer
The primary objective is to determine the maximum tolerated dose/recommended phase II dose of the combination regimen of NK012 and carboplatin in patients with advanced solid tumors.
- Trial name
- NCT01238952
- Testing
- NK012 and carboplatin
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Nippon Kayaku Co., Ltd.
Advanced Breast Cancer
AZD2171 in Addition to Fulvestrant in Patients With Advanced Breast Cancer.
The purpose of this study is to determine whether AZD2171 can effectively improve time to tumour progression when added to fulvestrant in patients with advanced hormone sensitive breast cancer who progressed on prior hormonal…
- Trial name
- NCT00454805
- Testing
- AZD2171, Fulvestrant
- Where
- 16 sites in United States, Australia and 1 more
- Volunteers
- 75 people
- Sponsor
- AstraZeneca
Advanced Breast Cancer
Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer
A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a…
- Trial name
- SERENA-1b (NCT07427394)
- Testing
- Camizestrant, Atirmociclib
- Where
- 6 sites in United States, United Kingdom
- Volunteers
- 24 people
- Sponsor
- AstraZeneca
Metastatic Breast Cancer
4EVER - Efficacy, Safety, Health Economics, Translational Research of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer
The present multi-center, open-label, single-arm study aims to evaluate the efficacy and safety, quality of life and health resources utilization in postmenopausal women with hormone receptor positive breast cancer progressing…
- Trial name
- MACS2096 (NCT01626222)
- Testing
- Exemestane, Everolimus (RAD001)
- Where
- 84 sites in Germany
- Volunteers
- 301 people
- Sponsor
- Novartis Pharmaceuticals
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
Metastatic ER+ Breast Cancer
Study of TTC-352 in Patients With Metastatic Breast Cancer Progressing on Endocrine Therapy
Phase1 study of TTC 352 for treatment of metastatic ER+ breast cancer.
- Trial name
- NCT03201913
- Testing
- TTC-352
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- TTC Oncology, LLC
Breast Neoplasms, Brain Neoplasms
Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
This is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth…
- Conditions
- Breast Neoplasms, Brain Neoplasms, Neoplasms by Site, Neoplasms
- Trial name
- ELECTRA (NCT05386108)
- Testing
- Elacestrant, Abemaciclib
- Where
- 86 sites in United States, Belgium and 8 more
- Volunteers
- 73 people
- Sponsor
- Stemline Therapeutics, Inc.
Breast Cancer
Study of BCD-115 in Women With ER(+) HER2(-) Local Advanced and Metastatic Breast Cancer
A Multicenter Open-label Non-comparative 2-Stage Phase 1a/1b Study to Assess the Safety and Pharmacokinetics of Oral BCD-115 (JSC BIOCAD, Russia) in Combination with Endocrine Therapy in Women with ER(+) HER2(-) Local Advanced…
- Trial name
- NCT03065010
- Testing
- BCD-115
- Where
- Russia
- Volunteers
- 6 people
- Sponsor
- Biocad
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
Triple Negative Breast Neoplasms
A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer
This study is designed to determine the efficacy and safety of durvalumab in combination with novel oncology therapies with or without paclitaxel and durvalumab + paclitaxel for first-line metastatic triple negative breast cancer
- Trial name
- BEGONIA (NCT03742102)
- Testing
- Durvalumab, Capivasertib, Oleclumab
- Where
- 32 sites in United States, Canada and 4 more
- Volunteers
- 243 people
- Sponsor
- AstraZeneca
Advanced Solid Malignancies, Breast Cancer - ER+, HER2 -
Phase I, Dose Study to Look at the Safety and Pharmacokinetics of AZD8835 in Patients With Advanced Solid Tumours
First time in patients study of AZD8835. The study has four parts. Part A AZD8835 is administered as a single agent in a multiple ascending dose escalation phase to investigate dose level for monotherapy.
- Conditions
- Advanced Solid Malignancies, Breast Cancer - ER+, HER2 -, Breast Cancer - ER+, HER2-, PIK3CA Gene Mutation
- Trial name
- NCT02260661
- Testing
- AZD8835, AZD8835 in combination with fulvestrant
- Where
- 9 sites in United States, United Kingdom
- Volunteers
- 20 people
- Sponsor
- AstraZeneca
Early Breast Cancer
A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)
This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with physician's choice of endocrine therapy in participants with medium- and high-risk…
- Trial name
- NCT04961996
- Testing
- Giredestrant, Physician's Choice of Endocrine Therapy, LHRH Agonist
- Where
- 621 sites in United States, Argentina and 52 more
- Volunteers
- 4,170 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer
Efficacy & Safety Evaluation of Enobosarm in Combo With Abemaciclib in Treatment of ER+HER2- Metastatic Breast Cancer
STAGE 1: To determine the safety of enobosarm 9 milligram (mg) once daily (QD) used in combination with a CDK 4/6 inhibitor [Verzenio® (abemaciclib) tablets, for oral use, 150 mg twice daily (BID)].
- Trial name
- VERU-024 (NCT05065411)
- Testing
- Enobosarm & Abemaciclib Combo, non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant
- Where
- 30 sites in United States
- Volunteers
- 5 people
- Sponsor
- Veru Inc.
Breast Cancer
Comparative Study of Oestradiol Suppression: Zoladex 10.8mg/3 Month vs. 3.6mg/Month in ER +ve EBC Pre-menopausal Patients
The primary purpose of this study is to establish if a 10.8 mg dose of ZOLADEX given 3 monthly is non-inferior to a 3.6 mg dose of ZOLADEX given monthly in terms of oestradiol suppression in patients with oestrogen receptor…
- Trial name
- NCT00303524
- Testing
- Goserelin acetate
- Where
- 22 sites in Japan
- Volunteers
- 170 people
- Sponsor
- AstraZeneca