Clinical trials: Metastatic or Locally Advanced Breast Cancer
Cancer, Breast Cancer
Biomarker-Guided Allogeneic Single-Target or Dual-Target CAR-NK Cell Therapy for Advanced Solid Tumors
This Phase 1/2 study evaluates the safety, feasibility, and preliminary anti-tumor activity of allogeneic donor-derived CAR-NK cells in participants with advanced solid tumors.
- Conditions
- Cancer, Breast Cancer, Non-Small Cell Lung Cancer (NSCLC), Colorectal Cancer (Locally Advanced or Metastatic)
- Trial name
- SELECT-CAR-NK (NCT07410494)
- Testing
- EB-SELECT Single-Target CAR-NK Cells, Dual-Target Antigen-Selected CAR-NK
- Where
- China
- Volunteers
- 85 people
- Sponsor
- Essen Biotech
Breast Carcinoma
Phase II Study of AS1402 Combined With Letrozole to Treat Breast Cancer
The aim of this study is to compare the overall tumour response rate per RECIST in postmenopausal women with metastatic or locally advanced breast cancer receiving AS1402 in combination with letrozole compared to letrozole alone
- Trial name
- NCT00770354
- Testing
- AS1402, Letrozole
- Where
- 2 sites in Russia
- Volunteers
- 110 people
- Sponsor
- Antisoma Research
Metastatic Breast Cancer, Advanced Breast Cancer
Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer
This study aims to evaluate the efficacy and safety of U3-1402 in participants with advanced breast cancer (ABC). Participants have to be hormone-receptor positive (HR+) and have to be resistant to endocrine therapy and…
- Trial name
- ICARUS BREAST (NCT04965766)
- Testing
- U3-1402
- Where
- 11 sites in France
- Volunteers
- 139 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Breast Cancer
Study of SKB103 in HER2-negative Breast Cancer
This is a Phase I/II clinical study to evaluate the safety and efficacy of SKB103 in participants with advanced (locally advanced, recurrent, or metastatic) HER2-negative breast cancer.
- Trial name
- NCT07774624
- Testing
- SKB103 monotherapy
- Volunteers
- 140 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Premenopausal Breast Cancer, Metastatic Breast Cancer
Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC
This is an open-label randomized phase II study in estrogen receptor positive locally advanced or metastatic breast cancer patients.
- Conditions
- Premenopausal Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer
- Trial name
- NCT05720260
- Testing
- Goserelin, Fulvestrant, Capivasertib
- Where
- Taiwan
- Volunteers
- 42 people
- Sponsor
- National Taiwan University Hospital
Breast Cancer
Tesetaxel Plus Reduced Dose of Capecitabine vs. Capecitabine in HER2 Negative, HR Positive, LA/MBC
CONTESSA is a multinational, multicenter, randomized, Phase 3 study of tesetaxel in patients with HER2 negative, HR positive LA/MBC previously treated with a taxane in the neoadjuvant or adjuvant setting.
- Trial name
- CONTESSA (NCT03326674)
- Testing
- Tesetaxel and Capecitabine, Capecitabine
- Where
- 207 sites in United States, Australia and 17 more
- Volunteers
- 685 people
- Sponsor
- Odonate Therapeutics, Inc.
Breast Cancer, Real-world Study
A Real-world Study of Inetetamab for First-line Treatment of MBC
This is a prospective, multicenter, real-world study aimed at evaluating the efficacy and safety of inetetamab+chemotherapy or inetetamab+pyrotinib+chemotherapy or inetetamab+pertuzumab+chemotherapy in the treatment of HER2…
- Trial name
- NCT05980208
- Testing
- Inetetamab
- Volunteers
- 150 people
- Sponsor
- Hunan Cancer Hospital
Metastatic Breast Cancer, ER-positive Breast Cancer
Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer
This is a Phase 1b open-label, 2-part study in 4 treatment groups. The 4 treatment groups are as follows: Treatment Group 1: Palazestrant (OP-1250) in combination with ribociclib (KISQALI®, Novartis Pharmaceuticals Corporation).
- Conditions
- Metastatic Breast Cancer, ER-positive Breast Cancer, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- NCT05508906
- Testing
- Palazestrant, Ribociclib, Alpelisib
- Where
- 16 sites in United States, Australia
- Volunteers
- 190 people
- Sponsor
- Olema Pharmaceuticals, Inc.
HER2-positive, Unresectable, Locally Advanced or Metastatic Breast Cancer, SKB264
SKB264 Plus Inetetamab in HER2-Positive Metastatic Breast Cancer Patients Progressing After T-DXd Treatment
This is a prospective, single-arm, single-center, Phase II clinical study designed to assess the preliminary efficacy and safety of SKB264 Plus Inetetamab plus inetetamab for the treatment of HER2-positive, unresectable, locally…
- Conditions
- HER2-positive, Unresectable, Locally Advanced or Metastatic Breast Cancer, SKB264, Inetetamab
- Trial name
- SHINE-HER (NCT07182721)
- Testing
- SKB264 Plus Inetetamab
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Fudan 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, Progesterone Receptor Positive
Alisertib and Fulvestrant in Treating Patients With Hormone Receptor Positive Breast Cancer That is Metastatic or Locally Advanced and Cannot Be Removed by Surgery
This phase I trial studies the side effects and best dose of alisertib when given together with fulvestrant in treating patients with hormone positive breast cancer that has spread to other parts of the body or has spread from…
- Conditions
- Estrogen Receptor Positive, Progesterone Receptor Positive, Recurrent Breast Carcinoma, Stage IIIB Breast Cancer
- Trial name
- NCT02219789
- Testing
- Alisertib, Fulvestrant, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Mayo Clinic
Metastatic Breast Cancer
Capecitabine and Bevacizumab ± Vinorelbine in Metastatic Breast Cancer
The aim of the trial is to detect the superiority of the triple combination of capecitabine, bevacizumab and vinorelbine versus the combination of capecitabine and bevacizumab in patients with metastatic breast cancer.
- Trial name
- CARIN (NCT00868634)
- Testing
- capecitabine, bevacizumab, vinorelbine
- Where
- Germany
- Volunteers
- 600 people
- Sponsor
- iOMEDICO AG
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
Breast Cancer
T-DM1 in HER2-positive Metastatic/Relapsed Breast Cancer
This is a retrospective, multicenter, non-interventional study for the evaluation of real-world efficacy and safety of T-DM1 in metastatic/relapsed HER2-positive breast cancer as part of the establishment of hospital medical…
- Trial name
- NCT04202328
- Where
- 60 sites in South Korea
- Volunteers
- 1,000 people
- Sponsor
- Samsung Medical Center
Breast Neoplasms
PAlbociclib Plus Tamoxifen for the Treatment of Hormone Receptor-positive, HER2-negative Advanced Breast Cancer Women - Asian studY
This study is conducted to evaluate the benefit of adding palbociclib in hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer patients, regardless of menopausal status, treated with tamoxifen (with…
- Trial name
- PATHWAY (NCT03423199)
- Testing
- Palbociclib, Tamoxifen, Goserelin
- Where
- 23 sites in Japan, Singapore and 2 more
- Volunteers
- 180 people
- Sponsor
- National Cancer Center, Japan
Metastatic Breast Cancer
Phase I/II Study of MK-0752 Followed by Docetaxel in Advanced or Metastatic Breast Cancer
New and better therapies for locally advanced and metastatic breast cancer are needed because, even if standard treatment is successful in shrinking the cancer, there is still a high chance that the cancer will recur.
- Trial name
- NCT00645333
- Testing
- MK-0752, Docetaxel, Pegfilgrastim
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- University of Michigan Rogel Cancer Center
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.
Triple Negative Breast Cancer
the Role of Two Different Metronomic Chemotherapy Regimens in Locally Advanced or Metastatic Triple Negative Breast Cancer Patients (TNBC) as Maintenance Therapy After First Line Treatment
TNBC, defined by the lack of immunohistochemical staining for oestrogen receptors, progesterone receptors, and lack of overexpression or amplification of HER2/neu, has an aggressive biological behaviour, marked by increased risk…
- Trial name
- VICTOR3 (NCT03358004)
- Testing
- Vinorelbine Tartrate, Capecitabine 500 MG
- Where
- 30 sites in Italy, Portugal and 1 more
- Volunteers
- 4 people
- Sponsor
- Mario Negri Institute for Pharmacological Research