Clinical trials: HER2 Negative Breast Cancer
Advanced/Metastatic HER2-negative Breast Cancer
Real-World Outcomes of Patients With Metastatic Breast Cancer After Treatment With First-Line ET+CDK4/6i
This study aims to assess the treatment patterns and real-world outcomes of HR+/HER- metastatic breast cancer patients who have progressed on 1L ET + CDK4/6i and started a second line (2L) treatment within a real-world cohort in…
- Trial name
- NCT06975371
- Testing
- No drug
- Where
- United States
- Volunteers
- 1,415 people
- Sponsor
- Daiichi Sankyo
Breast Neoplasms, Neoplasms
Study Evaluating HKI-272 (Neratinib) In Subjects With Advanced Breast Cancer
The purpose of this study is to learn whether neratinib is safe and effective in treating women with advanced human epidermal growth factor receptor 2 (HER2) positive breast cancer.
- Trial name
- NCT00300781
- Testing
- neratinib
- Where
- 33 sites in United States, Belgium and 5 more
- Volunteers
- 136 people
- Sponsor
- Puma Biotechnology, Inc.
Advanced Solid Tumor, Metastatic Solid Tumor
Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)
This interventional study will evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of ART6043 as monotherapy or in combination with olaparib.
- Trial name
- NCT05898399
- Testing
- ART6043, Olaparib
- Where
- 27 sites in United States, Spain and 1 more
- Volunteers
- 181 people
- Sponsor
- Artios Pharma Ltd
Breast Cancer
Gut and Tumor Microbiome in Patients With Early Stage (II-III), Locally Advanced or Advanced ER-positive and HER2-negative Breast Cancer.
The purpose of this research study is to collect samples of blood and stool and analyse primary tumor from participants with breast cancer to see how the bacteria in the body affect cancer and how well it responds to treatment.
- Trial name
- NCT06126003
- Testing
- Observation
- Where
- 6 sites in United States
- Volunteers
- 2 people
- Sponsor
- BioCorteX Inc
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
Breast Cancer, Advanced Breast Cancer
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one…
- Conditions
- Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer
- Trial name
- OPERA-01 (NCT06016738)
- Testing
- Palazestrant, Fulvestrant, Anastrozole
- Where
- 233 sites in United States, Argentina and 24 more
- Volunteers
- 510 people
- Sponsor
- Olema Pharmaceuticals, Inc.
Metastatic Breast Cancer
A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer
The aim of this study is to evaluate the efficacy and safety of ESG401 in patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer.
- Trial name
- NCT06383767
- Testing
- ESG401, Eribulin, capecitabine, gemcitabine or vinorelbine (Treatment of Physician's Choice)
- Where
- China
- Volunteers
- 378 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Advanced Solid Tumor, Advanced Malignant Neoplasm
The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
The Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C…
- Conditions
- Advanced Solid Tumor, Advanced Malignant Neoplasm, Metastatic Cancer, Metastatic Solid Tumor
- Trial name
- NCT04585750
- Testing
- rezatapopt, pembrolizumab
- Where
- 76 sites in United States, Australia and 7 more
- Volunteers
- 300 people
- Sponsor
- PMV Pharmaceuticals, Inc
HR-positive, HER2-negative Advanced Breast Cancer
Study of TYK-00540 Tablets in Patients With Advanced Solid Tumors
This study is to evaluate the safety, pharmacokinetics, and preliminary antitumor activity of TYK-00540 as monotherapy or combined with fulvestrant in advanced solid tumors.
- Trial name
- NCT06950086
- Testing
- TYK-00540
- Where
- 2 sites in China
- Volunteers
- 180 people
- Sponsor
- TYK Medicines, Inc
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.
Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer
A Study to Learn How Well Participants With a Specific Type of Early Breast Cancer (ER-Positive, HER2-Negative) Tolerate and Stay on Treatment With Giredestrant and How They Feel During Treatment
The purpose of this study is to evaluate treatment adherence, tolerability, and patient-reported outcomes of participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast…
- Conditions
- Early Breast Cancer, Estrogen Receptor-Positive Breast Cancer, HER2-Negative Breast Cancer
- Trial name
- kalitERA (NCT07827573)
- Testing
- Giredestrant
- Where
- Canada
- Volunteers
- 1,500 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer, HER2+ Breast Cancer
Phase 1b/2 Study of BKM120 Plus Trastuzumab in Patients With HER2-positive Breast Cancer
This study will assess the safety and efficacy of BKM120 in combination with trastuzumab in patients with relapsing HER2 overexpressing breast cancer who have previously failed trastuzumab.
- Trial name
- NCT01132664
- Testing
- BKM120, Trastuzumab, Capecitabine
- Where
- 21 sites in United States, Belgium and 4 more
- Volunteers
- 72 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
An Observational Study of Avastin (Bevacizumab) in Patients With HER2-metastatic or Locally Advanced Breast Cancer
This observational study will evaluate the safety and efficacy of triple negative or HR+ patients with HER2-metastatic or locally advanced breast cancer treated with Avastin (bevacizumab) as first line therapy for at least 12…
- Trial name
- NCT01461044
- Where
- 82 sites in France
- Volunteers
- 228 people
- Sponsor
- Hoffmann-La Roche
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
Locally Recurrent and Metastatic Breast Cancer
Phase 2 Study of AMG 386 Plus Paclitaxel With or Without Bevacizumab as First Line Therapy in Her2-Negative Breast Cancer Patients
This is a phase 2, randomized, placebo controlled, multi-center study to estimate the treatment effect and evaluate the safety and tolerability of AMG 386 in combination with paclitaxel and paclitaxel/bevacizumab in the treatment…
- Trial name
- NCT00511459
- Testing
- AMG 386, Bevacizumab, Paclitaxel
- Where
- 77 sites in United States, Australia and 11 more
- Volunteers
- 228 people, healthy volunteers welcome
- Sponsor
- Amgen
Breast Cancer
A Study of Pegylated Liposomal Doxorubicin and Cyclophosphamide in Her2-negative Stage I and II Breast Cancer Patients
Primary objective: To evaluate the disease-free survival (DFS) in the two randomized arms after therapy with LC vs. EC in chemo-naive Her2-patients with stage I or II breast cancer Secondary objectives: To assess the overall…
- Trial name
- NCT01210768
- Testing
- Epirubicin+Cyclophosphamide, liposomal-doxorubicin+Cyclophosphamide
- Where
- 9 sites in Taiwan
- Volunteers
- 254 people
- Sponsor
- TTY Biopharm
Breast Cancer
A Study of Ipatasertib Plus Palbociclib and Fulvestrant Versus Placebo Plus Palbociclib and Fulvestrant in Hormone Receptor Positive and HER2 Negative Locally Advanced Unresectable or Metastatic Breast Cancer
The open-label Phase Ib portion of this study will evaluate the safety and pharmacokinetics of ipatasertib in combination with palbociclib and fulvestrant to identify a dose of ipatasertib that can be combined with palbociclib…
- Trial name
- IPATunity150 (NCT04060862)
- Testing
- Ipatasertib, Palbociclib, Fulvestrant
- Where
- 20 sites in United States, Australia and 6 more
- Volunteers
- 20 people
- Sponsor
- Hoffmann-La Roche
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
Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer
Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy
- Trial name
- OlympiA (NCT02032823)
- Testing
- Olaparib
- Where
- 698 sites in United States, Argentina and 22 more
- Volunteers
- 1,837 people
- Sponsor
- AstraZeneca
Breast Cancer
Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant
The purpose of this clinical trial is to study of the molecular features of postmenopausal women with hormone receptor-positive (HR+) HER2-negative advanced breast cancer on first-line treatment with ribociclib and letrozole and…
- Trial name
- BioItaLEE (NCT03439046)
- Testing
- Ribociclib, Letrozole, Alpelisib
- Where
- 41 sites in Italy
- Volunteers
- 287 people
- Sponsor
- Novartis Pharmaceuticals