Clinical trials: Metastatic or Locally Advanced Breast Cancer
Breast Cancer
Phase I Study to Evaluate SIM0270 Alone or in Combination in ER+, HER2- Locally Advanced or Metastatic Breast Cancer
This study is a multi-center, open-label, Phase 1 clinical study to evaluate the safety, pharmacokinetic (PK) and anti-tumor efficacy of SIM0270 and SIM0270 in combination with palbociclib or everolimus in subjects with estrogen…
- Trial name
- NCT05293964
- Testing
- SIM0270, Palbociclib, everolimus
- Where
- China
- Volunteers
- 214 people
- Sponsor
- Jiangsu Simcere Pharmaceutical Co., Ltd.
Triple-Negative Breast Cancer
A Study of Ipatasertib in Combination With Atezolizumab and Paclitaxel as a Treatment for Participants With Locally Advanced or Metastatic Triple-Negative Breast Cancer
This study evaluated the efficacy and safety of ipatasertib in combination with atezolizumab and paclitaxel in locally advanced or metastatic Triple-Negative Breast Cancer (TNBC) previously untreated in this setting.
- Trial name
- NCT04177108
- Testing
- Atezolizumab, Ipatasertib, Paclitaxel
- Where
- 182 sites in United States, Argentina and 35 more
- Volunteers
- 242 people
- Sponsor
- Hoffmann-La Roche
Triple-negative Breast Cancer and HR+/HER2- BC
SKB264 +/- KL-A167 in Recurrent or Metastatic HER2-negative Breast Cancer
The purpose of this study is to assess the safety and tolerability and preliminary antitumor activity of SKB264 with/without KL-A167 in patients with unresectable locally advanced, recurrent or metastatic TNBC and HR+/HER2- BC…
- Trial name
- NCT05445908
- Testing
- SKB264, KL-A167
- Where
- 2 sites in China
- Volunteers
- 184 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Metastatic Breast Cancer, Breast Cancer
A Study of Pembrolizumab and Ablation (Cryoablation or Histotripsy) in People With Breast Cancer
Participants will have a confirmed diagnosis of metastatic breast cancer and will receive pembrolizumab in combination with ablation (cryoablation or histotripsy) OR pembrolizumab alone. Participants will be randomly assigned.
- Conditions
- Metastatic Breast Cancer, Breast Cancer, Breast Cancer Stage IV, Triple Negative Breast Cancer
- Trial name
- NCT06246968
- Testing
- Pembrolizumab, Cryoablation, Histotripsy
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Metastatic Breast Cancer
Study of Palbociclib and Trastuzumab With Endocrine Therapy in HER2-positive Metastatic Breast Cancer
PATRICIA is a phase II, open-label, multicentre, Simon's two-stage-design study of the combination of palbociclib plus trastuzumab, with or without letrozole, in post-menopausal patients with HER2-positive locally advanced or…
- Trial name
- PATRICIA II (NCT02448420)
- Testing
- Palbociclib, Trastuzumab, Endocrine therapy
- Where
- 35 sites in Spain
- Volunteers
- 73 people
- Sponsor
- SOLTI Breast Cancer Research Group
Breast Neoplasms
A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01)
The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload versus treatment of physician's choice (TPC)…
- Trial name
- NCT06926868
- Testing
- Iza-bren, Nab-paclitaxel, Paclitaxel
- Where
- 295 sites in United States, Argentina and 26 more
- Volunteers
- 600 people
- Sponsor
- Bristol-Myers Squibb
Breast Neoplasms
A Study of LY3484356 in Chinese Participants With Advanced Breast Cancer
This is a study of LY3484356 in Chinese participants with advanced breast cancer. Participants must have breast cancer that is estrogen receptor positive (ER+), HER2 negative (HER2-).
- Trial name
- NCT05509790
- Testing
- LY3484356
- Where
- 4 sites in China
- Volunteers
- 17 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus…
- Trial name
- NCT01120184
- Testing
- docetaxel, paclitaxel, pertuzumab
- Where
- 257 sites in United States, Argentina and 36 more
- Volunteers
- 1,095 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Human Epidermal Growth Factor Receptor 2 (HER2) Positive Unresectable Locally Advanced or Metastatic Breast Cancer Disease Registry Study
This disease registry is a prospective, multicenter non-interventional study designed to observe the different anticancer treatment regimens and their sequencing throughout the course of the disease in participants with…
- Trial name
- ESTHER (NCT02393924)
- Testing
- No intervention
- Where
- 30 sites in United Kingdom
- Volunteers
- 311 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study of A166 in Patients With Advanced Solid Malignant Tumors
This is a single arm, open-label, dose-escalation and dose-expansion phase I study evaluating A166 in patients with HER2-expressing locally advanced or metastatic solid tumors.
- Trial name
- NCT05311397
- Testing
- A166
- Where
- China
- Volunteers
- 129 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Breast Cancer
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
HS-10352 is a highly potent and selective small molecule inhibitor of phosphoinositide 3-kinase (p110α). In preclinical studies, it demonstrated strong activity against PI3K p110α in vitro and in vivo, and inhibited tumor cell…
- Trial name
- NCT04631835
- Testing
- HS-10352
- Where
- 3 sites in China
- Volunteers
- 54 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Breast Neoplasms
Phase 3 Study of LY353381 Vs Tamoxifen in Women With Locally Advanced or Metastatic Breast Cancer.
To determine the safety and efficacy of LY353381 when compared to tamoxifen in women with advanced or metastatic breast cancer.
- Trial name
- NCT00034125
- Testing
- LY353381, tamoxifen
- Where
- 11 sites in United States, Argentina and 3 more
- Sponsor
- Eli Lilly and Company
Breast Cancer
STRIDE - STimulating Immune Response In aDvanced brEast Cancer
EMD Serono has decided to permanently terminate the trial EMR 200038-010 (STRIDE) in the indication of breast cancer following the clinical hold on the investigational new drug application for tecemotide (L-BLP25).
- Trial name
- STRIDE (NCT00925548)
- Testing
- Tecemotide (L-BLP25) and Hormonal Treatment, cyclophosphamide, sodium chloride (NaCl)
- Where
- 29 sites in United States, Australia and 10 more
- Volunteers
- 16 people
- Sponsor
- EMD Serono
Breast Adenocarcinoma, Metastatic Triple-Negative Breast Carcinoma
Pembrolizumab and Binimetinib in Treating Patients With Locally Advanced or Metastatic Triple Negative Breast Cancer
This phase I/II trial studies the best dose of pembrolizumab and binimetinib and how well it works when given together with pembrolizumab in treating patients with triple negative breast cancer that has spread to other parts of…
- Conditions
- Breast Adenocarcinoma, Metastatic Triple-Negative Breast Carcinoma, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7
- Trial name
- NCT03106415
- Testing
- Binimetinib, Laboratory Biomarker Analysis, Pembrolizumab
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Mayo Clinic
Cancer, Sarcoma
EBNK-001 Allogeneic NK Cells With Low-Dose IL-15 ± Pembrolizumab in Advanced Solid Tumors
This Phase 1/2 study evaluates the safety, tolerability, and preliminary anti-tumor activity of EBNK-001 (allogeneic NK cells) given after lymphodepleting cyclophosphamide/fludarabine (CY/FLU) and supported with low-dose IL-15…
- Conditions
- Cancer, Sarcoma, Leukaemia, Breast Cancer (Locally Advanced or Metastatic)
- Trial name
- EBNK-ST-001 (NCT07410676)
- Testing
- EBNK-001 + IL-15 + Pembrolizumab
- Where
- China
- Volunteers
- 83 people
- Sponsor
- Essen Biotech
Advance Solid Tumors
A Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors
This is a 2-part, first-in-human, open-label study to determine the safety and tolerability of KIVU-107, a PTK7-directed antibody-drug conjugate, in participants with locally advanced or metastatic solid tumors.
- Trial name
- NCT07229313
- Testing
- KIVU-107
- Where
- 7 sites in United States, Australia
- Volunteers
- 76 people
- Sponsor
- Kivu Bioscience Inc.
HER2 + Breast Cancer
A Phase II Study of HLX22 in Combination With Trastuzumab and Chemotherapy in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients
This is a phase II study of HLX22 in combination with trastuzumab and chemotherapy versus placebo in combination with trastuzumab and chemotherapy in locally advanced and/or metastatic HER2-Positive breast cancer previously…
- Trial name
- NCT07824869
- Testing
- HLX22, Trastuzumab, Capecitabine
- Volunteers
- 90 people
- Sponsor
- Shanghai Henlius Biotech
Metastatic Breast Cancer, Breast Cancer
Fulvestrant and EVerolimus Plus EXemestane in Metastatic Breast Cancer
This is a multi-center, randomized, open-label, parallel group study designed to evaluate efficacy and safety of fulvestrant followed, at progression, by examestane and everolimus versus examestane and everolimus followed, at…
- Conditions
- Metastatic Breast Cancer, Breast Cancer, Hormone Receptor Positive Tumor, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Trial name
- FEVEX (NCT02404051)
- Testing
- Everolimus, Exemestane, Fulvestrant
- Where
- 41 sites in Italy
- Volunteers
- 745 people
- Sponsor
- Consorzio Oncotech
Unrespectable Locally Advanced and or Metastatic HER2 Positive Breast Cancer Participants
JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer
This study is designed to compare the safety and efficacy of JSKN003 versus T-DM1 in unrespectable locally advanced and/or metastatic HER2-positive breast cancer participants previously treated with trastuzumab and taxane.
- Trial name
- NCT06846437
- Testing
- JSKN003, Trastuzumab emtansine (T-DM1)
- Where
- China
- Volunteers
- 228 people
- Sponsor
- Shanghai JMT-Bio Inc.
Imaging, Colorectal Cancer
A Phase 1, Multicenter Imaging Study of LNTH-2403 in Participants With Locally Advanced or Metastatic Solid Tumors.
LNTH-2403 (177Lu-DOTA-DUNP19) is a lutetium-177 radiolabeled, fully humanized monoclonal antibody (mAb) that binds with high specificity and affinity to leucine-rich repeat containing 15 (LRRC15), a transforming growth factor…
- Conditions
- Imaging, Colorectal Cancer, Head and Neck Squamous Cell Carcinoma, Non-Small Cell Lung Cancer
- Trial name
- DUNP19 (NCT07272642)
- Testing
- LNTH-2403
- Where
- Australia
- Volunteers
- 16 people
- Sponsor
- Radiopharm Theranostics, Ltd