Clinical trials: HER2-Positive Breast Carcinoma, open to volunteers
Advanced or Metastatic Breast Cancer
A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer
This is a first in human dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of AND019 in postmenopausal women with…
- Trial name
- NCT05187832
- Testing
- AND019 PO QD
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Kind Pharmaceuticals LLC
HER2-positive Breast Cancer, Breast Cancer
A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer
- Trial name
- EmpowHER 208 (NCT07102381)
- Testing
- Zanidatamab, Paclitaxel, Docetaxel
- Where
- 53 sites in United States, Germany and 2 more
- Volunteers
- 125 people
- Sponsor
- Jazz Pharmaceuticals
HER2 Positive Breast Cancer, Pyrotinib Treatment
The Impact of Intelligent Patient Management Model on Medication Adherence of Pyrotinib Compared to Traditional Patient Management Model: a Prospective, Multicenter, Randomized Controlled Clinical Study
This is a prospective, multicenter, randomized controlled clinical study to evaluate the effect of using intelligent patient management system on medication adherence of HER2 positive breast cancer patients receiving pyrotinib…
- Trial name
- any (NCT06958627)
- Testing
- pyrotinib
- Where
- China
- Volunteers
- 964 people, healthy volunteers welcome
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Advanced Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer
A Phase II Study of Zongertinib Plus Fulvestrant in Participants With HR-positive/HER2-negative Advanced Breast Cancer Harboring HER2 Mutations.
An international, multicenter, two-stage optimal Simon's design, single-arm phase II clinical trial to evaluate zongertinib plus fulvestrant combination therapy in participants with hormone receptor-positive/HER2-negative…
- Conditions
- Advanced Breast Cancer, Hormone Receptor Positive / HER2-negative Breast Cancer, HER2 Mutation
- Trial name
- AGATHA (NCT07619066)
- Testing
- Zongertinib (BI 1810631), Fulvestrant
- Volunteers
- 25 people
- Sponsor
- MedSIR
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
SHR-A1811 Plus Pertuzumab in the Neoadjuvant Treatment of HER2 Positive BC
The goal of this clinical trial is to evaluate the efficacy and safety of SHR-A1811 plus pertuzumab in combination with or without albumin-paclitaxel neoadjuvant therapy for early or locally advanced HER2-positive breast cancer.
- Trial name
- NCT06927180
- Testing
- SHR-A1811, Pertuzumab, Albumin-Paclitaxel
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Henan Cancer Hospital
HER2-positive Breast Cancer
De-escalation Neoadjuvant Therapy for Intermediate Risk HER2-positive Early Breast
High pathological complete response (pCR) rates are seen using different neoadjuvant chemotherapy schedules with trastuzumab and pertuzumab in HER2-positive stage II-III breast cancer patients.
- Trial name
- neoDIRHP (NCT07748260)
- Testing
- THP×4 Q3W (n=296) (Investigator-selected taxane* + Trastuzumab IV 6 mg/kg, loading dose 8 mg/kg + Pertuzumab IV 420 mg, loading dose 840mg), THP×6 Q3W (n=296) (Investigator-selected taxane* + Trastuzumab IV 6 mg/kg, loading dose 8 mg/kg + Pertuzumab IV 420 mg, loading dose 840mg)
- Volunteers
- 592 people
- Sponsor
- Guangdong Provincial People's Hospital
HR Positive/HER-2 Negative Breast Cancer
Adding Capivasertib to Standard Treatment in HR Positive, HER2 Negative Metastatic Breast Cancer Based on ctDNA Testing
The purpose of this research is to see if adding the investigational targeted drug capivasertib to standard endocrine therapy (hormone-blocking treatment) combined with a medicine that slows cancer cell growth can improve…
- Trial name
- MONITOR (NCT07802626)
- Testing
- NSAI + CDK4/6i, NSAI + CDK4/6i + Capivasertib, Fulvestrant + CDK4/6i + Capivasertib
- Volunteers
- 1,084 people
- Sponsor
- SWOG Cancer Research Network
HER2 + Breast Cancer
A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of HLX319 vs. EU-Phesgo® in the Neoadjuvant Therapy of HER2-Positive Early or Locally Advanced Breast Cancer
This is a study to compare the similarity in Pharmacokinetics (PK) profile of HLX319 vs. EU-Phesgo® in patients with HER2-positive early or locally advanced breast cancer .
- Trial name
- NCT07601620
- Testing
- HLX319, EU-Phesgo®
- Volunteers
- 258 people
- Sponsor
- Shanghai Henlius Biotech
Breast Cancer, Metastastic Breast Cancer
Culmerciclib in HR+/HER2+ Advanced Breast Cancer
This is a phase II, multicenter, open-label, single-arm clinical study. The purpose of this study is to evaluate the efficacy and safety of culmerciclib combined with anti-HER2 targeted therapy and endocrine therapy as…
- Conditions
- Breast Cancer, Metastastic Breast Cancer, HER2+ Advanced Breast Cancer
- Trial name
- NCT07732491
- Testing
- Culmerciclib
- Where
- China
- Volunteers
- 35 people
- Sponsor
- Sun Yat-sen University
Breast Cancer, HER2-positive Breast Cancer
HER2 Vaccine for Locally Advanced Breast Cancer
The goal of this study is to test an investigational vaccine to activate the immune system to fight breast cancer.
- Trial name
- NCT06949410
- Testing
- HER2 Vaccine
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Pravin T.P Kaumaya
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, Metastatic Breast Cancer
Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer
This is a phase 2, open-label, singled-arm clinical trial determining efficacy of combination therapy with anastrozole, fulvestrant and abemaciclib in subjects with breast cancer.
- Conditions
- Breast Cancer, Metastatic Breast Cancer, Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer
- Trial name
- NCT05524584
- Testing
- Fulvestrant, Anastrozole, Abemaciclib
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, Irvine
HER2 Low Breast Carcinoma
A Study of SHR-A1811 as Neoadjuvant Treatment for Patients With HR-Positive, Low HER2 Expression Breast Cancer
HR-positive breast cancers accounts for about 50% to 60% of all breast cancer patients. Neoadjuvant Chemotherapy is the core treatment mode for this type of breast cancer, and endocrine therapy can be used in some low-risk…
- Trial name
- NCT05911958
- Testing
- SHR-A1811 for injection
- Where
- China
- Volunteers
- 66 people
- Sponsor
- Henan Cancer Hospital
Breast Cancer, Triple Negative Breast Cancer (TNBC)
Preoperative Chemotherapy, Pembrolizumab and Low or High Dose RADiation in an Expansion Cohort of Node(+), Triple Negative Breast Cancer
This is a prospective radiation dose-finding, phase 2 expansion study of the Triple Negative (TN) cohort of the multicenter randomized study P-RAD (A Randomized Study of Preoperative Chemotherapy, Pembrolizumab and No, Low or…
- Conditions
- Breast Cancer, Triple Negative Breast Cancer (TNBC), HER2-Negative Breast Carcinoma, Node-positive Breast Cancer
- Trial name
- P-RAD(+)TN-DCT (NCT07276880)
- Testing
- Neoadjuvant Pembrolizumab, low dose neoadjuvant boost, High dose neoadjuvant boost
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- UNC Lineberger Comprehensive Cancer Center
Breast Neoplasm Malignant Female
Omission of Local Therapies in Women Patients With HER2-positive or Triple-negative Breast Cancer
HER2-positive and Triple-negative are subtypes of breast cancer more sensitive to systemic therapies, where the complete pathological response rate may be higher than 50%.
- Trial name
- OLT (NCT06938724)
- Testing
- Omission of local therapies
- Where
- Italy
- Volunteers
- 152 people
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
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
Breast Cancer (Locally Advanced or Metastatic), HER2-positive Breast Cancer
Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and TNBC)
This study tests the safety and preliminary anti-tumor activity of an investigational dual-target chimeric antigen receptor natural killer (CAR-NK) cell therapy in adults with advanced breast cancer.
- Conditions
- Breast Cancer (Locally Advanced or Metastatic), HER2-positive Breast Cancer, Triple-Negative Breast Cancer (TNBC)
- Trial name
- DUAL-NK-BC (NCT07486089)
- Testing
- Dual-target CAR-NK cells (EB-DT-CAR-NK), Lymphodepleting chemotherapy, Supportive care
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Beijing Biotech
Metastatic Breast Cancer, HER2 + Breast Cancer
A First-in-Human Phase 1 Safety and Biodistribution of [177Lu]Lu-ABY-271 in Subjects With HER2-positive Metastatic Breast Cancer
This is a FiH phase 1, open-label, two-stage, randomized trial to assess the safety, tolerability, and biodistribution of [177Lu]Lu-ABY-271 in subjects with HER2 positive metastatic breast cancer.
- Trial name
- NCT07081555
- Testing
- [177Lu]Lu-ABY-271
- Where
- 3 sites in Sweden
- Volunteers
- 21 people
- Sponsor
- Affibody
HR+/HER2- Breast Cancer
Neoadjuvant Chemotherapy in Combination With Anlotinib and Benmelstobart for HR+/HER2- Breast Cancer (NEOTORCH-BREAST03)
Our center plans to conduct a prospective, single-arm exploratory clinical study to evaluate the efficacy and safety of neoadjuvant chemotherapy combined with Anlotinib and Benmelstobart in the treatment of HR+/HER2- breast…
- Trial name
- NCT06874933
- Testing
- Neoadjuvant Chemotherapy in Combination with Anlotinib and Benmelstobart
- Where
- 3 sites in China
- Volunteers
- 35 people
- Sponsor
- First Affiliated Hospital of Zhejiang University
Breast Cancer Early Stage Breast Cancer (Stage 1-3), HR Positive/HER2 Low Breast Cancer
Chemotherapy With or Without Adebrelimab and T-DXh as Neoadjuvant Therapy for HR+/HER2 Low Early Stage Breast Cancer
The goal of this clinical trial is to learn if add SHR-A1811 and/or Adebrelimab on standard chemotherapy could further improve the pCR rate in HR+/HER2 low early stage breast cancer patients.
- Trial name
- NCT07317778
- Testing
- SHR-A1811, Adebrelimab (PD-L1 inhibitor), Taxane Chemotherapy
- Where
- China
- Volunteers
- 249 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences