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
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.
HER-2 Positive Breast Cancer, Breast Cancer
T-DM1+Pertuzumab in Pre-OP Early-Stage HER2+ BRCA
This research study is studying a combination of drugs as a possible treatment for breast cancer that has tested positive for a protein called HER2.
- Conditions
- HER-2 Positive Breast Cancer, Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
- Trial name
- NCT02326974
- Testing
- T-DM1, Pertuzumab, Excision of tumor/mastectomy
- Where
- 4 sites in United States
- Volunteers
- 164 people
- Sponsor
- Dana-Farber Cancer Institute
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.
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
Breast Cancer, Estrogen Receptor Positive Tumor
To Reduce the Use of Chemotherapy in Postmenopausal Patients With ER-positive and HER2-positive Breast Cancer (TOUCH)
This is a phase II open-label, multicentre, randomized trial. The study assesses the treatment of postmenopausal patients with hormone receptor positive/HER2 positive early breast cancer with neoadjuvant palbociclib in…
- Conditions
- Breast Cancer, Estrogen Receptor Positive Tumor, HER2-positive Breast Cancer
- Trial name
- TOUCH (NCT03644186)
- Testing
- Paclitaxel, Trastuzumab, Pertuzumab
- Where
- 54 sites in Belgium, France and 2 more
- Volunteers
- 147 people
- Sponsor
- ETOP IBCSG Partners Foundation
Breast Cancer, Breast Cancer Female
Preoperative Stereotactic Ablative Body Radiotherapy (SABR) for Early-Stage Breast Cancer
This study involves a course of radiation to the tumor that is delivered BEFORE surgery. The type of radiation is called stereotactic ablative body radiation therapy (SABR).
- Conditions
- Breast Cancer, Breast Cancer Female, Breast Adenocarcinoma
- Trial name
- NCT03137693
- Testing
- Standard of Care Schedule Variation: SABR, Breast-conserving Surgery
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Breast Cancer
Carvedilol for the Prevention of Anthracycline/Anti-HER2 Therapy Associated Cardiotoxicity Among Women With HER2-Positive Breast Cancer Using Myocardial Strain Imaging for Early Risk Stratification
The purpose of this study is to find out the effects, good and/or bad, of a beta blocker (carvedilol) on heart function during treatment with anti-HER2 medication(s) including trastuzumab (Herceptin).
- Trial name
- NCT02177175
- Testing
- Carvedilol
- Where
- 2 sites in United States
- Volunteers
- 82 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
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
Estrogen Receptor Positive, HER2/Neu Negative
FLT PET in Measuring Treatment Response in Patients With Newly Diagnosed Estrogen Receptor-Positive, HER2-Negative Stage I-III Breast Cancer
This clinical trial studies fluorine F 18 fluorothymidine (FLT) positron emission tomography (PET) in measuring treatment response in patients with newly diagnosed estrogen receptor (ER)-positive, human epidermal growth factor…
- Conditions
- Estrogen Receptor Positive, HER2/Neu Negative, Male Breast Carcinoma, Stage IA Breast Cancer
- Trial name
- NCT01928186
- Testing
- Fluorothymidine F-18, Positron Emission Tomography, Laboratory Biomarker Analysis
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- University of Washington
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
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.
Breast Cancer, Breast Cancer, Early-Onset
Preoperative Window Opportunity Study With Giredestrant or Tamoxifen in Premenopausal Women With ER+/HER2[-] & Ki67≥10%
This study is a window of opportunity clinical trial to evaluate the efficacy of giredestrant (GDC-9545) or tamoxifen in estrogen receptor-positive (ER[+])/human epidermal growth factor receptor 2-negative (HER2[-]) primary…
- Trial name
- EMPRESS (NCT05659563)
- Testing
- Giredestrant, Tamoxifen
- Where
- 18 sites in France, Spain
- Volunteers
- 92 people
- Sponsor
- MedSIR
Locally Advanced Breast Cancer, Metastatic Breast Cancer
Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab
The goal of this national, multicenter single arm phase II clinical trial is to study the efficacy, safety and tolerability of the administration of Trastuzumab Deruxtecan (T-DXd) in HER2-positive locally advanced or metastatic…
- Trial name
- TRANSCENDER (NCT05744375)
- Testing
- Trastuzumab deruxtecan
- Where
- 19 sites in Spain
- Volunteers
- 2 people
- Sponsor
- Spanish Breast Cancer Research Group
HER2-positive Early Breast Cancer
A Two-Arm 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 Chinese Participants With HER2-Positive Early Breast Cancer
This study will evaluate the pharmacokinetics, efficacy, and safety of the pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) as compared with those of the pertuzumab intravenous (IV)…
- Trial name
- NCT04024462
- Testing
- Pertuzumab IV, Trastuzumab IV, Pertuzumab and Trastuzumab FDC SC
- Where
- 18 sites in China
- Volunteers
- 200 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer
This study is looking at whether Metformin, an agent that is commonly used to treat diabetes, can decrease or affect the ability of breast cancer cells to grow and whether Metformin will work with other therapies to keep cancer…
- Trial name
- NCT01101438
- Testing
- metformin hydrochloride
- Where
- 344 sites in United States, Canada and 2 more
- Volunteers
- 3,649 people
- Sponsor
- Canadian Cancer Trials Group
Breast Cancer
A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer.
This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer.
- Trial name
- NCT00545688
- Testing
- Herceptin, Docetaxel, Pertuzumab
- Where
- 77 sites in Australia, Austria and 16 more
- Volunteers
- 417 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study To Evaluate the Efficacy and Safety Of Atezolizumab or Placebo in Combination With Neoadjuvant Doxorubicin + Cyclophosphamide Followed By Paclitaxel + Trastuzumab + Pertuzumab In Early Her2-Positive Breast Cancer
This study (also known as IMpassion050) will evaluate the efficacy and safety of atezolizumab compared with placebo when given in combination with neoadjuvant dose-dense anthracycline (doxorubicin) + cyclophosphamide followed by…
- Trial name
- IMpassion050 (NCT03726879)
- Testing
- Atezolizumab, Doxorubicin, Cyclophosphamide
- Where
- 76 sites in United States, Brazil and 10 more
- Volunteers
- 454 people
- Sponsor
- Hoffmann-La Roche