Clinical trials: HER2-Positive Breast Cancer
Advanced Solid Tumors, HER2-positive Breast Cancer
Trial of ZN-A-1041 Enteric Capsules in Patients With HER2-Positive Advanced Solid Tumors
This will be a phase 1, multicenter, open-label trial to evaluate the safety, tolerability, PK and efficacy of ZN-A-1041 as a monotherapy or in combination in patients with HER2-positive advanced solid tumors.
- Trial name
- NCT04487236
- Testing
- ZN-A-1041 50mg BID, ZN-A-1041 100mg BID, ZN-A-1041 200mg BID
- Where
- China
- Volunteers
- 61 people
- Sponsor
- Suzhou Zanrong Pharma Limited
Breast Cancer
Evaluation of Orally Administered Amcenestrant (SAR439859) in Japanese Postmenopausal Patients With Advanced Breast Cancer (AMEERA-2)
Primary Objective: To assess the incidence rate of dose-limiting toxicity and to confirm the recommended dose as well as the maximum tolerated dose of SAR439859 administered as monotherapy to Japanese postmenopausal women with…
- Trial name
- AMEERA-2 (NCT03816839)
- Testing
- Amcenestrant (SAR439859)
- Where
- 3 sites in Japan
- Volunteers
- 10 people
- Sponsor
- Sanofi
HER2-positive Breast Cancer
Identification of Genetic Determinants for Treatment Resistance/Sensitivity and/or Toxicity in Adjuvant Setting for HER2 Positive Breast Cancer
This is a multicenter, non-randomized, prospective cohort study. The purpose of the study is to identify constitutional genetic factors associated with histological response, resistance or sensibility to treatment in human…
- Trial name
- SIGHER (NCT04638725)
- Testing
- Blood sample for genetic analysis
- Where
- France
- Volunteers
- 9,000 people
- Sponsor
- Centre Paul Strauss
HER2-positive Breast Cancer
Patients With Brain Metastases From HER2-positive Breast Cancer
The purpose of this study is to determine the optimal sequences of combined trastuzumab emtansine (T-DM1) and whole-brain radiotherapy in patients presenting brain metastases from HER2-positive breast cancer in terms of acute…
- Trial name
- BIRTH (NCT02135159)
- Testing
- TDM1, Brain Sequential RT
- Where
- France
- Volunteers
- 36 people
- Sponsor
- Institut du Cancer de Montpellier - Val d'Aurelle
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
Early Breast Cancer
Chemotherapy-Free pCR-Guided Strategy With Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer
This is a multicenter, open-label, single-arm, one-stage, phase II study to assess the efficacy of a chemotherapy-free pathological complete response (pCR)-guided strategy with trastuzumab and pertuzumab (given as a subcutaneous…
- Trial name
- PHERGAIN-2 (NCT04733118)
- Testing
- Trastuzumab and Pertuzumab (FDC SC) and T-DM1
- Where
- 41 sites in Bulgaria, Germany and 3 more
- Volunteers
- 393 people
- Sponsor
- MedSIR
Breast Cancer
Study With Docetaxel, Carboplatin and Herceptin Versus Vinorelbine and Herceptin in HER-2 (+) Metastatic Breast Cancer Patients
This trial will compare the efficacy of sequential administration of Docetaxel, Carboplatin and Herceptin versus the administration of Vinorelbine and Herceptin combination as first line treatment in HER-2 positive patients with…
- Trial name
- NCT00453635
- Testing
- Docetaxel, Carboplatin, Herceptin
- Where
- 10 sites in Greece
- Volunteers
- 88 people
- Sponsor
- Hellenic Oncology Research Group
Breast Cancer Stage IV
Simvastatin Plus Dual Anti-HER2 Therapy for Metastatic Breast Cancer
This study recruits patients with metastatic breast cancer who have progressed on their current regimen of dual anti-HER2 therapy.
- Trial name
- SIMPHONY (NCT03324425)
- Testing
- Simvastatin 80mg
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Baylor Breast Care Center
Breast Cancer
microRNA of Human Epidermal Growth Factor Receptor 2 （HER2）Positive Patient Treated With Herceptin
This projective observational study is planned to enroll more than 300 advanced breast cancer patients, who were proved as Her-2 positive using fluorescence in situ hybridization (FISH) and / or immunohistochemistry, and 100…
- Trial name
- NCT02656589
- Testing
- Capecitabine, Trastuzumab
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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
Triple Negative Breast Cancer (TNBC), HER2-Positive Breast Cancer
Home-Based Exercise Program During Neoadjuvant Treatment to Improve Fatigue and Quality of Life in Early HER2-Positive and Triple-Negative Breast Cancer Patients
The goal of this trial is to learn if a home-based exercise program (intervention) reduces fatigue and improves quality of life in adult patients with early breast cancer who are proposed for preoperative chemotherapy.
- Conditions
- Triple Negative Breast Cancer (TNBC), HER2-Positive Breast Cancer, Early Breast Cancer, Cancer-related Fatigue
- Trial name
- HoPEx-Breast (NCT06782698)
- Testing
- Home-based exercise program, Promotion of Healthy Physical Activity
- Where
- Portugal
- Volunteers
- 50 people
- Sponsor
- Centro Hospitalar Universitário de Santo António
Metastatic Breast Cancer
Evaluate Safety, Efficacy and Pharmacokinetics
The purpose of the study is to demonstrate equivalent pharmacokinetics (PK)
- Trial name
- Compare (NCT01084863)
- Testing
- CT-P6, Herceptin, Paclitaxel
- Where
- South Korea
- Volunteers
- 143 people
- Sponsor
- Celltrion
Breast Cancer
Palbociclib Combined With an Aromatase Inhibitor in Breast Cancer
Pfizer's innovative drug palbociclib (trade name: Ibrance®) got China National Drug Administration (CNDA) approval on July 31, 2018.
- Trial name
- NCT04047758
- Testing
- Palbociclib + Letrozole, Letrozole
- Where
- 3 sites in China
- Volunteers
- 420 people
- Sponsor
- Shengjing Hospital
Breast Cancer
Treatment Decision Impact of OncotypeDX™ in HR+, N- Breast Cancer Patients
Primary objective: Determine the impact of the Oncotype DX Recurrence Score (RS) on the treatment recommendation made (administration of chemotherapy or not, in addition to hormonotherapy) in a HR+, N- or pN1(mi), Her2- breast…
- Trial name
- SWITCH (NCT01446185)
- Testing
- Oncotype DX breast cancer test
- Where
- 6 sites in France
- Volunteers
- 100 people
- Sponsor
- Genomic Health®, Inc.
Breast Neoplasms
A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several immunotherapy-based combination treatments in participants with inoperable locally advanced or metastatic HR-positive, HER2-negative breast…
- Trial name
- MORPHEUS HR+BC (NCT03280563)
- Testing
- Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody, Bevacizumab, Entinostat
- Where
- 22 sites in United States, Israel and 1 more
- Volunteers
- 144 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study of Herceptin (Trastuzumab) in Combination With 2nd-Line Chemotherapy in Patients With HER2 Positive Metastatic Breast Cancer.
This 2 arm study will compare the efficacy and safety of continuation or discontinuation of Herceptin treatment in combination with 2nd line chemotherapy, in patients with HER2 positive metastatic breast cancer whose condition…
- Trial name
- NCT00444587
- Testing
- Second line chemotherapy, trastuzumab [Herceptin]
- Where
- 30 sites in Bulgaria, Estonia and 6 more
- Volunteers
- 114 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor
This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal…
- Trial name
- BELLE-2 (NCT01610284)
- Testing
- Fulvestrant, BKM120
- Where
- 268 sites in United States, Argentina and 27 more
- Volunteers
- 1,147 people
- Sponsor
- Novartis Pharmaceuticals
HER2-positive Breast Cancer, Advanced Breast Cancer
The Efficacy and Safety of Pyrotinib, Trastuzumab Combined With Taxanes in the Treatment of Trastuzumab-treated HER2+ Advanced Breast Cancer (ABC).
This is a multi-center real-world study, in which patients who meet the inclusion criteria will receive treatment with Pyrotinib + Trastuzumab + Taxanes.
- Trial name
- NCT06217185
- Testing
- Pyrotinib, Trastuzumab, Taxanes
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Hebei Medical University Fourth Hospital
Breast Cancer, Metastatic, HER2 + Breast Cancer
Personalized Detection of ctDNA for Patients With HER2-Positive Metastatic Breast Cancer Patients Who Achieved Durable Response to Anti-HER2 Treatment
Anti-HER2 therapy, such as trastuzumab and pertuzumab, has significantly improved long-term survival in HER2-positive breast cancer.
- Trial name
- HER2 CR (NCT06663787)
- Testing
- Trastuzumab (Herceptin), SIgnatera
- Where
- 4 sites in United States, Japan
- Volunteers
- 50 people
- Sponsor
- Nagoya City University
HR Positive/HER2 Negative Advanced or Metastatic Breast Cancer
A Phase III Clinical Trial of NTQ1062 in Combination With Fulvestrant for the Treatment of Advanced or Metastatic HR+/HER2- Breast Cancer
NTQ1062-301 is a randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of the small-molecule AKT inhibitor NTQ1062 combined with fulvestrant versus placebo combined with…
- Trial name
- NCT07393321
- Testing
- NTQ1062+Fulvestrant
- Volunteers
- 210 people
- Sponsor
- Nanjing Chia-tai Tianqing Pharmaceutical