Clinical trials: HER2 Positive Metastatic Breast Cancer
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
Metastatic HER2-Positive Breast Cancer
Gemcitabine, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer After Prior Trastuzumab/Pertuzumab, or Pertuzumab Based Therapy
The purpose of this study is to see if a combination of drugs can help to treat breast cancer. This is a Phase II study which will test whether this combination of drugs is effective and will provide further information on side…
- Trial name
- NCT02252887
- Testing
- Gemcitabine, Trastuzumab, Pertuzumab
- Where
- 5 sites in United States
- Volunteers
- 45 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Unresectable Breast Cancer, Metastatic Breast Cancer
HER-TEMPO - Real World Treatment-related Outcomes on T-DXd in Canada
Trastuzumab deruxtecan (T-DXd) has been studied in multiple global prospective DESTINY-Breast trials and has a marketing authorization from Health Canada for patients with HER2-positive metastatic breast cancer (mBC) and HER2-low…
- Conditions
- Unresectable Breast Cancer, Metastatic Breast Cancer, HER2-low Expressing Breast Cancer, HER2-positive Breast Cancer
- Trial name
- HER-TEMPO (NCT06386263)
- Testing
- Trastuzumab deruxtecan
- Where
- Canada
- Volunteers
- 22 people
- Sponsor
- AstraZeneca
Breast Cancer
A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer
This is a multicenter, open label, Phase 1b study in patients with mBC. This study will have a dose escalation to identify the maximum tolerated dose (MTD) of the combination of gedatolisib plus palbociclib/fulvestrant and…
- Trial name
- NCT02684032
- Testing
- Gedatolisib, Palbociclib, Letrozole
- Where
- 41 sites in United States
- Volunteers
- 141 people
- Sponsor
- Celcuity Inc
Advanced HER2-positive Breast Cancer or Gastric Cancer
Phase I Study LJM716 Combined With Trastuzumab in Patients With HER2 Overexpressing Metastatic Breast or Gastric Cancer
This is a multicenter, open-label, dose escalation, phase I study to estimate the Maximum Tolerated Dose (MTD) or a lower Recommended Dose for Expansion (RDE) of LJM716 in combination with trastuzumab in patients with Human…
- Trial name
- NCT01602406
- Testing
- LJM716, Trastuzumab
- Where
- 11 sites in United States, Belgium and 7 more
- Volunteers
- 64 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, HER2-positive Breast Cancer
Study of Cardiopulmonary Exercise Testing in Women Who Have HER2-Positive Breast Cancer With Mild Cardiotoxicity
The purpose of this study is to find out how much oxygen is used during a cardiopulmonary exercise test (CPET) in women who have mild cardiotoxicity after standard treatment for HER2-positive breast cancer, and to see whether the…
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, HER2-positive Metastatic Breast Cancer, Breast Cancer Stage I
- Trial name
- NCT05036252
- Testing
- Cardiopulmonary Exercise Test, Echocardiogram, Echocardiography
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer Stage IV
RWD Study in HER2+ mBC Patients in Third-Line Therapy
This retrospective observational study will collect Canadian real-world data (RWD) from HER2+ metastatic breast cancer (mBC) patients to describe treatment sequences of all therapies received in the metastatic setting, to measure…
- Trial name
- NCT04566458
- Testing
- No intervention
- Where
- 8 sites in Canada
- Volunteers
- 63 people
- Sponsor
- Exactis Innovation
HER2-positive Recurrent or Metastatic Breast Cancer
A Study of JSKN003 Versus Trastuzumab in Combination With Pertuzumab and Docetaxel as First-Line Treatment for HER2-Positive Recurrent or Metastatic Breast Cancer
This study is a randomized, controlled, open-label, multicenter, phase II superiority clinical trial. The planned study population consists of participants with HER2-positive recurrent or metastatic breast cancer who have not…
- Trial name
- NCT07545044
- Testing
- JSKN003, Trastuzumab, Pertuzumab
- Volunteers
- 60 people
- Sponsor
- Shanghai JMT-Bio Inc.
HER2-positive Recurrent/Metastatic Breast Cancer
A Study to Evaluate Inetetamab + Pyrotinib + Chemotherapy in Previously Untreated HER2-Positive Metastatic Breast Cancer
Studies H0648g and M77001 confirmed that the combination of trastuzumab with taxanes significantly improved TTP and OS, establishing the status of trastuzumab combined with taxanes as first-line standard therapy.The CLEOPATRA and…
- Trial name
- NCT05621434
- Testing
- Inetetamab, pyrotinib, chemotherapy
- Volunteers
- 63 people
- Sponsor
- Fujian Medical University
Breast Cancer
Capecitabine or Endocrinotherapy as a Maintenance Therapy Regimen at Least 2nd Line in Hormone Receptor Positive and HER2 Negative Metastatic Breast Cancer
A single-site study about the efficacy of sequential monotherapy: Capecitabine vs. endocrine therapy, in metastatic breast cancer patients with HR-positive \& HER2-negative after capecitabine-base chemotherapy.
- Trial name
- NCT03204734
- Testing
- Capecitabine, endocrine therapy
- Where
- China
- Volunteers
- 132 people
- Sponsor
- Zhejiang Cancer Hospital
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Positive Breast Carcinoma
Adding Surgery and Radiation to the Usual Treatment for HER2-Positive Breast Cancer That Had Already Spread at Diagnosis
This phase III trial evaluates the effect of adding locoregional therapy (surgery and radiation) and metastasis-directed stereotactic body radiation therapy (SBRT) to standard systemic therapy following standard HER2-targeted…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Positive Breast Carcinoma, Oligometastatic Breast Carcinoma
- Trial name
- NCT07578116
- Testing
- Biopsy Procedure, Biospecimen Collection, Breast Conservation Treatment
- Where
- 59 sites in United States
- Volunteers
- 562 people
- Sponsor
- SWOG Cancer Research Network
HER2 Positive Breast Carcinoma, Recurrent Breast Carcinoma
4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer
This trial studies the best dose and side effects of utomilumab (4-1BB agonist monoclonal antibody PF-05082566) with trastuzumab emtansine or trastuzumab in treating patients with HER2-positive breast cancer that has spread to…
- Conditions
- HER2 Positive Breast Carcinoma, Recurrent Breast Carcinoma, Stage III Breast Cancer, Stage IIIA Breast Cancer
- Trial name
- NCT03364348
- Testing
- Utomilumab, Trastuzumab, Ado-Trastuzumab Emtansine
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- George W. Sledge Jr.
Advanced Malignant Solid Neoplasm, Estrogen Receptor Positive
Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients
This phase I trial studies the side effects and best dose of everolimus and trastuzumab when given together with letrozole in treating patients with hormone receptor-positive and human epidermal growth factor (EGF) receptor 2…
- Conditions
- Advanced Malignant Solid Neoplasm, Estrogen Receptor Positive, HER2/Neu Positive, Postmenopausal
- Trial name
- NCT02152943
- Testing
- Everolimus, Laboratory Biomarker Analysis, Letrozole
- Where
- 5 sites in United States
- Volunteers
- 37 people
- Sponsor
- M.D. Anderson Cancer Center
Metastatic Breast Adenocarcinoma, Metastatic HER2-Positive Breast Carcinoma
Testing the Drug Atezolizumab or Placebo With Usual Therapy in First-Line HER2-Positive Metastatic Breast Cancer
This randomized phase III trial studies how well paclitaxel, trastuzumab, and pertuzumab with or without atezolizumab works in treating patients with breast cancer that has spread to other parts of the body (metastatic).
- Conditions
- Metastatic Breast Adenocarcinoma, Metastatic HER2-Positive Breast Carcinoma, Recurrent Breast Adenocarcinoma, Recurrent HER2-Positive Breast Carcinoma
- Trial name
- NCT03199885
- Testing
- Atezolizumab, Biopsy, Bone Scan
- Where
- 673 sites in United States, Canada
- Volunteers
- 190 people
- Sponsor
- National Cancer Institute (NCI)
Advanced Breast Cancer, Metastatic Breast Cancer
T-DXd Based Therapy Followed by Endocrine Therapy Plus Dual HER2 Blockade in First-line HER2+/ HR+ Metastatic Breast Cancer and Retreatment With T-DXd
This study will evaluate a structured sequential treatment strategy starting with T-DXd + pertuzumab upfront therapy, followed by an optimized maintenance therapy with dual HER2+blockade + CDK4/6i + ET and the opportunity to…
- Conditions
- Advanced Breast Cancer, Metastatic Breast Cancer, HER2 Positive, HR Positive
- Trial name
- DB-Guide (NCT07683754)
- Testing
- Trastuzumab deruxtecan, Trastuzumab, Pertuzumab
- Where
- 5 sites in United States
- Volunteers
- 200 people
- Sponsor
- Daiichi Sankyo
HER2-positive Breast Cancer, Metastatic Breast Cancer
Oral Metronomic Capecitabine Combined With Pyrotinib in ADC-treated HER2-positive Metastatic Breast Cancer
This is a prospective, open-label, multi-cohort, phase II study to evaluate the efficacy and safety of Oral metronomic capecitabine combined with pyrotinib in patients with HER2-positive advanced breast cancer who had received…
- Trial name
- NCT07019337
- Testing
- Pyrotinib, Capecitabine
- Volunteers
- 100 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
HER2-positive Breast Cancer
Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study
This is a phase II trial exploring the maintenance therapy with trastuzumab combined with pyrotinib or dalpiciclib and endocrine therapy in HER2-positive advanced breast cancer based on different hormone receptor (HR) statuses…
- Trial name
- NCT07179939
- Testing
- Trastuzumab rezetecan, Pyrotinib, Dalpiciclib
- Where
- China
- Volunteers
- 288 people
- Sponsor
- Fudan University
Breast Cancer Stage IV
RWS of Paclitaxel Liposome Combined With Anti-HER-2 Monoclonal Antibody
This is a retrospective, single-arm real-world study based on the National Anticancer Drug Clinical Application Monitoring Network database.The aim of this study is to evaluate the efficacy and safety of paclitaxel liposome…
- Trial name
- NCT06481553
- Testing
- first line treatment
- Where
- China
- Volunteers
- 480 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Metastatic Breast Cancer
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer
The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal…
- Trial name
- TROPiCS-02 (NCT03901339)
- Testing
- Sacituzumab Govitecan-hziy, Eribulin, Capecitabine
- Where
- 113 sites in United States, Belgium and 7 more
- Volunteers
- 543 people
- Sponsor
- Gilead Sciences
Breast Cancer Metastatic
MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer.
A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2.
- Trial name
- NCT03321981
- Testing
- Zenocutuzumab, Trastuzumab, Vinorelbine
- Where
- 25 sites in United States, Belgium and 5 more
- Volunteers
- 105 people
- Sponsor
- Merus B.V.