Clinical trials: Locally Advanced or Metastatic Breast Cancer
- Condition Locally Advanced or Metastatic Breast Cancer
- Funder type Industry (pharma, biotech, devices)
Triple Negative Breast Cancer (TNBC)
Study of B013 and Nab-Paclitaxel for Locally Advanced or Metastatic Triple Negative Breast Cancer
This Phase II/III study assessed the efficacy, safety, pharmacokinetics, and immunogenicity of B013 administered with nab-paclitaxel in participants with locally advanced or metastatic triple negative breast cancer (TNBC) who…
- Trial name
- NCT05555706
- Testing
- B013+Nab-Paclitaxel
- Where
- 13 sites in China
- Volunteers
- 62 people
- Sponsor
- Shanghai Jiaolian Drug Research and Development Co., Ltd
Triple-Negative Breast Cancer (TNBC)
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
This Phase Ib/IIa study is evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of MR001 in patients with advanced triple-negative breast cancer (TNBC) who have progressed after prior therapy.
- Trial name
- NCT07208149
- Testing
- MR001 Bispecific Antibody for Injection
- Where
- China
- Volunteers
- 42 people
- Sponsor
- Shenzhen Majory Biotechnology Co., Ltd.
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
Triple Negative Breast Cancer
A Study to Evaluate the Efficacy and Safety of Nanosomal Docetaxel Lipid Suspension in Triple Negative Breast Cancer Patients
The Nanosomal Docetaxel Lipid Suspension (NDLS) consists of uniformly sized micro particles of docetaxel suspended in a lipid based formulation.
- Trial name
- NCT03671044
- Testing
- Nanosomal Docetaxel Lipid Suspension (75 mg/m2), Nanosomal Docetaxel Lipid Suspension (100 mg/m2), Taxotere® (100 mg/m2)
- Where
- 4 sites in United States, India
- Volunteers
- 657 people
- Sponsor
- Jina Pharmaceuticals Inc.
Hormone Receptor Positive Breast Cancer, HER-2 Positive Breast Cancer
A Study of Abemaciclib (LY2835219) in Women With HR+, HER2+ Locally Advanced or Metastatic Breast Cancer
The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care chemotherapy in women with hormone receptor…
- Trial name
- monarcHER (NCT02675231)
- Testing
- Abemaciclib, Trastuzumab, Fulvestrant
- Where
- 93 sites in United States, Argentina and 12 more
- Volunteers
- 237 people
- Sponsor
- Eli Lilly and Company
Locally Advanced or Metastatic Malignant Solid Tumors
A Study of ASP2998 Given by Itself and Given With Standard Therapies in People With Solid Tumors
Specific proteins found in tumors help the tumors spread and grow. People with solid tumors often have a protein called TROP2 in their tumor.
- Trial name
- NCT07287995
- Testing
- ASP2998, Pembrolizumab, Enfortumab Vedotin
- Where
- 9 sites in United States, Japan
- Volunteers
- 428 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Locally Advanced Breast Cancer, Metastatic Breast Cancer
Efficacy and Safety of Tenalisib (RP6530), in Patients With Locally Advanced or Metastatic Breast Cancer
Phase II, randomized, open-label study, designed to evaluate the preliminary efficacy and safety of tenalisib at two dose levels in 40 patients with locally advanced or metastatic breast cancer.
- Trial name
- NCT05021900
- Testing
- Tenalisib 800mg, Tenalisib 1200mg
- Where
- 3 sites in Georgia
- Volunteers
- 40 people
- Sponsor
- Rhizen Pharmaceuticals SA
Breast Cancer
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer
This is a first-in-human, Phase Ia/Ib, dose-escalation and expansion study evaluating the safety, pharmacokinetics, and activity of GDC-0587 (cyclin-dependent kinase-4 [CDK4] inhibitor) as a monotherapy and in combination with…
- Trial name
- NCT07214662
- Testing
- GDC-0587, Giredestrant, Omeprazole
- Where
- 4 sites in United States, Taiwan
- Volunteers
- 3 people
- Sponsor
- Genentech, Inc.
Triple Negative Breast Cancer
Trilaciclib in Patients Receiving Sacituzumab Govitecan-hziy for Triple Negative Breast Cancer
This was a Phase 2, multicenter, open-label, single-arm study evaluating the safety and efficacy of trilaciclib administered prior to sacituzumab govitecan-hziy in participants with unresectable, locally advanced or metastatic…
- Trial name
- NCT05113966
- Testing
- Trilaciclib, Sacituzumab Govitecan-hziy
- Where
- 22 sites in United States
- Volunteers
- 30 people
- Sponsor
- G1 Therapeutics, Inc.
HER2-positive Breast Cancer, Metastatic Breast Cancer
SMP-656 for HER2-Positive Advanced Breast Cancer
The goal of this clinical trial is to learn if single-agent SMP-656 works to treat patients with HER2-positive locally advanced or metastatic breast cancer who have progressed after prior HER2-targeted topoisomerase inhibitor…
- Conditions
- HER2-positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC)
- Trial name
- NCT07726342
- Testing
- SMP-656 Injection
- Where
- 15 sites in China
- Volunteers
- 60 people
- Sponsor
- Chengdu SciMount Pharmatech Co., Ltd.
TNBC
A Study of HB0025 Plus Nab-paclitaxel as First Line Therapy for TNBC
This trial is a Phase II study. The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of HB0025 administered with chemotherapy in participants with locally advanced or metastatic triple-negative…
- Trial name
- NCT07376629
- Testing
- HB0025 20 mg/kg plus nab-paclitaxel, HB0025 10 mg/kg plus nab-paclitaxel
- Where
- 23 sites in China
- Volunteers
- 60 people
- Sponsor
- Huabo Biopharm Co., Ltd.
Triple Negative Breast Cancer
FDA018-ADC vs Investigator's Choice Chemotherapy to Treat Locally Advanced, Recurrent or Metastatic Triple-negative Breast Cancer
This is a Phase III, randomized, open-label, 2-arm, multicentre, international study assessing the efficacy and safety of FDA018-ADC compared with Investigator's Choice Chemotherapy(ICC) in participants with locally recurrent…
- Trial name
- NCT06519370
- Testing
- FDA018-ADC, Eribulin, Capecitabine
- Where
- China
- Volunteers
- 350 people
- Sponsor
- Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
Neoplasm Malignant, Renal Cell Carcinoma
A Study of XL092 as Single-Agent and Combination Therapy in Subjects With Solid Tumors
This is a Phase 1, open-label, dose-escalation and expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect on biomarkers of XL092 administered alone, in combination…
- Conditions
- Neoplasm Malignant, Renal Cell Carcinoma, Hormone Receptor Positive Breast Carcinoma, Metastatic Castration-resistant Prostate Cancer
- Trial name
- STELLAR-001 (NCT03845166)
- Testing
- XL092, Atezolizumab, Avelumab
- Where
- 86 sites in United States, Australia and 8 more
- Volunteers
- 325 people
- Sponsor
- Exelixis
Breast Cancer
Phase III Trial Comparing Capecitabine in Combination With Sorafenib or Placebo in the Treatment of Locally Advanced or Metastatic HER2-Negative Breast Cancer
The objective of this phase-III trial is to compare the efficacy and safety of sorafenib in combination with capecitabine versus capecitabine in combination with placebo in the treatment of subjects with locally advanced or…
- Trial name
- NCT01234337
- Testing
- Sorafenib (Nexavar, BAY43-9006), Capecitabine
- Where
- 153 sites in United States, Argentina and 21 more
- Volunteers
- 537 people
- Sponsor
- Bayer
Breast Cancer
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
The purpose of this study is to learn about the safety and effects of the study medicine PF-07248144 when given along with fulvestrant for the possible treatment of HR-positive, HER2-negative advanced or metastatic breast cancer.
- Trial name
- NCT07062965
- Testing
- PF-07248144, Fulvestrant, Everolimus
- Where
- 433 sites in United States, Argentina and 29 more
- Volunteers
- 400 people
- Sponsor
- Pfizer
Postmenopausal Women, Locally Advanced Metastatic Breast Cancer
Safety and Efficacy of RAD001 (Everolimus) in Combination With Letrozole in the Treatment of Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
This was a multi-center, Israeli phase II open label study evaluating treatment with RAD001 (10 mg daily) combined with letrozole (2.5 mg daily) in postmenopausal women after recurrence or progression on Tamoxifen, Anastrozole or…
- Conditions
- Postmenopausal Women, Locally Advanced Metastatic Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT01231659
- Testing
- Everolimus, Letrozole
- Where
- 7 sites in Israel
- Volunteers
- 72 people
- Sponsor
- Novartis Pharmaceuticals
Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma, Pancreatic Adenocarcinoma
A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors
This study will help find the most suitable dose of ASP546C in people with gastric cancer, gastroesophageal junction (GEJ) cancer, pancreatic cancer, and other specific solid tumors.
- Trial name
- NCT07488676
- Testing
- ASP546C
- Where
- 21 sites in United States, Japan
- Volunteers
- 150 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Metastatic Breast Cancer
A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus the Combination of Trastuzumab Plus Docetaxel in Patients With HER2-positive Breast Cancer
This is a Phase III, randomized, multicenter, multinational, two-arm, open-label clinical trial to investigate a first-line treatment of participants with human epidermal growth factor receptor-2 (HER2)-positive metastatic breast…
- Trial name
- NCT02144012
- Testing
- Trastuzumab, Trastuzumab Emtansine, Docetaxel
- Where
- 8 sites in Malaysia, South Korea and 2 more
- Volunteers
- 49 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer
A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer
The aim of this study is to evaluate the efficacy and safety of ESG401 in patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer.
- Trial name
- NCT06383767
- Testing
- ESG401, Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice)
- Where
- China
- Volunteers
- 378 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Breast Cancer
Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer
The objective of this non-interventional study (NIS) is to evaluate prevalence of ESR1 mutation after endocrine therapy in the palliative setting, quality of life, tolerability, and safety and to describe treatment detail and…
- Trial name
- ELENI (NCT07563595)
- Testing
- Elacestrant, Standard of care (Investigator Choice)
- Where
- 3 sites in Germany
- Volunteers
- 500 people
- Sponsor
- iOMEDICO AG