Clinical trials: HER 2 Positive Advanced Breast Cancer
Breast Cancer
Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer
The purpose of the study was to evaluate the safety and efficacy of a reduced ribociclib starting dose of 400 mg in combination with a non-steroidal aromatase inhibitor (NSAI) (letrozole or anastrozole) for the treatment of pre…
- Trial name
- AMALEE (NCT03822468)
- Testing
- Ribociclib, Anastrozole, Letrozole
- Where
- 89 sites in United States, Argentina and 21 more
- Volunteers
- 376 people
- Sponsor
- Novartis Pharmaceuticals
HER2-positive, Adenocarcinoma
CAR-macrophages for the Treatment of HER2 Overexpressing Solid Tumors
Phase 1, first-in-human, open label study of CAR macrophages in HER2 overexpressing solid tumors.
- Conditions
- HER2-positive, Adenocarcinoma, Bile Duct Cancer, Biliary Tract Cancer
- Trial name
- NCT04660929
- Testing
- CT-0508, Pembrolizumab
- Where
- 7 sites in United States
- Volunteers
- 48 people
- Sponsor
- Carisma Therapeutics Inc
Locally Advanced or Unresectable Metastatic Breast Cancer, Stage IV Breast Cancer
Study of Sacituzumab Govitecan Versus Treatment of Physician's Choice in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Metastatic Breast Cancer Who Have Received Endocrine Therapy
The goal of this clinical study is to see if sacituzumab govitecan-hziy (SG) can improve life spans of people with HR+/HER2- metastatic breast cancer and their tumor does not grow or spread when compared to currently available…
- Trial name
- ASCENT-07 (NCT05840211)
- Testing
- Sacituzumab Govitecan-hziy, Paclitaxel, Nab-paclitaxel
- Where
- 288 sites in United States, Argentina and 26 more
- Volunteers
- 654 people
- Sponsor
- Gilead Sciences
Breast Cancer
A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of pyrotinib in women with early stage high-risk breast cancer after adjuvant trastuzumab.
- Trial name
- NCT03980054
- Testing
- Pyrotinib
- Where
- China
- Volunteers
- 2,135 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer
A Study of Herceptin (Trastuzumab) in Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Advanced and/or Metastatic Breast Cancer
This study will assess the efficacy and safety of intravenous (IV) trastuzumab (Herceptin) and IV docetaxel (Taxotere), with or without oral capecitabine (Xeloda), in women with previously untreated HER2-positive advanced and/or…
- Trial name
- NCT02748213
- Testing
- Xeloda, Taxotere, Herceptin
- Where
- 51 sites in Australia, Brazil and 13 more
- Volunteers
- 225 people
- Sponsor
- Hoffmann-La Roche
Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting
This was a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation…
- Trial name
- NCT04967248
- Testing
- Alpelisib, Fulvestrant
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Metastasis
Study of Dasatinib (BMS-354825) in Patients With Advanced Estrogen/Progesterone Receptor-positive (ER+/PR+) or Her2/Neu-positive (Her2/Neu+)Breast Cancer
This study will determine whether the investigational drug dasatinib is effective in treatment of women with progressive advanced ER+/PR+ or Her2/neu+ breast cancer
- Trial name
- NCT00371345
- Testing
- Dasatinib, Dasatinib 100 mg
- Where
- 23 sites in United States, Argentina and 5 more
- Volunteers
- 92 people
- Sponsor
- Bristol-Myers Squibb
Breast Cancer
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-0587 as a Monotherapy and in Combination With Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer
This is a first-in-human, Phase Ia/Ib, dose-escalation and expansion study evaluating the safety, pharmacokinetics, and activity of GDC-0587 (cyclin-dependent kinase-4 [CDK4] inhibitor) as a monotherapy and in combination with…
- Trial name
- NCT07214662
- Testing
- GDC-0587, Giredestrant, Omeprazole
- Where
- 4 sites in United States, Taiwan
- Volunteers
- 3 people
- Sponsor
- Genentech, 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.
Breast Cancer, HER2 Positive Breast Cancer
Efficacy and Safety of IPI-504 With Trastuzumab Pretreated, Locally Advanced or Metastatic HER2 Positive Breast Cancer
The purpose of this study is to see if IPI-504 in combination with trastuzamab is an effective treatment in HER2 positive metastatic breast cancer
- Conditions
- Breast Cancer, HER2 Positive Breast Cancer, Metastatic Breast Cancer, Cancer of the Breast
- Trial name
- NCT00817362
- Testing
- IPI-504, Trastuzumab
- Where
- 11 sites in United States, Spain
- Volunteers
- 29 people
- Sponsor
- Infinity Pharmaceuticals, Inc.
Advanced Breast Cancer
Open-label, Phase II Study of Stomatitis Prevention With a Steroid-based Mouthwash in Post-menopausal Women With Estrogen-receptor-positive (ER+), Human Epidermal Growth Factor Receptor 2 (HER2)- Metastatic or Locally Advanced Breast Cancer
Open-label, Phase II study of Stomatitis prevention with a steroid-based mouthwash in Post-menopausal women with ER+, HER2- Metastatic or Locally Advanced Breast Cancer
- Trial name
- NCT02069093
- Testing
- Dexamethasone based mouthwash, Everolimus, Exemestane
- Where
- 23 sites in United States
- Volunteers
- 92 people
- Sponsor
- Novartis Pharmaceuticals
Neoplasms
Dose Escalation and Expansion Study of GSK525762 in Combination With Fulvestrant in Participants With Hormone Receptor-positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Advanced or Metastatic Breast Cancer
This is a combination Phase I and Phase II study, with an aim to evaluate the combination of GSK525762 and fulvestrant in women with HR+/HER2- advanced or metastatic breast cancer, who have disease that has progressed after prior…
- Trial name
- NCT02964507
- Testing
- GSK525762, Fulvestrant
- Where
- 38 sites in United States, Australia and 5 more
- Volunteers
- 124 people
- Sponsor
- GlaxoSmithKline
Metastatic Breast Cancer
A Study of Abemaciclib (LY2835219) in Participants With HR+, HER2- Advanced Breast Cancer
The reason for this study is to see if the drug abemaciclib in combination with nonsteroidal aromatase inhibitors (anastrozole or letrozole) is effective in participants with Hormone Receptor Positive (HR+), Human Epidermal…
- Trial name
- proMONARCH (NCT03988114)
- Testing
- Abemaciclib, Nonsteroidal Aromatase Inhibitor (NSAI)
- Where
- 119 sites in United States, Argentina and 7 more
- Sponsor
- Eli Lilly and Company
Breast Cancer
A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment.
The purpose of this study is to learn about the safety and effects of the study medicine PF-07248144 when given along with fulvestrant for the possible treatment of HR-positive, HER2-negative advanced or metastatic breast cancer.
- Trial name
- NCT07062965
- Testing
- PF-07248144, Fulvestrant, Everolimus
- Where
- 433 sites in United States, Argentina and 29 more
- Volunteers
- 400 people
- Sponsor
- Pfizer
HER2-positive Breast Cancer, HER-2 Protein Overexpression
Study of ORM-5029 in Subjects With HER2-Expressing Advanced Solid Tumors
This is a Phase 1 first-in-human study of ORM-5029 in participants with HER2-expressing advanced solid tumors. The study consists of two parts: a Part 1 Dose Escalation and Part 2 Dose Expansion.
- Conditions
- HER2-positive Breast Cancer, HER-2 Protein Overexpression, HER-2 Gene Amplification, HER2 Gene Mutation
- Trial name
- NCT05511844
- Testing
- ORM-5029
- Where
- 11 sites in United States
- Volunteers
- 25 people
- Sponsor
- Orum Therapeutics USA, Inc.
HER2 Amplified, Advanced Breast Cancer
A Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2 Positive (HER2+), Androgen Receptor Positive (AR+) Metastatic or Locally Advanced Breast Cancer
The purpose of this study was to evaluate the efficacy of enzalutamide with trastuzumab in patients with HER2+ AR+ metastatic or locally advanced breast cancer.
- Conditions
- HER2 Amplified, Advanced Breast Cancer, Human Epidermal Growth Factor Receptor 2 (HER2)
- Trial name
- NCT02091960
- Testing
- Enzalutamide, Trastuzumab
- Where
- 39 sites in United States, Belgium and 4 more
- Volunteers
- 103 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Advanced Breast Cancer
Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer
A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a…
- Trial name
- SERENA-1b (NCT07427394)
- Testing
- Camizestrant, Atirmociclib
- Where
- 6 sites in United States, United Kingdom
- Volunteers
- 24 people
- Sponsor
- AstraZeneca
Advanced Estrogen Receptor Positive HER2- Breast Cancer
GS-5829 in Combination With Fulvestrant or Exemestane in Women With Advanced Estrogen Receptor Positive, HER2 Negative-Breast Cancer
The primary objectives of the Phase 1b Dose Escalation part of this study are to characterize the safety and tolerability of GS-5829 in combination with exemestane or fulvestrant and to determine the maximum tolerated dose (MTD)…
- Trial name
- NCT02983604
- Testing
- GS-5829, Exemestane, Fulvestrant
- Where
- 6 sites in United States
- Volunteers
- 14 people
- Sponsor
- Gilead Sciences
Breast Cancer, Colorectal Cancer
A Study of Poziotinib in Patients With Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Activating Mutations in Advanced Malignancies
This is a Phase 2, open-label, multicenter study whose principal objectives are to evaluate the efficacy and safety/tolerability of poziotinib in five cohorts of 30 previously-treated patients each.
- Conditions
- Breast Cancer, Colorectal Cancer, Solid Tumor, Glioblastome Multiforme
- Trial name
- NCT04172597
- Testing
- Poziotinib Hydrochloride, Loperamide
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
HER2-positive Breast Cancer, HER2 Gene Mutation
Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
Open-label, Phase I-II, first-in-human (FIH) study for A166 monotherapy in HER2-expressing or amplified patients who progressed on or did not respond to available standard therapies.
- Conditions
- HER2-positive Breast Cancer, HER2 Gene Mutation, HER-2 Gene Amplification, HER2 Positive Gastric Cancer
- Trial name
- NCT03602079
- Testing
- A166
- Where
- 10 sites in United States
- Volunteers
- 49 people
- Sponsor
- Klus Pharma Inc.