Clinical trials: Advanced Unresectable or Metastatic Breast Cancer
- Condition Advanced Unresectable or Metastatic Breast Cancer
- Funder type Industry (pharma, biotech, devices)
Metastatic Breast Cancer, Locally Advanced Breast Cancer
A Study of Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable locally advanced breast cancer…
- Trial name
- NCT02595762
- Where
- 12 sites in Cyprus, Greece
- Volunteers
- 110 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer, Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer
Tucatinib+Trastuzumab+Eribulin in HER2+ MBC
The purpose of this study is to evaluate the safety and efficacy of the three-drug combination of tucatinib, trastuzumab, and eribulin in patients with de novo and recurrent unresectable metastatic HER-2/neu positive breast…
- Trial name
- NCT05458674
- Testing
- Tucatinib, Eribulin, Trastuzumab
- Where
- 6 sites in United States
- Volunteers
- 17 people
- Sponsor
- Criterium, Inc.
HER2-positive Breast Cancer, HER2-low Breast Cancer
A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH)
This multi-center observational prospective study will collect real-world clinical and patient-reported outcome data from eligible patients with unresectable or metastatic HER2+ breast cancer who have received one or more prior…
- Conditions
- HER2-positive Breast Cancer, HER2-low Breast Cancer, Breast Cancer, Advanced Cancer
- Trial name
- NCT06210776
- Testing
- Trastuzumab deruxtecan
- Where
- 54 sites in China
- Volunteers
- 800 people
- Sponsor
- Daiichi Sankyo
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
Triple Negative Breast Neoplasms
Safety and Efficacy of SGN-LIV1A Plus Pembrolizumab for Patients With Locally-Advanced or Metastatic Triple-Negative Breast Cancer
This trial studies ladiratuzumab vedotin (LV) with pembrolizumab in patients with triple-negative breast cancer. It will find out what side effects happen when participants get these two drugs.
- Trial name
- NCT03310957
- Testing
- ladiratuzumab vedotin, Pembrolizumab
- Where
- 50 sites in United States, Germany and 2 more
- Volunteers
- 185 people
- Sponsor
- Seagen Inc.
Advanced Solid Tumors, HER2 Mutation
A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Researchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety…
- Trial name
- panSOHO (NCT06760819)
- Testing
- BAY2927088
- Where
- 54 sites in United States, Australia and 9 more
- Volunteers
- 111 people
- Sponsor
- Bayer
HER2-positive Breast Cancer
A Study of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer
This study is a phase II clinical trial to evaluate the safety and efficacy of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel as first-line treatment in patients with unresectable locally advanced or metastatic…
- Trial name
- NCT06445400
- Testing
- BL-M07D1, Pertuzumab, Docetaxel
- Where
- China
- Volunteers
- 83 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
A Safety and Activity Study of SBT6050 in Combination With Other HER2-directed Therapies for HER2-positive Cancers
This study is designed to assess the safety and preliminary activity of SBT6050 in combination with trastuzumab deruxtecan (Part 1) or tucatinib plus trastuzumab +/- capecitabine (Part 2).
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Colorectal Cancer, HER2-expressing Non-small Cell Lung Cancer
- Trial name
- NCT05091528
- Testing
- SBT6050, trastuzumab deruxtecan, tucatinib
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Silverback Therapeutics
Breast Cancer
FS-1502 Versus T-DM1 for HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
This study is designed to compare the anti-tumor activity as well as the safety and efficacy of FS-1502 versus T-DM1 in HER2-positive, unresectable locally advanced or metastatic breast cancer subjects previously treated with…
- Trial name
- NCT05755048
- Testing
- Investigational drug: Recombinant Anti-HER2 Humanized Monoclonal Antibody - Monomethyl Auristatin F Conjugates for Injection (FS-1502), Control drug: Trastuzumab emtansine (Kadcyla, T-DM1)
- Where
- 56 sites in China
- Volunteers
- 314 people
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Locally Advanced or Metastatic Breast Cancer
YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer
The study will evaluate the safety and efficacy of YL202, when compared with treatment of physician's choice (eribulin, capecitabine, vinorelbine, gemcitabine or sacituzumab govitecan) in participants with unresectable locally…
- Trial name
- NCT07461454
- Testing
- YL202, Eribulin, Capecitabine
- Where
- China
- Volunteers
- 376 people
- Sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
TNBC
A Study of PM8002 Plus Nab-paclitaxel as First Line Therapy for TNBC
Here, the investigators present the results from a Phase Ib/II study of PM8002 in combination with nab-paclitaxel in subjects with locally advanced or metastatic triple negative breast cancer without previous systematic treatment.
- Trial name
- NCT05918133
- Testing
- PM8002, nab-paclitaxel
- Where
- 8 sites in China
- Volunteers
- 42 people
- Sponsor
- Biotheus Inc.
Metastatic Breast Cancer
SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is superior to physician's choice in prolonging progression free survival.
- Trial name
- TULIP (NCT03262935)
- Testing
- (vic-)trastuzumab duocarmazine, Physician's choice
- Where
- 90 sites in United States, Belgium and 9 more
- Volunteers
- 437 people
- Sponsor
- Byondis B.V.
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.
Breast Cancer
Safety and Pharmacokinetic Study of MM-302 in Patients With Advanced Breast Cancer
This study is a Phase 1 and pharmacologic open-label dose-escalation trial using a "3+3" design. Successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified.
- Trial name
- NCT01304797
- Testing
- MM-302 Monotherapy, MM-302 in combination with trastuzumab, MM-302 in combination with trastuzumab q3w
- Where
- 5 sites in United States
- Volunteers
- 75 people
- Sponsor
- Merrimack Pharmaceuticals
Advanced Breast Cancer, Metastatic Breast Cancer
A Study of MRG002 in the Treatment of Patients With HER2-positive Unresectable Locally Advanced or Metastatic Breast Cancer
The primary objective of Phase II is to evaluate the safety, efficacy, pharmacokinetics, and immunogenicity of MRG002 in patients with HER2-positive, unresectable locally advanced or metastatic breast cancer.
- Trial name
- NCT04924699
- Testing
- MRG002, Trastuzumab Emtansine for Injection
- Where
- 19 sites in China
- Volunteers
- 350 people
- Sponsor
- Shanghai Miracogen Inc.
Metastatic Breast Cancer, HER2-negative Breast Cancer
Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.
Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.
- Conditions
- Metastatic Breast Cancer, HER2-negative Breast Cancer, ER+ Breast Cancer, Advanced Breast Cancer
- Trial name
- TRACY-1 (NCT06590857)
- Testing
- RYZ101, Standard of Care Endocrine Therapy
- Where
- 31 sites in United States, Canada and 1 more
- Volunteers
- 64 people
- Sponsor
- RayzeBio, Inc.
Triple-Negative Breast Cancer (TNBC)
Combination Immunotherapy Treatment for Locally Advanced Unresectable or Metastatic, PD-L1 Negative (CPS<10), gBRCA Negative, Triple Negative Breast Cancer Including BreakVax ImmunoTreatment (Designed and Manufactured Per Patient), Chemotherapy and Anti PD-1 Therapy
The objective of this study is to evaluate the safety, feasibility, and preliminary antitumor activity of this multi-component immunotherapy strategy in patients with advanced solid tumors.
- Trial name
- NCT07762703
- Testing
- BreakVax, Ipilimumab 2.5 mg, Pembrolizumab
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- BreakBio Corp
Locally Advanced Non-resectable Breast Cancer, Metastatic Breast Cancer
Tesetaxel Every 3 Weeks vs Weekly vs Capecitabine as 1st-line Therapy for Locally Advanced or Metastatic Breast Cancer
This study is being conducted to compare the efficacy and safety of tesetaxel administered once every 3 weeks in a 21-day cycle, tesetaxel administered once weekly for 3 consecutive weeks in a 28-day cycle, and capecitabine…
- Trial name
- NCT01609127
- Testing
- Tesetaxel, Capecitabine
- Where
- United States
- Volunteers
- 213 people
- Sponsor
- Genta Incorporated
HER2 Positive Breast Cancer
A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer
This study is being done to see if tucatinib works better than placebo to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma.
- Trial name
- HER2CLIMB (NCT02614794)
- Testing
- tucatinib, capecitabine, trastuzumab
- Where
- 176 sites in United States, Australia and 13 more
- Volunteers
- 612 people
- Sponsor
- Seagen Inc.
Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations
This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless…
- Trial name
- DPT01 (NCT04639219)
- Testing
- Trastuzumab deruxtecan
- Where
- 30 sites in United States, Belgium and 7 more
- Volunteers
- 102 people
- Sponsor
- AstraZeneca