Clinical trials: HER2 Negative Breast Cancer
Breast Cancer
Study to Evaluate Efficacy & Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer
Study LAE205INT3101 is a Phase Ib/III study to evaluate the efficacy and safety of the combination therapy with afuresertib plus fulvestrant (afuresertib/placebo plus fulvestrant in Phase III) in patients with HR+/HER2- breast…
- Trial name
- NCT04851613
- Testing
- Afuresertib
- Where
- 55 sites in United States, China
- Volunteers
- 256 people
- Sponsor
- Laekna Limited
HER2-positive Breast Cancer
MagSense® Human Epidermal Growth Factor Receptor 2 (HER2) Imaging Agent (MSH2IA)
This Phase 1b/2 study is designed as an open-label, multicenter, 3 group, interventional study in which Phase 1b will evaluate the pharmacokinetics (PK) of MSH2IA and Phase 2 will confirm lowest effective dose as well as evaluate…
- Trial name
- NCT07885683
- Testing
- The MagSense® HER2 Imaging Agent (MSH2IA)
- Volunteers
- 70 people
- Sponsor
- Imagion Biosystems, Inc.
Breast Cancer
A Study of SI-B003 or BL-B01D1+SI-B003 in Patients With Unresectable Locally Advanced or Recurrent Metastatic HER2 Negative Breast Cancer
This phase II study is a clinical study to explore the efficacy and safety of SI-B003 monotherapy and BL-B01D1+SI-B003 combination therapy in patients with unresectable locally advanced or recurrent metastatic HER-2 negative…
- Trial name
- NCT06042894
- Testing
- BL-B01D1, SI-B003
- Where
- China
- Volunteers
- 58 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Adenocarcinoma
Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors
The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617 (REC-617) in participants with advanced solid tumors.
- Conditions
- Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Adenocarcinoma, Non-small Cell Lung Cancer (NSCLC), Platinum-resistant High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers (HGSOC)
- Trial name
- ELUCIDATE (NCT05985655)
- Testing
- GTAEXS617, SoC
- Where
- 15 sites in United States, Belgium and 1 more
- Volunteers
- 230 people
- Sponsor
- Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Early Breast Cancer
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Giredestrant Plus Palbociclib Compared With Anastrozole Plus Palbociclib for Postmenopausal Women With Estrogen Receptor-Positive and HER2-Negative Untreated Early Breast Cancer (coopERA Breast Cancer)
This is a randomized, multicenter, open-label, two-arm, Phase II study to evaluate the efficacy, safety, and pharmacokinetics of giredestrant versus anastrozole (in the window-of-opportunity phase) and giredestrant plus…
- Trial name
- NCT04436744
- Testing
- Giredestrant, Anastrozole, Palbociclib
- Where
- 65 sites in United States, Australia and 9 more
- Volunteers
- 221 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer
This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and…
- Trial name
- NCT02684032
- Testing
- Gedatolisib, Palbociclib, Letrozole
- Where
- 41 sites in United States
- Volunteers
- 141 people
- Sponsor
- Celcuity Inc
Advanced Breast Cancer, Advanced or Metastatic Breast Cancer
A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors
The purpose of this study is to learn about the safety and effects of the study medicine (called PF-08165784) when given alone or together with other anti-cancer therapies.
- Conditions
- Advanced Breast Cancer, Advanced or Metastatic Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Metastatic Colorectal Adenocarcinoma
- Trial name
- NCT07897721
- Testing
- PF-08165784, Fulvestrant, Atirmociclib
- Volunteers
- 268 people
- Sponsor
- Pfizer
Postmenopausal Women With ER+ HER2- Primary Breast Cancer
Study to Compare the Effects of AZD9496 vs Fulvestrant in Breast Cancer.
This is an open label randomised multicentre pre-surgical pharmacodynamics study to compare and assess the biological effects of AZD9496 and fulvestrant in postmenopausal women with estrogen receptor (ER) positive (ER+), human…
- Trial name
- D6090C00002 (NCT03236974)
- Testing
- Standard Arm - Fulvestrant, AZD9496
- Where
- 12 sites in Germany, United Kingdom
- Volunteers
- 49 people
- Sponsor
- AstraZeneca
Breast Cancer
Study to Compare the Combination of Ribociclib Plus Goserelin Acetate With Hormonal Therapy Versus Combination Chemotherapy in Premenopausal or Perimenopausal Patients With Advanced or Metastatic Breast Cancer
To compare the combination of Ribociclib plus goserelin acetate with hormonal therapy versus combination chemotherapy in premenopausal or perimenopausal patients with advanced or metastatic breast cancer
- Trial name
- RIGHT Choice (NCT03839823)
- Testing
- Docetaxel / Capecitabine, Capecitabine / Vinorelbine, Paclitaxel / Gemcitabine
- Where
- 50 sites in Egypt, India and 11 more
- Volunteers
- 222 people
- Sponsor
- Novartis Pharmaceuticals
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.
Breast Cancer
Danish Observational Study of Everolimus Plus Exemestane in Hormone Receptor (HR) Positive, Human Epidermal Growth Factor 2 (HER2) - Metastatic Breast Cancer
An observational study in patients with advanced ER+, HER2 negative breast cancer, who are treated with everolimus and exemestane in combination.
- Trial name
- NCT02023359
- Testing
- Everolimus and exemestane
- Where
- 3 sites in Denmark
- Volunteers
- 7 people
- Sponsor
- Novartis Healthcare A/S
Breast Cancer
A Study to Learn About the Safety of TALZENNA for the Treatment of Breast Cancer
The purpose of this study is to learn about the safety of TALZENNA for the patients with breast cancer that cannot be removed by surgery and has come back.
- Trial name
- NCT06735742
- Where
- Japan
- Volunteers
- 3 people
- Sponsor
- Pfizer
Breast Cancer
A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer
This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with…
- Trial name
- NCT06112379
- Testing
- Dato-DXd, Durvalumab, Pembrolizumab
- Where
- 283 sites in United States, Australia and 24 more
- Volunteers
- 1,902 people
- Sponsor
- AstraZeneca
Breast Cancer
Estimation of the Prevalence of HER2 Low and Describe the SoC, Treatment Patterns, and Outcome in Real-world Practice Among Unresectable and/or Metastatic Breast Cancer Patients With HER2 Low Status
This is a worldwide, multicenter, non-interventional, retrospective study of patient medical records from metastatic breast cancer (mBC) patients previously identified as human epidermal growth factor receptor 2 negative…
- Trial name
- NCT04807595
- Testing
- None (Observational study)
- Where
- 13 sites in United States, Australia and 8 more
- Volunteers
- 798 people
- Sponsor
- AstraZeneca
Breast Cancer, TNBC - Triple-Negative Breast Cancer
A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer
This is an adaptive Phase 2, open-label, randomized, multi-center study evaluating up to 2 regimens of PCS6422 with capecitabine (Cap) vs. standard dose of Cap alone in patients with advanced or metastatic breast cancer.
- Conditions
- Breast Cancer, TNBC - Triple-Negative Breast Cancer, HER2-negative Breast Cancer
- Trial name
- NCT06568692
- Testing
- PCS6422 and capecitabine, Capecitabine
- Where
- 12 sites in United States
- Volunteers
- 20 people
- Sponsor
- Processa Pharmaceuticals
Early Breast Cancer
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free…
- Trial name
- Adjuvant WIDER (NCT05827081)
- Testing
- Ribociclib, Letrozole, Ansastrozole
- Where
- 214 sites in United States, Argentina and 14 more
- Volunteers
- 1,464 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer Metastatic
A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study
The purpose of this study is to find out the possible anti-cancer effect of pelareorep in combination with chemotherapy [paclitaxel] and avelumab in treating a type of breast cancer called Hormone Receptor positive (HR+)/Human…
- Trial name
- NCT04215146
- Testing
- Paclitaxel, Pelareorep, Avelumab
- Where
- 18 sites in United States
- Volunteers
- 48 people
- Sponsor
- Oncolytics Biotech
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
The purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer.
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Colorectal Cancer, Metastatic Colorectal Adenocarcinoma
- Trial name
- NCT07318805
- Testing
- PF-08032562, Fulvestrant, Cetuximab
- Where
- 13 sites in United States
- Volunteers
- 260 people
- Sponsor
- Pfizer
Pancreatic Adenocarcinoma Metastatic, BRCA1 Mutation
SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells
The clinical trial is a phase 1, single-arm trial that will evaluate the safety of the investigational treatment on metastatic pancreatic cancer and metastatic breast cancer.
- Conditions
- Pancreatic Adenocarcinoma Metastatic, BRCA1 Mutation, BRCA2 Mutation, Pancreatic Acinar Cell Carcinoma
- Trial name
- SHARON (NCT04150042)
- Testing
- Melphalan, BCNU, Vitamin B12B
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- General Oncology, Inc.
Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC)
JSKN016 in Combination With D-0502 for Locally Advanced or Metastatic HR-Positive, HER2-Negative Breast Cancer
This is a multicenter, open-label, Phase Ib/II randomized study designed to evaluate the safety, tolerability, dose-limiting toxicities (DLTs), and preliminary antitumor activity of JSKN016 in combination with the oral selective…
- Trial name
- NCT07336771
- Testing
- JSKN016 Q2W, JSKN016 Q3W, D-0502
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd