Clinical trials: HER2-Positive Breast Carcinoma
Early Breast Cancer
A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer
This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC)…
- Trial name
- FeDeriCa (NCT03493854)
- Testing
- Cyclophosphamide, Doxorubicin, Docetaxel
- Where
- 107 sites in United States, Argentina and 17 more
- Volunteers
- 500 people
- Sponsor
- Hoffmann-La Roche
Breast Neoplasms
Treatment Patterns and Clinical Outcomes Among Patients Receiving Palbociclib Combinations for Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2 ) Advanced/Metastatic Breast Cancer in the Arabian Gulf Region
retrospective non-interventional study (NIS) that aims to describe the demographics, clinical characteristics, clinical outcomes, and treatment patterns, among patients receiving palbociclib for the treatment of HR+/HER2…
- Trial name
- NCT04916509
- Testing
- Palbociclib plus an aromatase inhibitor, Palbociclib plus fulvestrant
- Where
- 7 sites in Qatar, Saudi Arabia and 1 more
- Volunteers
- 258 people
- Sponsor
- Pfizer
Breast Cancer, Gastric Cancer
A Combination Study of Kadcyla (Trastuzumab Emtansine) and Capecitabine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (mBC) or HER2-Positive Locally Advanced/Metastatic Gastric Cancer (LA/mGC)
This multicenter study will assess the maximum tolerated dose (MTD) of capecitabine in combination with Kadcyla (trastuzumab emtansine) in participants with HER2-positive mBC or HER2-positive LA/mGC using a Phase 1 design…
- Trial name
- TRAXHER2 (NCT01702558)
- Testing
- Capecitabine, Trastuzumab emtansine (T-DM1)
- Where
- 40 sites in Argentina, Brazil and 10 more
- Volunteers
- 182 people
- Sponsor
- Hoffmann-La Roche
Urothelial Carcinoma, Triple Negative Breast Cancer
A Safety and Preliminary Efficacy Study of SBT6290 Alone and in Combination With PD-(L)1 Inhibitors in Select Advanced Solid Tumors
This is a first-in-human, open-label, multicenter, dose-escalation and expansion study designed to investigate SBT6290 administered alone and in combination with pembrolizumab in advanced solid tumors associated with Nectin-4…
- Conditions
- Urothelial Carcinoma, Triple Negative Breast Cancer, Non-small Cell Lung Cancer, Squamous Cell Carcinoma of Head and Neck
- Trial name
- NCT05234606
- Testing
- SBT6290, pembrolizumab
- Sponsor
- Silverback Therapeutics
HR+ HER2- Breast Cancer
Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer
The study is a Phase 1b/2, multi-center, open-label, dose escalation trial evaluating the safety and preliminary efficacy of sapanisertib and serabelisib (PIKTOR) with fulvestrant and/or other anticancer therapies in participants…
- Trial name
- NCT07558733
- Testing
- Serabelisib, Sapanisertib, Fulvestrant
- Where
- 7 sites in United States
- Volunteers
- 32 people
- Sponsor
- Faeth Therapeutics
Breast Neoplasms, Invasive Breast Cancer
(Z)-Endoxifen for the Treatment of Premenopausal Women With ER+/HER2- Breast Cancer
This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer.
- Conditions
- Breast Neoplasms, Invasive Breast Cancer, Estrogen-receptor-positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- EVANGELINE (NCT05607004)
- Testing
- (Z)-endoxifen, goserelin
- Where
- 14 sites in United States
- Volunteers
- 87 people
- Sponsor
- Atossa Therapeutics, Inc.
Breast Neoplasms
A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]
The study is designed to compare the clinical benefit following treatment with letrozole in combination with Palbociclib versus letrozole in combination with placebo in Asian postmenopausal women with ER(+)/HER2(-) advanced…
- Trial name
- NCT02297438
- Testing
- Palbociclib, Letrozole
- Where
- 54 sites in China, Hong Kong and 3 more
- Volunteers
- 340 people
- Sponsor
- Pfizer
Metastatic Breast Cancer, Breast Cancer Stage I
A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
This is a Study to Evaluate the Efficacy and Safety of Multiple Combination Therapies with FWD1802 in Subjects with ER-positive/HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Locally Advanced Breast Cancer (LABC)
- Trial name
- NCT07002177
- Testing
- FWD1802, Palbociclib 125mg, Ribociclib 200Mg Oral Tablet
- Where
- China
- Volunteers
- 196 people
- Sponsor
- Forward Pharmaceuticals Co., Ltd.
Breast Cancer
A Study of Trastuzumab Emtansine Versus Capecitabine + Lapatinib in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
This is a Phase III, randomized, multicenter, international, 2-arm, open-label clinical trial designed to compare the safety and efficacy of trastuzumab emtansine (T-DM1) with that of capecitabine + lapatinib in participants with…
- Trial name
- EMILIA (NCT00829166)
- Testing
- Trastuzumab emtansine, Lapatinib, Capecitabine
- Where
- 323 sites in United States, Bosnia and Herzegovina and 25 more
- Volunteers
- 991 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer
This trial is a randomized, open-label, multicenter Phase II study designed to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally recurrent or metastatic HR-positive, HER2-low expressing breast…
- Trial name
- NCT07678957
- Testing
- BL-M07D1, DS-8201
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Breast Neoplasms
Study of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus in Subjects With Bone Predominant HER2 Negative Hormone Receptor Positive Metastatic Breast Cancer
The objective of this study is to assess efficacy and safety of radium 223 dichloride in subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor positive breast cancer with bone metastases treated…
- Trial name
- NCT02258451
- Testing
- Radium-223 dichloride (Xofigo, BAY88-8223), Exemestane, Everolimus
- Where
- 92 sites in United States, Austria and 15 more
- Volunteers
- 283 people
- Sponsor
- Bayer
Locally Advanced or Metastatic Malignant Solid Tumors
A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR) per RECIST v1.1.
- Trial name
- NCT04225117
- Testing
- enfortumab vedotin, pembrolizumab
- Where
- 39 sites in United States, Canada and 1 more
- Volunteers
- 329 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Breast Cancer
A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer
This 3 arm study will assess the tolerability, safety and efficacy of 3 neoadjuvant treatment regimens in participants with locally advanced, inflammatory or early stage human epidermal growth factor receptor 2 (HER2)-positive…
- Trial name
- NCT00976989
- Testing
- Pertuzumab, Trastuzumab, FEC
- Where
- 55 sites in Bosnia and Herzegovina, Brazil and 18 more
- Volunteers
- 225 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer
Impact of 18F-FES PET on the Therapeutic Treatment of Patients With Metastatic Breast Cancer
This is a multi-center study in France to evaluate the impact of ESTROTEP PET/CT results on the therapeutic management of patients with metastatic breast cancer (MBC).
- Trial name
- ESTROTIMP (NCT05486182)
- Testing
- 18F Fluoroestradiol Radiopharmaceutical with PET/CT
- Where
- 11 sites in France
- Volunteers
- 153 people
- Sponsor
- GE Healthcare
Breast Cancer
Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia
This prospective, observational, multicenter study aims at evaluating the efficacy of adjuvant ribociclib in combination with hormone therapy (aromatase inhibitor ± GnRH aginost) in various subgroups of patients with HR+HER2…
- Trial name
- ELEGANCE (NCT06930859)
- Testing
- Ribociclib, Letrozole, Anastrozole
- Where
- 42 sites in Russia
- Volunteers
- 2,766 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Real-world Study Observing Treatment Patterns and Clinical Results for Patients in China With Hormone Receptor-positive, HER2-negative Metastatic Breast Cancer.
The study aims to describe demographics, clinical characteristics, genetic test diagnosis, treatment patterns, and clinical outcomes in HR+/HER2- (including HER2-low, HER2-ultralow, and HER2-null) unresectable or metastatic…
- Trial name
- VERITAS (NCT07743944)
- Where
- China
- Volunteers
- 2,000 people
- Sponsor
- AstraZeneca
Breast Cancer, Small Cell Lung Cancer
A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
This study is a first-in-human (FIH), Phase 1a/1b study of BG-68501, a cyclin-dependent kinase-2 inhibitor (CDK2i), to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary antitumor activity…
- Conditions
- Breast Cancer, Small Cell Lung Cancer, Ovarian Cancer, Gastric Cancer
- Trial name
- NCT06257264
- Testing
- BG-68501, Fulvestrant, BGB-43395
- Where
- 24 sites in United States, Australia and 4 more
- Volunteers
- 103 people
- Sponsor
- BeiGene
Breast Cancer
A Phase Ib Study of HS-10352 Plus Fulvestrant in Patients With Advanced Breast Cancer
HS-10352 is a highly potent and selective small molecule inhibitor of phosphoinositide 3-kinase (p110α). The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and efficacy of HS-10352 plus…
- Trial name
- NCT05504213
- Testing
- HS-10352 combined with fulvestrant (Stage 1), HS-10352 combined with fulvestrant (Stage 2)
- Where
- China
- Volunteers
- 224 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
A Study To Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
This observational disease registry is a prospective, national, non-interventional study designed to enroll participants who have received an initial diagnosis of unresectable, locally advanced (LA) or metastatic breast cancer…
- Trial name
- NCT02616224
- Testing
- No intervention
- Sponsor
- Hoffmann-La Roche
Breast Neoplasms, Breast Cancer
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer
This study will look at the efficacy and safety of trastuzumab deruxtecan (T-DXd) in a neoadjuvant setting, in high-risk, HER2-positive early non-metastatic breast cancer.
- Conditions
- Breast Neoplasms, Breast Cancer, HER2-positive Early Breast Cancer
- Trial name
- NCT05113251
- Testing
- Trastuzumab Deruxtecan, Paclitaxel, Trastuzumab
- Where
- 145 sites in United States, Brazil and 16 more
- Volunteers
- 927 people
- Sponsor
- AstraZeneca