Clinical trials: HER2 Positive Breast Carcinoma, open to volunteers
HER2-positive Breast Cancer
SHR-A1811 Monotherapy or Sequential THPy as Neoadjuvant Therapy for Stage II-III HER2-Positive Breast Cancer
This is a prospective, open-label, phase II, multicenter exploratory clinical study. Eligible female patients aged 18-75 years with stage II-III HER2-positive breast cancer will receive 4 cycles of SHR-A1811 (4.8 mg/kg…
- Trial name
- NCT07787338
- Testing
- SHR-A1811, THPy
- Where
- China
- Volunteers
- 80 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Female Breast Cancer Patients, Histopathologically Confirmed Advanced HR +/HER2-invasive Breast Cancer
Adebrelimab Combined With Fluzoparib in HRD-positive HR +/HER2- Advanced Breast Cancer
This is an open-label, single-arm, exploratory study planned to include 40 patients with HRD-positive HR +/HER2- advanced breast cancer treated with Adebrelimab in combination with fluzoparib.
- Conditions
- Female Breast Cancer Patients, Histopathologically Confirmed Advanced HR +/HER2-invasive Breast Cancer, HRD Positive Advanced Breast Cancer
- Trial name
- NCT06254066
- Testing
- Adebrelimab plus Fluzoparib
- Volunteers
- 40 people
- Sponsor
- Zhejiang Cancer Hospital
Breast Cancer, Ovarian Cancer
Study of RGT-490 in Patients With PIK3CA-Mutated Advanced Solid Tumors
This is a phase 1/1b, open-label, multicenter study consisting of sequential parts designed to evaluate the safety, tolerability, and effects pharmacokinetic (PK) profile, and antitumor activity of RGT-490, an investigational…
- Conditions
- Breast Cancer, Ovarian Cancer, Endometrial Cancer, PIK3CA Mutation
- Trial name
- NCT07524322
- Testing
- RGT-490
- Where
- 6 sites in United States
- Volunteers
- 63 people
- Sponsor
- Regor Pharmaceuticals Inc.
Anatomic Stage IV Breast Cancer AJCC v8, Estrogen-receptor-positive Breast Cancer
Adaptive Therapy With Capecitabine for Treatment of Metastatic ER Positive, HER2 Negative Breast Cancer
This phase II trial evaluates the effect of capecitabine on tumor response using imaging and tumor markers to adjust dose (adaptive therapy) in patients with estrogen receptor (ER) positive, HER2 negative breast cancer that has…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Estrogen-receptor-positive Breast Cancer, Metastatic HER2-Negative Breast Carcinoma, Metastatic Breast Cancer
- Trial name
- NCT06525766
- Testing
- Biospecimen Collection, Bone Scan, Capecitabine
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Mayo Clinic
Breast Cancer
Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have…
- Trial name
- FLAMINGO-01 (NCT05232916)
- Testing
- GLSI-100
- Where
- 179 sites in United States, Belgium and 8 more
- Volunteers
- 2,250 people
- Sponsor
- Greenwich LifeSciences, Inc.
HR+/HER2- Early Breast Cancer
Patient Relevant Outcomes Improvement Program in High Risk Hormone Receptor Positive (HR+) Breast Cancer
The goal of this observational study is to evaluate how persistently patients with high-risk early breast cancer take abemaciclib 6 months after therapy start.
- Trial name
- PROSPER (NCT07531693)
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Institut fuer Frauengesundheit
Breast Cancer Stage I
Adjuvant Pyrotinib and Capecitabine For HER2 Positive Micro Invasive Breast Cancer
For patients with HER2-positive early-stage breast cancer, NCCN guidelines recommend chemotherapy plus targeted therapy as the standard adjuvant treatment for patients with tumors larger than 1 cm or lymph node-positive.
- Trial name
- NCT05861271
- Testing
- Capecitabine，Pyrotinib
- Where
- China
- Volunteers
- 1,008 people
- Sponsor
- Fudan University
Breast Cancer
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2…
- Trial name
- NCT06757634
- Testing
- Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole
- Where
- 239 sites in United States, Argentina and 23 more
- Volunteers
- 1,180 people
- Sponsor
- Celcuity Inc
Breast Neoplasm, Breast Cancer
SNF Platform Study of HR+/ HER2-advanced Breast Cancer
The purpose of this study is to establish a prospective, multi-center platform research based on clinical subtypes to explore precision therapy in patients hormone-receptor-positive HER2-negative advanced breast cancer who had…
- Conditions
- Breast Neoplasm, Breast Cancer, Hormone Receptor Positive Tumor, HER2-negative Breast Cancer
- Trial name
- NCT05594095
- Testing
- PIK3CA inhibitor, AKT inhibitor, Carrelizumab
- Where
- China
- Volunteers
- 620 people
- Sponsor
- Fudan University
Breast Cancer
A Real-World Study of Inavolisib in Patients With HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced Breast Cancer
A Multicenter, Observational Study on the Real-World Effectiveness and Safety of inavolisib Combined with Endocrine Therapy With or Without a CDK4/6 Inhibitor in Patients with HR-Positive/HER2-Negative, PIK3CA-Mutated Advanced…
- Trial name
- NCT07543250
- Testing
- Inavolisib in Combination With ET, Inavolisib in Combination With ET+CDK4/6i
- Volunteers
- 100 people
- Sponsor
- xuliang
Breast Cancer (Early Breast Cancer), Breast Cancer Survivors
Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer
EndoPredict is a genomic signature used to determine the 10-year risk of recurrence in early HR+/HER2- breast cancers classified as of intermediate risk according to conventional clinical and pathological criteria, and to guide…
- Conditions
- Breast Cancer (Early Breast Cancer), Breast Cancer Survivors, Breast Cancer Prognostic, Early Hormone Receptor-positive (HR-positive)
- Trial name
- SiMoSein (NCT07379918)
- Testing
- Endopredict test
- Where
- France
- Volunteers
- 1,000 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Advanced/Metastatic Breast Cancer, HER2-Positive Metastatic Breast Cancer
Dalpiciclib, Anti-HER2 Therapy, and Endocrine Therapy for Hormone-Receptor-Positive, HER2-Positive Metastatic Breast Cancer
Efficacy and Safety of Dalpiciclib Combined with Anti-HER2 Targeted Therapy and Endocrine Therapy as First-line Maintenance Treatment for Patients with Recurrent or Metastatic Hormone-Receptor-Positive, HER2-positive Breast…
- Trial name
- NCT07610720
- Testing
- Dalpiciclib, Trastuzumab (Herceptin), Pertuzumab
- Where
- China
- Volunteers
- 57 people
- Sponsor
- Sun Yat-sen University
Resectable HER2-positive Breast Cancer
A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer
This is a randomized, controlled, open-label, multicenter, Phase Ⅲ clinical study designed to compare the efficacy and safety of KN026 combined with HB1801 and chemotherapy versus trastuzumab combined with pertuzumab and…
- Trial name
- NCT07441460
- Testing
- KN026, HB1801, Trastuzumab
- Where
- China
- Volunteers
- 1,800 people
- Sponsor
- Shanghai JMT-Bio Inc.
Early Breast Cancer
This Clinical Trial is a Retrospective, Multicenter Cohort Study Evaluating the Real-world Characteristics and Risk of Disease Recurrence in Hormone Receptor-positive, HER2-negative Early Breast Cancer.
Primary objective: To describe event-free survival (EFS) in patients with stage I-III HR+/HER2- early breast cancer (EBC) who received curative surgery followed by systemic therapy.
- Trial name
- PRIORITY (NCT07309887)
- Where
- South Korea
- Volunteers
- 100,000 people
- Sponsor
- Samsung Medical Center
HER2-positive Breast Cancer
Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer
This is a Prospective, Single-Arm, Observational, Real-World Study. The purpose of this study is to evaluate the safety and efficacy of pyrotinib combined with trastuzumab and pertuzumab for maintenance therapy in HER2-positive…
- Trial name
- NCT07470203
- Testing
- Pyrotinib, Trastuzuma, Pertuzumab
- Volunteers
- 42 people
- Sponsor
- Peking University Cancer Hospital & Institute
Early Breast Cancer, Hormone Receptor Positive Tumor
Adherence to Aromatase Inhibitors ± Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer
Around 90% of breast cancer patients are diagnosed at an early stage and approximately 70% are hormone receptor-positive and HER2-negative (HR+/HER2-).
- Conditions
- Early Breast Cancer, Hormone Receptor Positive Tumor, HER2-negative Breast Cancer
- Trial name
- ONCO-Adher (NCT06650423)
- Where
- Slovenia
- Volunteers
- 319 people
- Sponsor
- Institute of Oncology Ljubljana
HER2 Positive Early Breast Cancer
EC-THP Versus TCbHP in HER2-positive Lymph Node Positive Early Breast Cancer
compare the efficacy and safety of TCbHP and EC-THP regimen in HER2-positive breast cancer patients
- Trial name
- NCT05883852
- Testing
- Docetaxel, carboplatin, Trastuzumab
- Where
- China
- Volunteers
- 1,406 people
- Sponsor
- Fudan University
Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer
Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis
This is a phase Ib/II study evaluating the safety and efficacy of zunsemetinib (ATI-450) with capecitabine in patients with hormone receptor-positive and HER2-negative (HR+/HER2-) metastatic breast cancer (MBC).
- Trial name
- NCT06374459
- Testing
- Zumsemetinib, Capecitabine, Zoledronic acid
- Where
- 3 sites in United States
- Volunteers
- 152 people
- Sponsor
- Washington University School of Medicine
Breast Cancer, HR Positive/HER2 Low Breast Cancer
Neoadjuvant Dalpiciclib + AI → SHR-A1811 for HR+/HER2-Low Breast Cancer
This is a phase II, single-arm, prospective exploratory study to evaluate the efficacy and safety of neoadjuvant dalpiciclib (a CDK4/6 inhibitor) plus an aromatase inhibitor (AI) followed by SHR-A1811 (an anti-HER2 antibody-drug…
- Trial name
- TD-DASHER-01 (NCT07618923)
- Testing
- Dalpiciclib 125mg, Aromatase Inhibitor, SHR-A1811
- Volunteers
- 20 people
- Sponsor
- Tang-Du Hospital
HER2-positive Breast Cancer, Advanced Breast Cancer
Prolonged Overnight Fasting and/or Exercise on Fatigue and Other Patient Reported Outcomes in Women With Hormone Receptor Positive Advanced Breast Cancer
The purpose of this study is to test whether four different supportive care programs can reduce fatigue in women with advanced or metastatic breast cancer who are receiving a medication called a CDK4/6 inhibitor (palbociclib…
- Trial name
- FastER (NCT06123988)
- Testing
- Prolonged Overnight Fasting, Moderate-Intensity Exercise, General Health Education Sessions
- Where
- 3 sites in United States
- Volunteers
- 260 people
- Sponsor
- University of Miami