Clinical trials: HER2/Neu Positive
Malignant Neoplasm of Breast
Comparing Efficacy and Safety of AryoGen Pharmed Biosimilar Trastuzumab (AryoTrust) Versus Herceptin® in Breast Cancer
This is A Phase III, randomized, two-armed, patient-outcome assessor-data analyzer blinded, parallel active controlled non-Inferiority clinical trial study to evaluate efficacy and safety of AryoTrust (Aryogen Trastuzumab in…
- Trial name
- NCT03425656
- Testing
- Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide
- Where
- 19 sites in Iran
- Volunteers
- 108 people
- Sponsor
- AryoGen Pharmed Co.
Advanced or Metastatic Breast Cancer
MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer
The main purpose of this open-label, dose-escalation, phase Ib study is to identify the appropriate dose of MEN1611 to be used in combination with Trastuzumab with/without Fulvestrant for the treatment of advanced or metastatic…
- Trial name
- B-PRECISE-01 (NCT03767335)
- Testing
- MEN1611, Trastuzumab, Fulvestrant
- Where
- 27 sites in United States, Belgium and 4 more
- Volunteers
- 62 people
- Sponsor
- Menarini Group
Breast Cancer
A Study to Evaluate the Efficacy and Safety of Herceptin® (Trastuzumab) in Combination With Arimidex® (Anastrozole) an Aromatase Inhibitor Compared to Arimidex® Alone in Patients With Metastatic Breast Cancer
This 2 arm study assessed the safety and efficacy of adding intravenous trastuzumab (Herceptin®) to daily oral anastrozole (Arimidex®) tablets as first- and second-line treatment in postmenopausal patients with human epidermal…
- Trial name
- NCT00022672
- Testing
- trastuzumab (Herceptin®), anastrazole (Arimidex®)
- Where
- 132 sites in United States, Australia and 24 more
- Volunteers
- 208 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
T-DM1 and Non-pegylated Liposomal Doxorubicin in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
The primary goal is to determine the maximum tolerated dose (MTD) of the combination of T-DM1 and non-pegylated liposomal doxorubicin in metastatic breast cancer (mBC) patients previously treated with taxanes and…
- Trial name
- THELMA (NCT02562378)
- Testing
- Trastuzumab and non-pegylated liposomal doxorubicin
- Where
- 4 sites in France, Spain
- Volunteers
- 15 people
- Sponsor
- MedSIR
Early Breast Cancer (Phase 2), Advanced Breast Cancer (Phase 1b)
Pre-Operative Study of PF-4691502 With Letrozole Compared To Letrozole Alone In Patients With Early Breast Cancer
PF-04691502 is an inhibitor of PI3K and mTOR kinase. Published data support the hypothesis that a PI3K/mTOR antagonist in combination with letrozole might mitigate the intrinsic or acquired resistance to hormonal therapy and…
- Trial name
- NCT01430585
- Testing
- PF-04691502, PF-04691502 in combination with Letrozole, Letrozole
- Where
- 5 sites in Belgium, Italy and 2 more
- Volunteers
- 14 people
- Sponsor
- Pfizer
Solid Cancers
A Study to Evaluate Corrected QT Interval and Drug-Drug Interaction of Trastuzumab on Carboplatin in the Presence of Docetaxel in Patients With HER2-Positive Metastatic or Locally Advanced Inoperable Cancer
This Phase Ib, multicenter, single-arm, open-label study is designed to evaluate the effect of trastuzumab on QTcF interval and to characterize the effects of trastuzumab on carboplatin pharmacokinetics in patients with…
- Trial name
- NCT00927589
- Testing
- carboplatin, docetaxel, trastuzumab
- Where
- 20 sites in United States
- Volunteers
- 59 people
- Sponsor
- Genentech, Inc.
Breast Cancer
Phase 2 Window Study of SAR439859 (Amcenestrant) Versus Letrozole in Post-menopausal Patients With ER+, HER2- Pre-operative Post-menopausal Primary Breast Cancer
Primary Objective: To determine whether amcenestrant given at 2 different doses improved the antiproliferative activity when compared to letrozole.
- Trial name
- AMEERA-4 (NCT04191382)
- Testing
- Amcenestrant (SAR439859), Letrozole
- Where
- 32 sites in United States, Belgium and 7 more
- Volunteers
- 105 people
- Sponsor
- Sanofi
Breast Cancer, Breast Cancer - Female
TEEL Study- Phase 1 Tamoxifen and Ribociclib (LEE011) in Advanced ER+ (HER2 Negative) Breast Cancer
The purpose of this study is to find out if the investigational drug Ribociclib (LEE011), when taken with standard treatment (Tamoxifen +/- Goserelin) is safe and has beneficial effects in pre-menopausal and post-menopausal women…
- Conditions
- Breast Cancer, Breast Cancer - Female, Breast Cancer - Male
- Trial name
- NCT02586675
- Testing
- Tamoxifen, Ribociclib, Goserelin
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Breast Cancer
Safety and Efficacy Study of Sapanisertib in Combination With Exemestane or Fulvestrant in Postmenopausal Women With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Metastatic Breast Cancer
This is a phase 1b/2 study of the safety and efficacy of sapanisertib (MLN0128) in combination with exemestane or fulvestrant therapy in women with estrogen receptor positive/human epidermal growth factor receptor 2 negative…
- Trial name
- NCT02049957
- Testing
- Sapanisertib, Fulvestrant, Exemestane
- Where
- 40 sites in United States, Belgium and 1 more
- Volunteers
- 118 people
- Sponsor
- Calithera Biosciences, Inc
Breast Cancer
S0221 Adjuvant Doxorubicin, Cyclophosphamide, and Paclitaxel in Treating Patients With Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die.
- Trial name
- NCT00070564
- Testing
- pegfilgrastim, AC regimen, cyclophosphamide
- Where
- 542 sites in United States, Canada and 1 more
- Volunteers
- 3,294 people
- Sponsor
- SWOG Cancer Research Network
Breast Cancer
Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
- Trial name
- TavIx (NCT00630032)
- Testing
- cyclophosphamide, Docetaxel, epirubicin hydrochloride
- Where
- 86 sites in United States, Belgium and 1 more
- Volunteers
- 762 people
- Sponsor
- UNICANCER
Breast Cancer
Adj TC + Herceptin Early Stage Breast Cancer
The purpose of this research study is to find out what effects (good and bad) docetaxel/cyclophosphamide (brand names: Taxotere and Cytoxan, or TC) plus trastuzumab (brand name: Herceptin, or H) has HER2+ breast cancer.
- Trial name
- NCT00493649
- Testing
- Taxotere, Cytoxan, Herceptin
- Where
- 69 sites in United States
- Volunteers
- 493 people
- Sponsor
- US Oncology Research
Breast Cancer
Implantable Microdevice for In Vivo Drug Sensitivity Testing in Patients With Early Stage, HER2-Positive or Triple Negative Breast Cancer
The purpose of this study is to test the safety and feasibility of placing and removing a small device that contains anti-cancer drugs in a breast tumor of patients who plan on having breast surgery without treatment prior or…
- Trial name
- NCT02521363
- Testing
- KIBUR MICRODEVICE, anthracycline and taxane based chemotherapy
- Where
- 6 sites in United States
- Volunteers
- 11 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Adenocarcinoma Gastric Stage IV With Metastases, Adenocarcinoma - GEJ
DS-8201a in HER2-positive Gastric Cancer That Cannot Be Surgically Removed or Has Spread (DESTINY-Gastric02)
This study will find out if trastuzumab deruxtecan is safe and works for participants with gastric or gastroesophageal junction cancer.
- Trial name
- NCT04014075
- Testing
- Trastuzumab deruxtecan
- Where
- 37 sites in United States, Belgium and 3 more
- Volunteers
- 79 people
- Sponsor
- Daiichi Sankyo
Gastric Cancer, Gastroesophageal Junction Cancer
Phase II Study of Ramucirumab With Chemotherapy in Patients With Metastatic Gastroesophageal Junction and Gastric Cancer
The purpose of this study is to compare any good and bad effects of using ramucirumab along with the usual trastuzumab and chemotherapy to using the usual chemotherapy and trastuzumab alone.
- Trial name
- NCT02726399
- Testing
- Ramucirumab, Trastuzumab, Capecitabine
- Where
- 6 sites in United States
- Volunteers
- 7 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
HER2 Positive Breast Cancer
A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer
This trial studies how well the drug tucatinib works when given with trastuzumab deruxtecan (T-DXd). It will also look at what side effects happen when these drugs are given together.
- Trial name
- HER2CLIMB-04 (NCT04539938)
- Testing
- tucatinib, trastuzumab deruxtecan
- Where
- 140 sites in United States
- Volunteers
- 70 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma
Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer
This randomized phase III clinical trial studies how well tamoxifen citrate, anastrozole, letrozole, or exemestane with or without chemotherapy work in treating patients with breast cancer that has spread from where it began in…
- Conditions
- Breast Ductal Carcinoma In Situ, Invasive Breast Carcinoma, Multicentric Breast Carcinoma, Multifocal Breast Carcinoma
- Trial name
- NCT01272037
- Testing
- Anastrozole, Exemestane, Laboratory Biomarker Analysis
- Where
- 1,568 sites in United States, Canada and 8 more
- Volunteers
- 5,018 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
A Study of Pertuzumab and Trastuzumab Subcutaneous (SC) Treatment in Combination With a Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
This open-label, multicenter, Phase IIIb study will assess the safety, tolerability and efficacy of a combination therapy of intravenous (IV) pertuzumab (Perjeta), trastuzumab (Herceptin) SC, and taxane chemotherapy (docetaxel…
- Trial name
- SAPPHIRE (NCT02019277)
- Testing
- Docetaxel, Nab-paclitaxel, Paclitaxel
- Where
- 13 sites in Australia
- Volunteers
- 50 people
- Sponsor
- Hoffmann-La Roche
Gastric Cancer
A Study of Trastuzumab Emtansine Versus Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer
This multicenter, randomized, adaptive Phase II/III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) compared to standard taxane (docetaxel or paclitaxel) treatment in participants with human epidermal…
- Trial name
- NCT01641939
- Testing
- Taxane, trastuzumab emtansine
- Where
- 148 sites in United States, Argentina and 26 more
- Volunteers
- 415 people
- Sponsor
- Hoffmann-La Roche
Neoplasms, Gastrointestinal Tract
LOGiC - Lapatinib Optimization Study in ErbB2 (HER2) Positive Gastric Cancer: A Phase III Global, Blinded Study Designed to Evaluate Clinical Endpoints and Safety of Chemotherapy Plus Lapatinib
This was an international multi-center trial that enrolled patients with locally advanced, unresectable, or metastatic gastric, esophageal, or gastro-esophageal junction cancer whose tumors had amplification of the ErbB2 (HER2)…
- Trial name
- NCT00680901
- Testing
- Lapatinib, Capecitabine, Oxaliplatin
- Where
- 183 sites in United States, Argentina and 21 more
- Volunteers
- 545 people
- Sponsor
- Novartis Pharmaceuticals