Clinical trials: Her2-negative Metastatic Breast Cancer
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.
Tubular Breast Cancer Stage II, Mucinous Breast Cancer Stage II
Addition of Carboplatin to Neoadjuvant Therapy for Triple-negative and HER2-positive Early Breast Cancer
Study participants with primary breast cancer will receive a standard chemotherapy with an anthracycline and a taxane as well as trastuzumab in case of HER2-positive tumors at doses and duration in concordance to current…
- Conditions
- Tubular Breast Cancer Stage II, Mucinous Breast Cancer Stage II, Breast Cancer Female NOS, Invasive Ductal Breast Cancer
- Trial name
- GeparSixto (NCT01426880)
- Testing
- Carboplatin, background treatment
- Where
- 3 sites in Germany
- Volunteers
- 595 people
- Sponsor
- GBG Forschungs GmbH
Metastatic Breast Cancer, HER2 Low Breast Carcinoma
ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer
The goal of this study is to evaluate the safety and efficacy of elacestrant in combination with trastuzumab deruxtecan (T-DXd) in participants with hormone receptor-positive (HR+), HER2-low or HER2-ultralow, metastatic breast…
- Conditions
- Metastatic Breast Cancer, HER2 Low Breast Carcinoma, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- ERADICATE (NCT07198724)
- Testing
- Elacestrant, Trastuzumab Deruxtecan
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Kristina A. Fanucci
Breast Cancer
An Open-Label, Expanded Access Protocol of Iniparib Breast Cancer
The following trial is designed to offer pre-approval drug access to iniparib in combination with gemcitabine and carboplatin in order to provide potential clinical benefit to patients with ER-, PR-, and HER2-negative metastatic…
- Trial name
- NCT01130259
- Testing
- iniparib
- Sponsor
- Sanofi
Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)
This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with…
- Trial name
- NCT05306340
- Testing
- Giredestrant, Exemestane, Fulvestrant
- Where
- 136 sites in United States, Argentina and 11 more
- Volunteers
- 373 people
- Sponsor
- Genentech, Inc.
Breast Cancer
Sac-TMT Plus KL-A167 in PD-L1+, HR+/HER2- Metastatic Breast Cancer After CDK4/6 Inhibitors
This is a Phase II single-arm study designed to evaluate the efficacy and safety of Sac-TMT + KL-A167 in 35 patients with PD-L1+, HR+/HER2- metastatic breast cancer who previously treated with CDK4/6 inhibitor.
- Trial name
- NCT07258108
- Testing
- Lucanisatuzumab plus tagolimumab
- Where
- China
- Volunteers
- 35 people
- Sponsor
- Sun Yat-sen University
Breast Cancer
Neurotoxicity Characterization Study of Nab-paclitaxel Versus Conventional Paclitaxel in Metastatic Breast Cancer
Nanomedicines are currently being developed in the treatment of cancer due to their pharmacological advantages over traditional formulations; they provide a shorter infusion time and lower risks of hypersensitivity reactions…
- Trial name
- neurabrax (NCT01763710)
- Testing
- Paclitaxel 80 mg/m2, Nab-paclitaxel 100 mg/m2 days 1, 8 and 15, Nab-paclitaxel 150 mg/m2 days 1, 8 and 15
- Where
- 10 sites in Spain
- Volunteers
- 60 people
- Sponsor
- Fundacion Oncosur
Metastatic Breast Cancer, Triple Negative Breast Cancer
Toci +/- SOC Chemo for Metastatic Triple Negative and ER-positive, HER2-negative Breast Cancers
This is a randomized Phase II study of standard of care (SOC) chemotherapy monotherapy vs. SOC chemotherapy combined with tocilizumab biosimilar in Black and non-Black patients with metastatic triple negative and ER-positive…
- Conditions
- Metastatic Breast Cancer, Triple Negative Breast Cancer, Estrogen-receptor-low Breast Cancer, ER Positive, HER2 Negative Breast Cancer
- Trial name
- NCT05846789
- Testing
- SOC Chemotherapy, Tocilizumab/Tocilizumab Biosimilar
- Where
- 7 sites in United States
- Volunteers
- 168 people
- Sponsor
- Kathy Miller
Breast Cancer, Locally Advanced or Metastatic Solid Tumor
A Study of BL-M07D1 in Patients With Locally Advanced or Metastatic HER2-Positive/Negative Breast Cancer and Other Solid Tumors
In phase Ia study, the safety and tolerability of BL-B07D1 in patients with locally advanced or metastatic HER2-positive/low-expression breast cancer and other solid tumors will be investigated to determine the dose-limiting…
- Trial name
- NCT05461768
- Testing
- BL-M07D1
- Where
- 7 sites in China
- Volunteers
- 348 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Breast Cancer
DiEtary Mimicry by Glucocorticoid Modulation Evaluation in ER+ Metastatic Breast Cancer Treatment: Efficacy and Response (DEMETER Trial)
This is a single centre, open label, phase II clinical study consisting of two parts, each consisting of a different dose of the same intervention to investigate the efficacy of dexamethasone as an adjunct to endocrine therapy in…
- Trial name
- DEMETER (NCT07786051)
- Testing
- Dexamethasone (Oral)
- Volunteers
- 80 people
- Sponsor
- The Netherlands Cancer Institute
Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
Efficacy Study of Herceptin to Treat HER2-negative CTC Breast Cancer
This is a randomized phase II trial for patients with HER2 negative primary Breast Cancer (BC) who after completing (neo) adjuvant chemotherapy and surgery have detectable circulating tumour cells (CTC) in peripheral blood.
- Conditions
- Breast Cancer, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, Circulating Tumor Cells
- Trial name
- TREAT-CTC (NCT01548677)
- Testing
- trastuzumab
- Where
- 80 sites in Belgium, France and 2 more
- Volunteers
- 1,317 people
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC
Stage IV (Metastatic) Breast Cancer, Metastatic Breast Cancer
Fulvestrant + Neratinib In Breast Cancer
This is a Phase 2 open label, multi-center non-randomized interventional study designed to evaluate the safety and efficacy of combining Neratinib plus Fulvestrant in previously treated metastatic HR-positive, HER2-negative…
- Conditions
- Stage IV (Metastatic) Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer, PR-Positive Breast Cancer
- Trial name
- HER2-Signal (NCT04901299)
- Testing
- NERATINIB, FULVESTRANT
- Where
- 2 sites in United States
- Sponsor
- Massachusetts General Hospital
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer
This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Locally Advanced Breast Carcinoma
- Trial name
- NCT07137416
- Testing
- Biopsy Procedure, Biospecimen Collection, Echocardiography Test
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- National Cancer Institute (NCI)
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.
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Genetic Testing in Predicting Tumor Response in Patients With Stage I-III HER2 Negative Invasive Breast Cancer
This phase II trial studies how well genetic testing works in predicting tumor response in patients with stage I-III HER2 negative invasive breast cancer.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
- Trial name
- NCT01334021
- Testing
- Biopsy, Conventional Surgery, Genetic Testing
- Where
- United States
- Volunteers
- 1,100 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Cancer
A Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects With HER2 Negative Metastatic Breast Cancer
The purpose of this study is to evaluate survival, response rate, safety and tolerability of YM155 given in combination with docetaxel as first-line treatment in subjects with human epidermal growth factor 2 non-overexpressing…
- Trial name
- NCT01038804
- Testing
- YM155, Docetaxel
- Where
- 30 sites in United States, Belgium and 6 more
- Volunteers
- 101 people
- Sponsor
- Astellas Pharma Inc
Advanced Breast Adenocarcinoma, Advanced HER2-Negative Breast Carcinoma
Effects of Ribociclib and Palbociclib on Tumor and Blood Characteristics in Patients With Metastatic Breast Cancer
This clinical trial attempts to understand the differences between two chemotherapy drugs, ribociclib and palbociclib, and how they fight cancer.
- Conditions
- Advanced Breast Adenocarcinoma, Advanced HER2-Negative Breast Carcinoma, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
- Trial name
- NCT05244434
- Testing
- Best Practice, Biopsy, Biospecimen Collection
- Sponsor
- City of Hope Medical Center
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
Palbociclib in Combination With Fulvestrant or Letrozole in Patients With ER+, HER2- Advanced Breast Cancer
This is an international, randomized, open-label, controlled, multicenter phase II clinical trial to investigate and compare the safety and efficacy of palbociclib combined with fulvestrant or letrozole in women with ER+, HER2…
- Trial name
- PARSIFAL (NCT02491983)
- Testing
- Palbociclib, Fulvestrant, Letrozole
- Where
- 48 sites in Czechia, France and 5 more
- Volunteers
- 486 people
- Sponsor
- MedSIR
Metastatic Breast Cancer
Phase II Open-Label Trial of Tarceva in Women With Metastatic, Hormone- and HER2-Negative Breast Cancer
The goal of this trial is to determine the activity of erlotinib in a rationally selected population of women with ER-negative, PR-negative, HER2/neu-negative, EGFR-positive breast cancer.
- Trial name
- NCT00597597
- Testing
- Erlotinib
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Rush University Medical Center