Clinical trials: Early or Locally Advanced HER2-positive Breast Cancer
HER2-positive Early Breast Cancer
A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer
The study will compare PK, efficacy, safety, and immunogenicity of SIBP-01 (Trastuzumab Biosimilar) in combination with Docetaxel and Carboplatin versus Herceptin® (CN-Trastuzumab) approved in the CN in combination with Docetaxel…
- Trial name
- NCT03989037
- Testing
- SIBP-01, Herceptin, Docetaxel
- Where
- China
- Volunteers
- 580 people
- Sponsor
- Shanghai Institute Of Biological Products
Breast Cancer
Trastuzumab Rezetecan vs Trastuzumab Deruxtecan in the Neoadjuvant Treatment of HER2 Positive Breast Cancer
This is a single-center, randomized, open-label, phase II interventional study. Eligible patients will be randomized 1:1 to receive either Trastuzumab-rezetecan (4.8 mg/kg Q3W) or T-DXd (5.4 mg/kg Q3W) for 8 neoadjuvant cycles.
- Trial name
- NCT07416253
- Testing
- Trastuzumab rezetecan, Trastuzumab deruxtecan
- Volunteers
- 68 people
- Sponsor
- Henan Cancer Hospital
Breast Cancer, HER2 Positive
Pyrotinib Maleate Tablets Combined With Albumin Paclitaxel and Trastuzumab for Her2-positive Breast Cancer
This study was designed to evaluate the efficacy and safety of pyrotinib combined with albumin paclitaxel and trastuzumab in the treatment of Her2-positive early or locally advanced breast cancer, and to explore RCB scores and…
- Conditions
- Breast Cancer, HER2 Positive, Combination Chemotherapy
- Trial name
- NCT04152057
- Testing
- Pyrotinib Maleate Tablets, Albumin Paclitaxel, Trastuzumab
- Where
- China
- Volunteers
- 20 people
- Sponsor
- West China Hospital
SHR-A1811, HER2-Postive Breast Cancer
SHR-A1811 Plus Pertuzumab as Neoadjuvant Therapy for Early or Locally Advanced HR-Positive HER2-Positive Breast Cancer: A Prospective, Open-Label, Phase II Study
Breast cancer is the most common malignancy in women, with approximately 20% classified as HER2-positive. Anti-HER2 blockade (trastuzumab plus pertuzumab) combined with chemotherapy constitutes the standard neoadjuvant regimen…
- Conditions
- SHR-A1811, HER2-Postive Breast Cancer, HR+ Breast Cancer, Early Breast Cancer
- Trial name
- NCT07307287
- Testing
- SHR- A1811
- Volunteers
- 30 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
Early-stage or Locally Advanced HER2-positive Breast Cancer
A Trial of SHR-A1811 Compared to Other Antitumor Therapies as Neoadjuvant Treatments in Early-stage or Locally Advanced HER2-positive Breast Cancer
This study is a multicenter, randomized, open-label, parallel Phase III clinical trial. 650 early-stage or locally advanced breast cancer participants will be enrolled and randomly assigned to SHR-A1811 monotherapy group (trial…
- Trial name
- NCT07196774
- Testing
- SHR-A1811 for Injection, Docetaxel injection, Trastuzumab Injection
- Where
- 2 sites in China
- Volunteers
- 740 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer
A Study of Evaluating The Effects Of Pyrotinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of pyrotinib in women with early stage high-risk breast cancer after adjuvant trastuzumab.
- Trial name
- NCT03980054
- Testing
- Pyrotinib
- Where
- China
- Volunteers
- 2,135 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer
SHR6390 Combined With Anastrozole for Preoperative Treatment of Breast Cancer.
The study is being conducted to assess effect of SHR6390 combined with anastrozole on proliferation of HR-positive HER2-negative breast cancer tumor cells before surgery.
- Trial name
- NCT04836520
- Testing
- SHR6390+anatrozole
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Tianjin Medical University Cancer Institute and Hospital
HER2-positive Breast Cancer
Neoadjuvant Study of Pyrotinib in Combination With Trastuzumab in Patients With HER2 Positive Breast Cancer
This is a randomised, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel versus placebo and trastuzumab plus docetaxel given as neoadjuvant…
- Trial name
- NCT03588091
- Testing
- Pyrotinib, Trastuzumab, Docetaxel
- Where
- 17 sites in China
- Volunteers
- 355 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
HER2-positive Breast Cancer
Clinical Study to Evaluate the Efficacy and Safety of TQB2440 Injection/Perjeta® Combined With Trastuzumab and Docetaxel in the Treatment of Patients With Early or Locally Advanced Breast Cancer.
This is a multicenter, randomized, double-blind, parallel-controlled Phase III study to evaluate the efficacy and safety of TQB2440 injection/Perjeta® combined with trastuzumab and docetaxel in patients with early or locally…
- Trial name
- NCT05985187
- Testing
- TQB2440 injection + Trastuzumab + Docetaxel, Perjeta + Trastuzumab + Docetaxel
- Where
- 6 sites in China
- Volunteers
- 412 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients
Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer
To compare the efficacy and safety of PERT-IJS (Proposed biosimilar Pertuzumab) plus trastuzumab and chemotherapy (carboplatin and docetaxel) versus EU-Perjeta plus trastuzumab and chemotherapy (carboplatin and docetaxel) in…
- Trial name
- NCT06038539
- Testing
- PERT-IJS plus trastuzumab, carboplatin and docetaxel, Perjeta plus trastuzumab, carboplatin and docetaxel
- Where
- India
- Volunteers
- 55 people
- Sponsor
- Biocon Biologics UK Ltd
Breast Cancer, Neoplasm, Breast
Neoadjuvant Study of Pyrotinib in Patients With HER2 Positive Breast Cancer
This is a randomized, double-blind multicenter Phase III study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus docetaxel and Carboplatin versus placebo and trastuzumab plus docetaxel and…
- Conditions
- Breast Cancer, Neoplasm, Breast, Breast Diseases
- Trial name
- NCT03756064
- Testing
- Pyrotinib, Trastuzumab, Docetaxel
- Where
- China
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Zhejiang Cancer Hospital
Breast Cancer
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
This study aims to evaluate the efficacy and safety of pyrotinib in combination with nab-paclitaxel or trastuzumab with nab-paclitaxel as neoadjuvant therapy in early stage or locally advanced HER2-positive breast cancer.
- Trial name
- NCT04066790
- Testing
- Pyrotinib, nab-Paclitaxel, Trastuzumab
- Where
- China
- Volunteers
- 12 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
HER2 Positive Breast Cancer
Neoadjuvant Study of Pyrotinib and Trastuzumab Plus Vinorelbine in Trastuzumab-refractory HER2-Positive Breast Cancer.
This study is a single-arm, prospective, open label clinical study for evaluating the efficacy and safety of neoadjuvant pyrotinib and trastuzumab plus Vinorelbine given as neoadjuvant treatment in Trastuzumab-refractory HER2…
- Trial name
- NCT03947242
- Testing
- Pyrotinib and Trastuzumab plus Vinorelbine
- Volunteers
- 48 people
- Sponsor
- Henan Cancer Hospital
Breast Cancer
ctDNA in HER2+ EBC Neoadjuvant Treatment
This study is a randomized, open-label, multicenter clinical study for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer, aiming to compare the peripheral blood ctDNA clearance of neoadjuvant…
- Trial name
- NCT07335081
- Testing
- pyrotinib, pertuzumab, trastuzumab
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Neoadjuvant Pyrotinib-to-pertuzumab in HER2+ eBC
This is a randomized, open-label, superiority, multicenter clinical trial for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer.
- Trial name
- NCT07797218
- Testing
- Docetaxel, Pyrotinib, Trastuzumab (Herceptin)
- Where
- China
- Volunteers
- 220 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
Breast Neoplasms
A Long-term Follow-up Study for Cardiac Safety in the Patients With HER2 (+) Breast Cancer Who Have Completed the SB3-G31-BC
A Long-term Follow-up Study for Cardiac Safety in the Patients with HER2 Positive Early or Locally Advanced Breast Cancer Who Have Completed the SB3-G31-BC
- Trial name
- NCT02771795
- Testing
- Herceptin (trastuzumab), SB3 (proposed trastuzumab biosimilar)
- Where
- 40 sites in Bulgaria, Czechia and 5 more
- Volunteers
- 538 people
- Sponsor
- Samsung Bioepis Co., Ltd.
Breast Cancer
Treatment of Breast Cancer With Trastuzumab + HS627/ Pertuzumab + Docetaxel
The trial included screening period (4 weeks) and treatment period (4 treatment cycles, at least 12 weeks).
- Trial name
- NCT04514419
- Testing
- HS627, Pertuzumab
- Where
- China
- Volunteers
- 408 people
- Sponsor
- BioRay Pharmaceutical Co., Ltd.
Metastatic Breast Cancer
Corrected QT Interval Effects of Trastuzumab Emtansine (T-DM1) in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer and the Safety and Tolerability of Combined T-DM1 and Pertuzumab in Patients With Early Disease Progression
This is a multicenter, open-label, single-arm Phase II study designed to evaluate the effect of T-DM1 on the duration of corrected QT (QTc) interval in patients with HER2-positive locally advanced or metastatic breast cancer and…
- Trial name
- NCT00943670
- Testing
- pertuzumab, Trastuzumab emtansine [Kadcyla]
- Volunteers
- 51 people
- Sponsor
- Genentech, Inc.
Breast Cancer
A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer
This 3 arm study will assess the tolerability, safety and efficacy of 3 neoadjuvant treatment regimens in participants with locally advanced, inflammatory or early stage human epidermal growth factor receptor 2 (HER2)-positive…
- Trial name
- NCT00976989
- Testing
- Pertuzumab, Trastuzumab, FEC
- Where
- 55 sites in Bosnia and Herzegovina, Brazil and 18 more
- Volunteers
- 225 people
- Sponsor
- Hoffmann-La Roche
Early Breast Cancer, Locally Advanced Breast Cancer
A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer
This is a Phase IIIb, multinational, multicenter, randomized, open-label study to evaluate patient preference of the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous use (PH FDC SC) administration in the home…
- Conditions
- Early Breast Cancer, Locally Advanced Breast Cancer, Inflammatory Breast Cancer
- Trial name
- ProHer (NCT05415215)
- Testing
- Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC), Pertuzumab IV, Trastuzumab IV
- Where
- 45 sites in Argentina, Bosnia and Herzegovina and 15 more
- Volunteers
- 346 people
- Sponsor
- Hoffmann-La Roche