Clinical trials: HR+/HER2- Locally Advanced, Metastatic Breast Cancer
Metastatic Breast Cancer, Locally Advanced Breast Cancer
A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer
This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advanced Hormone Receptor (HR)…
- Conditions
- Metastatic Breast Cancer, Locally Advanced Breast Cancer, Breast Cancer
- Trial name
- SUMIT-ELA (NCT05963997)
- Testing
- Samuraciclib, Elacestrant Dihydrochloride
- Where
- 23 sites in United States, France and 2 more
- Volunteers
- 49 people
- Sponsor
- Carrick Therapeutics Limited
Advanced or Metastatic Breast Cancer
Dose Escalation Study of LEE011 in Combination With Buparlisib and Letrozole in HR+, HER2-negative Post-menopausal Women With Advanced Breast Cancer.
This is a multi-center, open-label, non-randomized, phase I study
- Trial name
- LeeBLet (NCT02154776)
- Testing
- LEE011, Buparlisib, Letrozole
- Where
- 6 sites in United States, Spain
- Volunteers
- 13 people
- Sponsor
- Novartis Pharmaceuticals
Locally Advanced (Inoperable) or Metastatic Breast Cancer
Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer
Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer…
- Trial name
- CAPItello-291 (NCT04305496)
- Testing
- Fulvestrant, Capivasertib
- Where
- 215 sites in United States, Argentina and 17 more
- Volunteers
- 818 people
- Sponsor
- AstraZeneca
Breast Neoplasms
Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive, HER2-low Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy, safety and tolerability of RC48-ADC with JS001 compared with RC48-ADC in endocrine-resistant hormone receptor (HR) positive, human epidermal growth factor receptor (HER)2-low advanced breast…
- Trial name
- NCT06105008
- Testing
- Disitamab Vedotin, Toripalimab
- Where
- 3 sites in China
- Sponsor
- RemeGen Co., Ltd.
Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC)
JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer
This is a multicenter, open-label, Phase Ib/II randomized study designed to evaluate the safety, tolerability, dose-limiting toxicities (DLTs), and preliminary antitumor activity of JSKN016 in combination with the oral selective…
- Trial name
- NCT07336771
- Testing
- JSKN016 Q2W, JSKN016 Q3W, D-0502
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
Breast Cancer
Trial of BKM120/Tamoxifen-combination in Patients With HR-pos, HER2-neg Breast Cancer
This is a clinical trial with a molecularly stratified parallel cohort, single arm design to explore the efficacy and safety of BKM120 in combination with tamoxifen in patients with ER/PR-positive, HER2-negative breast cancer…
- Trial name
- PIKTAM (NCT02404844)
- Testing
- BKM120, Tamoxifen
- Where
- Germany
- Volunteers
- 48 people
- Sponsor
- University Hospital, Essen
Breast Cancer
A Study of GB491 in Combination With Letrozole in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
The main purpose of this study is to evaluate the efficacy and safety of GB491 combined with Letrozole versus placebo combined with Letrozole in the treatment of HR+/HER2- locally advanced or metastatic breast cancer without…
- Trial name
- NCT05851014
- Testing
- GB491 combined with Letrozole
- Where
- 52 sites in China
- Volunteers
- 350 people
- Sponsor
- Genor Biopharma Co., Ltd.
Breast Cancer
A Phase ll, Interventional, Single-arm Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib and Fulvestrant in Chinese Patients With PIK3CA-mutant, HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer.
This is a prospective, multicenter, open-label, single-arm phase II investigator-initiated study designed to evaluate the efficacy and safety of inavolisib in combination with ribociclib and fulvestrant as first-line treatment in…
- Trial name
- NCT07618390
- Testing
- Inavolisib + Ribociclib + Fulvestrant
- Volunteers
- 160 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Metastatic Breast Cancer
Study of SKB264 for Locally Advanced, Recurrent or Metastatic HR+/HER2- Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of SKB264 in patients with unresectable locally advanced, recurrent, or metastatic HR+/HER2- breast cancer.
- Trial name
- NCT06081959
- Testing
- SKB264, Eribulin, Capecitabine
- Where
- China
- Volunteers
- 376 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Breast Cancer
Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer
To compare the combination of Ribociclib plus goserelin acetate with hormonal therapy versus combination chemotherapy in premenopausal or perimenopausal patients with advanced or metastatic breast cancer
- Trial name
- RIGHT Choice (NCT03839823)
- Testing
- Docetaxel / Capecitabine, Capecitabine / Vinorelbine, Paclitaxel / Gemcitabine
- Where
- 50 sites in Egypt, India and 11 more
- Volunteers
- 222 people
- Sponsor
- Novartis Pharmaceuticals
Breast Neoplasms
A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
The purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal…
- Trial name
- NCT06312176
- Testing
- Sacituzumab tirumotecan, Pembrolizumab, Paclitaxel
- Where
- 259 sites in United States, Argentina and 38 more
- Volunteers
- 1,200 people
- Sponsor
- Merck Sharp & Dohme LLC
HR+/HER2- Advanced/Metastatic Breast Cancer
Sirolimus for Injection (Albumin-bound) Combined With Fulvestrant for HR+/HER2- Advanced/Metastatic Breast Cancer Patients Previously Treated With CDK4/6 Inhibitors
A randomized, double-blind, multicenter phase III clinical study to evaluate the efficacy and safety of sirolimus for injection (albumin-bound) combined with fulvestrant in patients with HR+ and HER2- advanced breast cancer.
- Trial name
- NCT06929325
- Testing
- Sirolimus for Injection (Albumin-bound), Fulvestrant Injection
- Where
- China
- Volunteers
- 312 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Locally Advanced or Metastatic Breast Cancer
GB491 Combined With Fulvestrant for HR+ HER2- Locally Advanced or Metastatic Breast Cancer
GB491-004 is a multicenter, randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of GB491 in combination with fulvestrant in patients with HR-positive, HER2-negative locally advanced or…
- Trial name
- NCT05054751
- Testing
- GB491+ Fulvestrant
- Where
- 54 sites in China
- Volunteers
- 275 people
- Sponsor
- Genor Biopharma Co., Ltd.
Locally Advanced or Metastatic Breast Cancer
A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC
This study is a multicenter, open-label, phase 2 clinical study to evaluate the efficacy, safety and pharmacokinetics of YL202 in patients with locally advanced or metastatic breast cancer with TNBC, HR-positive…
- Trial name
- NCT06439771
- Testing
- YL202 should be intravenously infused
- Where
- China
- Volunteers
- 180 people
- Sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
Advanced Solid Tumors
A Study to Evaluate ATX-898 in Participants With Advanced Solid Tumors
Study ATX-898-101 is a phase 1/2 open-label study evaluating the safety, tolerability, pharmacokinetic, and preliminary efficacy of ATX-898 as monotherapy and in combination with anti-neoplastic agents in selected solid tumors.
- Trial name
- NCT07767474
- Testing
- ATX-898, ATX-898, fulvestrant, ribociclib
- Where
- 6 sites in United States, Australia
- Volunteers
- 343 people
- Sponsor
- Antares Therapeutics, Inc
Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer
Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer
Trial design: Phase II, prospective, multi-center, randomized, open label, parallel group study in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutation, with 2:1…
- Conditions
- Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- Trial name
- ELEMENT (NCT06201234)
- Testing
- Olaparib + Elacestrant, Olaparib
- Where
- 36 sites in Germany
- Volunteers
- 176 people
- Sponsor
- GBG Forschungs GmbH
Metastatic Breast Cancer, Locally Advanced Breast Cancer
HOPE: Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, HR+, HER2-metastatic Breast Cancer
The main purpose of this research study is to learn whether the investigational combination of olaparib, palbociclib, and fulvestrant is safe in patients with estrogen receptor-positive breast cancer and BRCA1 or BRCA2 mutations.
- Conditions
- Metastatic Breast Cancer, Locally Advanced Breast Cancer, Advanced Breast Cancer, BRCA2 Mutation
- Trial name
- NCT03685331
- Testing
- Palbociclib, Olaparib, Fulvestrant
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Breast Cancer Metastatic
ABemaciclib, ET ± paclItaxel in aGgressive HR+/HER2- MBC trIaL
This is a multicenter, randomized, 2 arm, open label, phase II study. It is designed to compare the efficacy and safety of abemaciclib combined with ET (letrozole or fulvestrant) versus a short course with induction chemotherapy…
- Trial name
- ABIGAIL (NCT04603183)
- Testing
- Abemaciclib, Paclitaxel, Letrozole
- Where
- 31 sites in Italy, Portugal and 1 more
- Volunteers
- 162 people
- Sponsor
- MedSIR
Advanced, Metastatic Breast Cancer
A Study to Investigate the Efficacy and Safety of Letrozole SIE Compared With Femara® (Both Combined With the CDK4/6 Inhibitor Ribociclib) in Postmenopausal Women With HR-Positive, HER2-Negative, Inoperable Locally Advanced or Metastatic Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of Letrozole SIE (injectable) compared to Femara® (oral tablet), both given together with ribociclib, for the first-line treatment of postmenopausal women with…
- Trial name
- SIE-3 (NCT07340658)
- Volunteers
- 300 people
- Sponsor
- Rovi Pharmaceuticals Laboratories
PIK3CA Mutation, HER2- Negative Breast Cancer
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with…
- Conditions
- PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer
- Trial name
- ReDiscover-2 (NCT06982521)
- Testing
- Zovegalisib, Capivasertib, Fulvestrant
- Where
- 243 sites in United States, Argentina and 25 more
- Volunteers
- 540 people
- Sponsor
- Relay Therapeutics, Inc.