Clinical trials: HER2-positive Early Breast Cancer
Breast Cancer
An Observational Study of the Mean Duration of Trastuzumab (Herceptin) Treatment in Participants With Early or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
This single arm observational study will assess the duration and safety of treatment with trastuzumab in routine clinical practice in participants with early or metastatic HER2-positive breast cancer.
- Trial name
- HERODOT (NCT01187381)
- Testing
- Trastuzumab
- Where
- Romania
- Volunteers
- 250 people
- Sponsor
- Hoffmann-La Roche
Early or Locally Advanced HER2-positive Breast Cancer
A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanced HER2-Positive Breast Cancer
This randomized, controlled, open-label, multicenter study will evaluate the safety and efficacy of KN026 in combination with HB1801 ± Carboplatin as neoadjuvant therapy in patients with early or locally advanced HER2-positive…
- Trial name
- Neo-Healer (NCT06747338)
- Testing
- KN026, HB1801, Pertuzumab
- Where
- China
- Volunteers
- 520 people
- Sponsor
- Shanghai JMT-Bio Inc.
Breast Cancer
An Indirect Treatment Comparison of the Effectiveness of Ribociclib Combined With Non-steroidal Aromatase Inhibitors vs. Tamoxifen for the Adjuvant Treatment of Premenopausal Women With Hormon Receptor-positive, HER2-negative Early Breast Cancer
The purpose of this indirect treatment comparison (ITC) was to generate comparative evidence on the effectiveness and safety in premenopausal women of ribociclib+Non-steroidal Aromatase Inhibitor (NSAI)+Ovarian Function…
- Trial name
- IRINA (NCT07072013)
- Testing
- ribociclib
- Where
- Germany
- Volunteers
- 1,937 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
An Observational Study of the Safety of Herceptin Given Subcutaneously in Patients With Early HER2-positive Breast Cancer
This non-interventional prospective study will assess the safety of Herceptin SC (subcutaneous administration) as used in routine clinical practice.
- Trial name
- NCT02286362
- Where
- 97 sites in France
- Volunteers
- 510 people
- Sponsor
- Hoffmann-La Roche
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
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.
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.
Breast Cancer
Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer
The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.
- Trial name
- ExteNET (NCT00878709)
- Testing
- neratinib
- Where
- 494 sites in United States, Australia and 38 more
- Volunteers
- 2,840 people
- Sponsor
- Puma Biotechnology, Inc.
Breast Cancer
A Study of Herceptin (Trastuzumab) in Combination With Avastin (Bevacizumab) and Sequential Xeloda (Capecitabine) or Docetaxel in Patients With HER2-Positive Locally Recurrent or Metastatic Breast Cancer
This single arm, open-label study will evaluate the safety and efficacy of Herceptin in combination with Avastin and sequential Xeloda in patients with locally recurrent or metastatic HER2-positive breast cancer after early…
- Trial name
- NCT00964704
- Testing
- bevacizumab [Avastin], capecitabine [Xeloda], docetaxel
- Sponsor
- Hoffmann-La Roche
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
Neoplasms, Breast
ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D
This was a four-arm (parallel group) randomized, open-label, multicenter Phase 3 study to investigate the use of a combination of Lapatinib and Trastuzumab, a sequence of Trastuzumab followed by Lapatinib, and Lapatinib alone…
- Trial name
- ALTTO (NCT00490139)
- Testing
- Lapatinib, Trastuzumab
- Where
- 924 sites in United States, Argentina and 42 more
- Volunteers
- 8,381 people
- Sponsor
- Novartis Pharmaceuticals
Early-stage HER2+ Breast Cancer
A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization
The main purpose of this study is to evaluate the impact of a decentralized treatment model on treatment adherence in participants with early-stage human epidermal growth factor receptor 2- positive (HER2+) breast cancer (BC).
- Trial name
- Close2HER (NCT07527741)
- Where
- 10 sites in Serbia
- Volunteers
- 100 people
- Sponsor
- Hoffmann-La Roche
Early Breast Cancer
A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04)
The current study will compare PK, efficacy, safety, and immunogenicity of PF-05280014 (Trastuzumab-Pfizer) in combination with Taxotere® and Carboplatin (Paraplatin) versus Herceptin® (Trastuzumab-EU) approved in the EU in…
- Trial name
- NCT02187744
- Testing
- PF-05280014, Taxotere®, Paraplatin®
- Where
- 52 sites in United States, Belarus and 8 more
- Volunteers
- 226 people
- Sponsor
- Pfizer
Breast Neoplasms, Breast Cancer
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Researchers are looking for new ways to treat triple-negative breast cancer (TNBC) and hormone receptor (HR) low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer.
- Trial name
- NCT06797635
- Testing
- Patritumab deruxtecan, Pembrolizumab, Paclitaxel
- Where
- 17 sites in United States, South Korea and 2 more
- Volunteers
- 372 people
- Sponsor
- Merck Sharp & Dohme LLC
Early Breast Cancer
A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer
This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC)…
- Trial name
- FeDeriCa (NCT03493854)
- Testing
- Cyclophosphamide, Doxorubicin, Docetaxel
- Where
- 107 sites in United States, Argentina and 17 more
- Volunteers
- 500 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Prospective Observational Study Evaluating Treatment Decision Impact of Prosigna® in Early Stage Breast Cancer Patients
This multicenter, prospectively designed study examines whether the Prosigna score influences physician and patient adjuvant treatment selection over and above currently used prognostic factors.
- Trial name
- NCT02625935
- Where
- 4 sites in United States
- Volunteers
- 206 people
- Sponsor
- NanoString Technologies, Inc.
HER2-positive Carcinoma of Breast
Efficacy and Safety Evaluating Study of CT-P6 in Her2 Positive Early Breast Cancer
This study will determine whether CT-P6 and Herceptin are equivalent in patients with early-stage breast cancer undergoing neoadjuvant chemotherapy.
- Trial name
- NCT02162667
- Testing
- Trastuzumab
- Where
- 98 sites in Argentina, Belarus and 20 more
- Volunteers
- 562 people
- Sponsor
- Celltrion
HER2-positive Breast Cancer, Early-stage Breast Cancer
Extension Study to Provide Adjuvant Treatment Following Neoadjuvant Treatment and Surgical Resection in Protocol TX05-03
This is an extension study to provide adjuvant treatment with single agent Herceptin or TX05 and assess continued safety and immunogenicity in subjects with HER2-positive early breast cancer following neoadjuvant treatment and…
- Conditions
- HER2-positive Breast Cancer, Early-stage Breast Cancer, Breast Cancer, Breast Neoplasms
- Trial name
- NCT04109391
- Testing
- TX05 (trastuzumab), Herceptin (trastuzumab)
- Where
- 86 sites in Belarus, Chile and 8 more
- Volunteers
- 338 people
- Sponsor
- Tanvex BioPharma USA, Inc.
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, Breast Neoplasms
A Study to Evaluate the Efficacy and Safety of HLX11 vs. EU-Perjeta® in the Neoadjuvant Therapy of HER2-Positive and HR-Negative Early-stage or Locally Advanced Breast Cancer
This is a phase III, double-blind, randomized, parallel-controlled, multicenter equivalence study to compare the efficacy and safety of pertuzumab biosimilar HLX11 vs.
- Conditions
- Breast Cancer, Breast Neoplasms, HER2-positive Breast Cancer
- Trial name
- NCT05346224
- Testing
- HLX11, EU-Perjeta®
- Where
- 79 sites in China, Hungary and 2 more
- Volunteers
- 900 people
- Sponsor
- Shanghai Henlius Biotech