Clinical trials: Her2 Positive Metastatic Breast Cancer
Breast Cancer Stage IV
Trastuzumab Deruxtecan in First-Line HER2-Positive Metastatic Breast Cancer With Proactive Toxicity Management
This is an open-label, single arm, non-randomized, multicenter, phase 2 study assessing the efficacy and safety of T-DXd as first-line treatment in HER2-positive advanced/metastatic BC patients (N=300).
- Trial name
- TOP-REAL (NCT07371585)
- Testing
- Digital Health Tools, T-DXd, Pertuzumab
- Where
- 27 sites in France, Germany and 1 more
- Volunteers
- 300 people
- Sponsor
- SOLTI Breast Cancer Research Group
Breast Cancer
Trastuzumab in Treating Women With Metastatic Breast Cancer
RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
- Trial name
- NCT00896376
- Testing
- trastuzumab, laboratory biomarker analysis, pharmacological study
- Where
- France
- Volunteers
- 49 people
- Sponsor
- Centre Antoine Lacassagne
HER2 Positive Metastatic Breast Cancer
A Study of Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+Metastatic Breast Cancer Who Have Prior Received Anthracyclin, Taxane or Trastuzumab
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized, multi-center, multinational, open-label, active-controlled, parallel design study of the combination of…
- Trial name
- NCT02422199
- Testing
- pyrotinib, Lapatinib, capecitabine
- Where
- 2 sites in China
- Volunteers
- 128 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer
Real-World Data on First-line Treatment of Hormone Receptor-positive, HER2-negative, Metastatic Breast Cancer in Brazil
This study aims to describe in detail the patient journey from diagnosis to the beginning of treatment and patterns of care of hormone receptor- positive, HER2-negative de novo or recurrent metastatic breast cancer between…
- Trial name
- BRAVE (NCT05034393)
- Where
- 15 sites in Brazil
- Volunteers
- 308 people
- Sponsor
- Latin American Cooperative Oncology Group
Breast Cancer Metastatic, HER2-positive Metastatic Breast Cancer
Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd
ICARUS-BREAST02 is an open-label, multicenter, phase 1b/2, platform study that aims to evaluate the safety, tolerability, and efficacy of HER3-DXd monotherapy and in combination with other anti-cancer agents in patients with ABC.
- Conditions
- Breast Cancer Metastatic, HER2-positive Metastatic Breast Cancer, HER2 Low Breast Carcinoma, Advanced Breast Cancer
- Trial name
- ICARUSBREAST02 (NCT06298084)
- Testing
- Patritumab deruxtecan, Olaparib
- Where
- France
- Volunteers
- 152 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Neoplasms, Breast
A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer
A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib, trastuzumab or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer (MBC).
- Trial name
- NCT01160211
- Testing
- Lapatinib, Trastuzumab, Aromatase Inhibitor
- Where
- 110 sites in United States, Argentina and 27 more
- Volunteers
- 369 people
- Sponsor
- Novartis Pharmaceuticals
ER-positive Breast Cancer, HER2-negative Breast Cancer
Onapristone and Fulvestrant for ER+ HER2- Metastatic Breast Cancer After Endocrine Therapy and CDK4/6 Inhibitors (The SMILE Study)
A phase II single-arm trial of onapristone in combination with fulvestrant for women and men with ER-positive, PgR-positive or negative and HER2-negative locally advanced or metastatic breast cancer after progression on aromatase…
- Conditions
- ER-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Cancer
- Trial name
- NCT04738292
- Testing
- Onapristone, Fulvestrant
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- University of Wisconsin, Madison
Breast Cancer
A Study of Trastuzumab Emtansine in Comparison With Treatment of Physician's Choice in Participants With HER2-positive Breast Cancer Who Have Received at Least Two Prior Regimens of HER2-directed Therapy
This randomized, multicenter, 2-arm, open-label study (TH3RESA) will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) in comparison with treatment of the physician's choice in participants with metastatic or…
- Trial name
- TH3RESA (NCT01419197)
- Testing
- Trastuzumab emtansine, Treatment of physician's choice
- Where
- 184 sites in United States, Australia and 20 more
- Volunteers
- 602 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study on the Efficacy and Safety of IPyC for HER2+ MBC
Between July 2020 and August 2024, 301 HER2-positive MBC patients from five tertiary centers received the regimen until disease progression or unacceptable toxicity.
- Trial name
- NCT06990347
- Testing
- Inetetamab and Pyrotinib Combined with Chemotherapy
- Where
- China
- Volunteers
- 301 people
- Sponsor
- Fujian Medical University
Cancer
Continued HER2 Suppression With Lapatinib Plus Trastuzumab Versus Trastuzumab Alone
This was a randomized, open-label, multi-center Phase III study evaluating the efficacy and safety of lapatinib in combination with trastuzumab versus trastuzumab alone as continued HER2 suppression therapy in women with…
- Trial name
- NCT00968968
- Testing
- Lapatinib, Trastuzumab
- Where
- 116 sites in United States, Canada
- Volunteers
- 37 people
- Sponsor
- Novartis Pharmaceuticals
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
Breast Cancer Metastatic, Locally Advanced Breast Cancer (LABC)
A Study to Assess CLBR001+ABBV-461 in Subjects With Locally Advanced or Metastatic Breast Cancer
The goal of this clinical trial is to evaluate CLBR001 and ABBV-461 as a treatment for patients with locally advanced or metastatic breast cancer.
- Conditions
- Breast Cancer Metastatic, Locally Advanced Breast Cancer (LABC), Malignant Neoplasm of Breast, Triple Negative Breast Cancer (TNBC)
- Trial name
- NCT06878248
- Testing
- Two Component Product CLBR001 + ABBV-461
- Where
- 5 sites in United States
- Volunteers
- 10 people
- Sponsor
- Calibr, a division of Scripps Research
Breast Cancer, Breast Carcinoma
A Study to Describe the Breast Cancer Patient Population, Treatment, and Results in Indian Patients Receiving Combinations of the Medicines Called Palbociclib for Advanced Breast Cancer
The purpose of this clinical study is to describe the patient population, breast cancer treatment, and breast cancer treatment results of adult female patients who have received palbociclib combination treatments for advanced or…
- Conditions
- Breast Cancer, Breast Carcinoma, Breast Neoplasms, Breast Tumors
- Trial name
- NCT05584644
- Testing
- Palbociclib plus hormonal treatment - first line treatment, Palbociclib plus hormonal treatment - second line treatment
- Where
- 6 sites in India
- Volunteers
- 150 people
- Sponsor
- Pfizer
Breast Neoplasms
A Study of Allogenic Natural Killer Cells in Combination With Trastuzumab and Pertuzumab in Adult Patients With Refractory Metastatic Her2 Positive Breast Cancer. NK-ACT-BC_2020
Breast cancer is the second most common invasive malignancy and the leading cause of cancer-related mortality in women. Overexpression of human epidermal growth factor receptor 2 (HER2) is observed in approximately 20% of breast…
- Trial name
- NCT05385705
- Testing
- Cyclophosphamide, Trastuzumab, Pertuzumab
- Where
- 2 sites in Spain
- Volunteers
- 2 people
- Sponsor
- Vall d'Hebron Institute of Oncology
Metastatic Breast Cancer
Study to Evaluate the Efficacy and Safety of SHR6390 Combined With Pyrotinib in HER2+ Advanced Breast Cancer
The main purpose of this study was to observe the efficacy and safety of treatment with pyrotinib and CDK4/6 inhibitor SHR6390 for HER2-positive metastatic breast cancer.
- Trial name
- DAP-Her-01 (NCT04293276)
- Testing
- Pyrotinib, SHR6390
- Where
- China
- Volunteers
- 41 people
- Sponsor
- Henan Cancer Hospital
Breast Cancer
Combination Study of BMS-754807 and Herceptin® in Patients With Advanced or Metastatic Her-2-positive Breast Cancer
This is a Phase I/II study to evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics following daily oral doses of 50 to 200 mg of BMS-754807 in combination with trastuzumab (Herceptin®) in subjects with…
- Trial name
- NCT00788333
- Testing
- BMS-754807, trastuzumab (Herceptin®)
- Where
- 9 sites in Australia, Belgium and 3 more
- Volunteers
- 40 people
- Sponsor
- Bristol-Myers Squibb
Metastatic Breast Cancer
A Study of Abemaciclib (LY2835219) in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer
The reason for this study is to compare the efficacy of abemaciclib, in combination with fulvestrant, to that of physician's choice of chemotherapy in women with hormone receptor-positive (HR+), human epidermal growth factor…
- Trial name
- NCT04031885
- Testing
- Abemaciclib, Fulvestrant, Standard Chemotherapy
- Where
- 61 sites in United States, Puerto Rico
- Volunteers
- 4 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
Study of Poziotinib in Participants With HER2-Positive Metastatic Breast Cancer
The purpose of this study is to establish the dose regimen and evaluate the preliminary efficacy and the safety/tolerability of poziotinib in participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic…
- Trial name
- NCT02659514
- Testing
- Poziotinib
- Where
- 35 sites in United States
- Volunteers
- 67 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Metastatic Breast Cancer, Breast Cancer Stage I
A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
This is a Study to Evaluate the Efficacy and Safety of Multiple Combination Therapies with FWD1802 in Subjects with ER-positive/HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer
- Conditions
- Metastatic Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II, Locally Advanced Breast Cancer (LABC)
- Trial name
- NCT07002177
- Testing
- FWD1802, Palbociclib 125mg, Ribociclib 200Mg Oral Tablet
- Where
- China
- Volunteers
- 196 people
- Sponsor
- Forward Pharmaceuticals Co., Ltd.
Metastases, Brain
Lapatinib Plus Capecitabine Versus Trastuzumab Plus Capecitabine in ErbB2 (HER2) Positive Metastatic Breast Cancer
This open label study was designed to evaluate Lapatinib effect on incidence of brain metastases in ErbB2 (HER2) positive metastatic breast cancer patients exposed to prior taxanes or anthracyclines.
- Trial name
- NCT00820222
- Testing
- capecitabine, lapatinib, trastuzumab
- Where
- 164 sites in United States, Belgium and 12 more
- Volunteers
- 540 people
- Sponsor
- Novartis Pharmaceuticals