Clinical trials: HER2 Negative
Metastatic Breast Cancer
A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi
This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs.
- Trial name
- BELLE-3 (NCT01633060)
- Testing
- Fulvestrant, BKM120
- Where
- 197 sites in United States, Argentina and 20 more
- Volunteers
- 432 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Invasive Breast Cancer
Onvansertib + Paclitaxel In TNBC
This research is being done to evaluate the safety and effectiveness of Onvansertib in combination with Paclitaxel in triple-negative breast cancer (TNBC) that has spread to other parts of the body.
- Conditions
- Breast Cancer, Invasive Breast Cancer, Unresectable Breast Carcinoma, Locally Advanced Breast Cancer
- Trial name
- NCT05383196
- Testing
- Onvansertib, Paclitaxel
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Antonio Giordano, MD
Breast Neoplasms, Locally Advanced or Metastatic Breast Cancer
Utidelone Plus Capecitabine Versus Taxane Plus Capecitabine in HER2-negative Locally Advanced or Metastatic Breast Cancer
It is a phase III trial to explore the efficacy and safety of utidelone plus capecitabine versus taxane plus capecitabine in HER2-negative locally advanced or metastatic breast cancer and the differences of metronomic…
- Trial name
- NCT05172518
- Testing
- Taxane plus Intermittent Capecitabine, Utidelone plus Intermittent Capecitabine, Taxane plus Metronomic Capecitabine
- Where
- China
- Volunteers
- 512 people
- Sponsor
- Sun Yat-sen University
Breast Cancer
Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer
Evaluation of the Efficacy and Safety of TQB3616 Capsules Combined with Hormonal Therapy in a Phase II Clinical Trial for Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor-Resistant, HR-Positive, HER2-Negative…
- Trial name
- NCT06702618
- Testing
- TQB3616 capsule+Fulvestrant Injection
- Where
- 13 sites in China
- Volunteers
- 33 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Breast Cancer, Triple Negative Breast Cancer
Safety and Efficacy of Durvalumab Combined to Neoadjuvant Chemotherapy in Localized Luminal B HER2(-) and Triple Negative Breast Cancer.
The study has a phase Ib and a phase II part. The phase Ib aims to evaluate the safety and tolerability of durvalumab in combination with a dose- dense EC regimen in a neoadjuvant setting for early breast cancer.
- Conditions
- Breast Cancer, Triple Negative Breast Cancer, Luminal B
- Trial name
- B-IMMUNE (NCT03356860)
- Testing
- Paclitaxel, Epirubicin, Cyclophosphamide
- Where
- 4 sites in Belgium
- Volunteers
- 57 people
- Sponsor
- Grand Hôpital de Charleroi
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer
This phase I trial tests the side effects and best dose of abemaciclib and niraparib in treating patients with breast cancer that is positive for estrogen or progesterone receptors (hormone receptor positive [HR+]) and HER2…
- 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
- NCT04481113
- Testing
- Abemaciclib, Niraparib Tosylate Monohydrate
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- OHSU Knight Cancer Institute
ER-positive, HER2-negative Breast Cancer, Breast Cancer Stage I
Capecitabine in ER+/HER2-negative Breast Cancer
This is a Phase 2 study for patients with resected Stage I-III HR+/HER2-negative breast cancer with detected molecular residual disease (MRD+) following standard neo/adjuvant and locoregional therapy delivered with curative…
- Conditions
- ER-positive, HER2-negative Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III
- Trial name
- NCT07631052
- Testing
- Capecitabine
- Where
- Canada
- Volunteers
- 15 people
- Sponsor
- University Health Network, Toronto
Breast Cancer
Combination Neoadjuvant Chemotherapy With or Without Apatinib for HER2 Negative Breast Cancer
RATIONALE: The combination of anti-angiogenic targeted therapy with neoadjuvant chemotherapy has been shown to further improve the pathologic response rate for HER2-negative breast cancer patients.
- Trial name
- APP (NCT03982485)
- Testing
- Apatinib, Paclitaxel, Cisplatin
- Where
- China
- Volunteers
- 196 people
- Sponsor
- RenJi Hospital
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
Breast Cancer Study of Stereotactic Body Radiation Therapy (SBRT) Combined Neoadjuvant Treatment
The study is being conducted to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) combined neoadjuvant treatment for patients with triple-negative and hormone receptor-positive, HER2-negative breast…
- Trial name
- NCT05132790
- Testing
- SHR-1316 at a dose 20mg/kg q3w, SHR6390 at a dose of 150mg orally, daily, SBRT
- Where
- China
- Volunteers
- 24 people
- Sponsor
- Shengjing Hospital
Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer
Comparing Endocrine Therapy Combined With High-Dose Palbociclib and Hydroxychloroquine to Endocrine Therapy Combined With Standard-Dose Palbociclib for Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer
This is a a phase III, randomized, open-label clinical trial comparing endocrine therapy combined with high-dose palbociclib and hydroxychloroquine to endocrine therapy combined with standard-dose palbociclib for hormone…
- Trial name
- NCT07061717
- Testing
- Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd, Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid, Palbociclib 200mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid
- Where
- China
- Volunteers
- 474 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Advanced Malignant Solid Neoplasm, Estrogen Receptor Negative
Glembatumumab Vedotin, Nivolumab, and Ipilimumab in Treating Patients With Advanced Metastatic Solid Tumors That Cannot Be Removed by Surgery
This phase Ib/II trial studies the best dose of glembatumumab vedotin when giving together with nivolumab and ipilimumab in treating patients with solid tumor that has spread to other places in the body and cannot be removed by…
- Conditions
- Advanced Malignant Solid Neoplasm, Estrogen Receptor Negative, GPNMB Positive, HER2/Neu Negative
- Trial name
- NCT03326258
- Testing
- Glembatumumab Vedotin, Ipilimumab, Laboratory Biomarker Analysis
- Sponsor
- National Cancer Institute (NCI)
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Letrozole With and Without Simvastatin for the Treatment of Stage I-III Hormone Receptor Positive, HER2 Negative Breast Cancer
This early phase I trial tests whether letrozole with simvastatin works better than letrozole alone to stop tumor cell proliferation in patients with stage I-III hormone receptor positive, HER2 negative invasive breast cancer.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, HER2-Negative Breast Carcinoma
- Trial name
- NCT05464810
- Testing
- Letrozole, Simvastatin
- Where
- 4 sites in United States
- Volunteers
- 40 people
- Sponsor
- Emory University
Breast Cancer Female, Stage II Breast Cancer
Predicting BReast cAncer Response to neoadjuVant Therapy by ctDNA Assessment
This is a prospective and observational study, aiming to determine the detection rate and change of CtDNA in blood samples of cancer patients before, during and after neoadjuvant treatment.
- Conditions
- Breast Cancer Female, Stage II Breast Cancer, Stage III Breast Cancer, HER2-positive Breast Cancer
- Trial name
- BRAVA (NCT06087120)
- Where
- 3 sites in Indonesia, Vietnam
- Volunteers
- 125 people
- Sponsor
- Gene Solutions
HER2-negative
NIS Study Determining Prevalence of HER2-low in Metastatic Breast Cancer Patients
This noninterventional, multicenter,retrospective study has been proposed to estimate the prevalence, clinicopathological characteristics,treatment patterns and clinical outcomes of human epidermal growth factor receptor 2…
- Trial name
- iRetroBC (NCT06131424)
- Where
- 31 sites in Argentina, Brazil and 11 more
- Volunteers
- 1,151 people
- Sponsor
- AstraZeneca
Breast Cancer
Phase II Trial of Neoadjuvant Metronomic Chemotherapy in Triple-Negative Breast Cancer
This neoadjuvant chemotherapy protocol focusing on "triple-negative" breast cancers alone will gather a foundation of primary tumor and axillary lymph nodal response to primary chemotherapy and ongoing correlated disease-free…
- Trial name
- NCT00542191
- Testing
- Doxorubicin / Cyclophosphamide / Paclitaxel / Carboplatin, Definitive Surgery, Radiotherapy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Leo W. Jenkins Cancer Center
Metastatic Breast Cancer, ER Positive Breast Cancer
To Identify Primary Resistance to CDK4/6 Inhibitors in Breast Cancer
This is a multi-center biomarkers study aiming to prospectively collect biological samples from patients with ER+ and HER2-negative metastatic breast cancer, who are candidate to first-line treatment with an aromatase inhibitor…
- Conditions
- Metastatic Breast Cancer, ER Positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- TIRESIAS (NCT04660435)
- Testing
- Thymidine kinase activity
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- Fondazione Sandro Pitigliani
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
Circulating Tumor DNA Based Minimal Residual Disease Detection for Patients With Early-Stage Breast Cancer
This clinical trial studies how well circulating tumor deoxyribonucleic acid (ctDNA) based minimal residual disease (MRD) detection works for patients with early-stage breast cancer.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Estrogen Receptor-Positive Breast Carcinoma
- Trial name
- NCT07136493
- Testing
- Biospecimen Collection, Electronic Health Record Review, Survey Administration
- Where
- 5 sites in United States
- Sponsor
- City of Hope Medical Center
Breast Cancer
A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with…
- Trial name
- SANDPIPER (NCT02340221)
- Testing
- Taselisib, Fulvestrant
- Where
- 157 sites in United States, Australia and 26 more
- Volunteers
- 631 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer, Locally Advanced Breast Cancer
Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer
To determine how long Gemcitabine and Bevacizumab will stop the cancer from growing in patients with advanced breast cancer.
- Trial name
- NCT00623233
- Testing
- Gemcitabine, Bevacizumab
- Where
- 16 sites in United States
- Volunteers
- 52 people
- Sponsor
- Eli Lilly and Company