Clinical trials: HER2 Positive Metastatic Breast Cancer
Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer
PUMA-ALI-1201 is a randomized, dose optimization, multicenter, Phase 2 study of alisertib administered in combination with endocrine therapy in participants with pathology-confirmed HR-positive/HER2-negative metastatic breast…
- Conditions
- Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Trial name
- ALISCA-Breast1 (NCT06369285)
- Testing
- Alisertib, Endocrine therapy
- Where
- 53 sites in United States, Portugal and 1 more
- Volunteers
- 225 people
- Sponsor
- Puma Biotechnology, Inc.
Metastatic Breast Cancer
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in…
- Trial name
- NCT01942135
- Testing
- Palbociclib, Fulvestrant
- Where
- 247 sites in United States, Australia and 15 more
- Volunteers
- 521 people
- Sponsor
- Pfizer
Hormone Receptor Positive Breast Carcinoma, HER2-negative Breast Cancer
A Dose Escalation/Expansion Study of Oral OP-1250 in Subjects With Advanced and/or Metastatic HR+, HER2- Breast Cancer
This clinical trial is a Phase I dose escalation and dose expansion and Phase II monotherapy open-label, first-in-human, multicenter study of OP-1250 in adult subjects with advanced and/or metastatic hormone receptor…
- Trial name
- NCT04505826
- Testing
- OP-1250
- Where
- 19 sites in United States, Australia
- Volunteers
- 153 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Her 2 Positive Breast Cancer
A Study of A166 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer
Evaluation of the efficacy of A166 in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with TOP1 inhibitor Antibody-Drug Conjugates
- Trial name
- NCT07299825
- Testing
- A166
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.
Breast Cancer
Eribulin With Trastuzumab as First-line Therapy for Locally Recurrent or Metastatic HER2 Positive Breast Cancer
This is a multicenter phase 2 study designed to evaluate the safety and efficacy of eribulin mesylate in combination with trastuzumab as first line treatment in female subjects with locally recurrent or metastatic human epidermal…
- Trial name
- NCT01269346
- Testing
- Eribulin Mesylate
- Where
- 26 sites in United States
- Volunteers
- 52 people
- Sponsor
- Eisai Inc.
Advanced ER-Positive HER2-Negative Breast Cancer
A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer
This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.
- Trial name
- SERENA-2 (NCT04214288)
- Testing
- AZD9833, Fulvestrant
- Where
- 85 sites in United States, Belgium and 14 more
- Volunteers
- 240 people
- Sponsor
- AstraZeneca
Metastatic Breast Cancer
A Study to Observe Treatment Patterns and Outcomes in Participants in Saudi Arabia With Human Epidermal Growth Factor Receptor 2 (HER2-Positive) Unresectable Locally Advanced or Metastatic Breast Cancer (LA/mBC)
This is a prospective, national, multicenter, non-interventional study designed to enroll participants who have an initial diagnosis of unresectable LA/mBC made up to 6 months prior to registry enrollment.
- Trial name
- NCT02611310
- Testing
- No intervention
- Where
- 3 sites in Saudi Arabia
- Volunteers
- 15 people
- Sponsor
- Hoffmann-La Roche
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
Metastatic Breast Cancer
HER2-positive Metastatic Breast Cancer in Kazakhstan
Planned study population consists of approximately 240 adult patients with HER2-positive mBC receiving anti-HER2 therapy in 12 oncological centers (in each center it is expected to recruit about 20 patients) in different regions…
- Trial name
- NCT07593196
- Where
- 12 sites in Kazakhstan
- Volunteers
- 240 people
- Sponsor
- AstraZeneca
HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
A Trial of SHR-A1811versus Pyrotinib in Combination With Capecitabine in HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane
The study is being conducted to evaluate whether the efficacy of SHR-A1811 is better than Pyrotinib in combination with Capecitabine in HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With…
- Trial name
- NCT05424835
- Testing
- SHR-A1811, Pyrotinib in combination with Capecitabine.
- Where
- China
- Volunteers
- 381 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Recurrent or Metastatic Breast Cancer
A Phase III Study of SYS6010 Versus Chemotherapy in HER2-Negative, EGFR-Positive Recurrent or Metastatic Breast Cancer
This study is a multicenter, randomized, open-label, parallel-control Phase III clinical trial enrolling patients with unresectable HER2-negative, EGFR-positive recurrent/metastatic breast cancer who have previously failed first…
- Trial name
- NCT07406542
- Testing
- SYS6010, Investigator's Choice of Chemotherapy (eribulin, capecitabine, gemcitabine, or vinorelbine)
- Volunteers
- 400 people
- Sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
Breast Cancer
Study of Efficacy and Safety of Myl1401O + Taxane vs Herceptin©+ Taxane for 1st Line, Met. Br. Ca.
A multicenter, double-blind, randomized, parallel-group, Phase III study of the efficacy and safety of Hercules( Myl 1401O, Mylan Trastuzumab) plus taxane versus Herceptin® plus taxane as first line therapy in patients with…
- Trial name
- HERiTAge (NCT02472964)
- Testing
- Trastuzumab, MYL- 1401O, Paclitaxel
- Where
- 92 sites in Brazil, Chile and 13 more
- Volunteers
- 500 people
- Sponsor
- Mylan Inc.
Breast Cancer
A Study of Epothilone D in Combination With Herceptin (Trastuzumab) in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer
This single arm study will determine the efficacy and safety of an epothilone D and Herceptin combination regimen in patients with HER-2 positive locally advanced or metastatic breast cancer.
- Trial name
- NCT00337649
- Testing
- Epothilone D, Herceptin
- Where
- 6 sites in Spain
- Volunteers
- 27 people
- Sponsor
- Hoffmann-La Roche
Neoplasms, Breast
Neo ALTTO (Neoadjuvant Lapatinib and/or Trastuzumab Treatment Optimisation) Study
This is a randomised, open label multicenter Phase III study comparing the efficacy of neoadjuvant lapatinib plus paclitaxel, versus trastuzumab plus paclitaxel, versus concomitant lapatinib and trastuzumab plus paclitaxel given…
- Trial name
- Neo ALTTO (NCT00553358)
- Testing
- Lapatinib, Trastuzumab, Paclitaxel
- Where
- 121 sites in Argentina, Belgium and 22 more
- Volunteers
- 455 people
- Sponsor
- Novartis Pharmaceuticals
Breast Neoplasms, Breast Cancer
PROVIDENCE - Prospective Non-interventional Study (NIS) to Examine Patient-reported Outcomes and Real-world Clinical Data in Patients With HER2-positive, HER2-low or HER2-ultralow Unresectable or Metastatic Breast Cancer Treated With Trastuzumab Deruxtecan
This is a prospective non-interventional, multicenter study observing patient reported outcomes as well as real-world efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with documented Human epidermal growth factor…
- Conditions
- Breast Neoplasms, Breast Cancer, Neoplasm Metastasis
- Trial name
- PROVIDENCE (NCT05573893)
- Where
- 109 sites in Germany
- Volunteers
- 800 people
- Sponsor
- AstraZeneca
Advanced, Metastatic Breast Cancer
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer
The primary purpose of this study was to assess the efficacy of ribociclib, as measured by progression free survival (PFS), in postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2…
- Trial name
- MONALEESA-2 (NCT01958021)
- Testing
- Ribociclib, Letrozole
- Where
- 221 sites in United States, Argentina and 27 more
- Volunteers
- 668 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study to Assess Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in Participants With Metastatic or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer
This two-cohort, open-label, multicenter, phase 2 study will assess the safety and efficacy of pertuzumab given in combination with trastuzumab (Herceptin) and vinorelbine in first line participants with metastatic or locally…
- Trial name
- VELVET (NCT01565083)
- Testing
- Pertuzumab, Trastuzumab, Vinorelbine
- Where
- 80 sites in United States, Brazil and 5 more
- Volunteers
- 213 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A European Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced (LA) or Metastatic Breast Cancer (mBC) (SAMANTHA)
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 LA/mBC.
- Trial name
- NCT02913456
- Where
- 54 sites in Austria, Bulgaria and 3 more
- Volunteers
- 629 people
- Sponsor
- Hoffmann-La Roche
Neoplasms, Breast
A Phase II, Randomized, Open-label Study of Lapatinib Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy in HER2-positive and p95HER2-positive Metastatic Breast Cancer
This is a Phase II, randomized, open-label, multi-center study evaluating the efficacy and safety of lapatinib in combination with chemotherapy versus trastuzumab in combination with chemotherapy in women with HER2-positive and…
- Trial name
- NCT01137994
- Testing
- Lapatinib, Trastuzumab, Docetaxel
- Sponsor
- GlaxoSmithKline
Locally Advanced or Metastatic Breast Cancer
Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer
This study is designed to evaluate the safety and efficacy of SPH4336 combined with letrozole in first-line treatment of locally advanced or metastatic breast cancer
- Trial name
- NCT05744687
- Testing
- SPH4336 Tablets 400mg
- Where
- 9 sites in China
- Volunteers
- 374 people
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd