Clinical trials: Her2 Positive Metastatic Breast Cancer
HER2 + Breast Cancer
A Phase II Study of HLX22 in Combination With Trastuzumab and Chemotherapy in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients
This is a phase II study of HLX22 in combination with trastuzumab and chemotherapy versus placebo in combination with trastuzumab and chemotherapy in locally advanced and/or metastatic HER2-Positive breast cancer previously…
- Trial name
- NCT07824869
- Testing
- HLX22, Trastuzumab, Capecitabine
- Volunteers
- 90 people
- Sponsor
- Shanghai Henlius Biotech
Metastatic Breast Cancer, Breast Cancer
Fulvestrant and EVerolimus Plus EXemestane in Metastatic Breast Cancer
This is a multi-center, randomized, open-label, parallel group study designed to evaluate efficacy and safety of fulvestrant followed, at progression, by examestane and everolimus versus examestane and everolimus followed, at…
- Conditions
- Metastatic Breast Cancer, Breast Cancer, Hormone Receptor Positive Tumor, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
- Trial name
- FEVEX (NCT02404051)
- Testing
- Everolimus, Exemestane, Fulvestrant
- Where
- 41 sites in Italy
- Volunteers
- 745 people
- Sponsor
- Consorzio Oncotech
HER2 Positive Breast Carcinoma, Recurrent Breast Carcinoma
Capecitabine and Lapatinib Ditosylate With or Without Cixutumumab in Treating Patients With Previously Treated HER2-Positive Stage IIIB-IV Breast Cancer
This phase II trial studies capecitabine and lapatinib ditosylate to see how well they work compared with capecitabine, lapatinib ditosylate, and cixutumumab in treating patients with previously treated HER2-positive stage…
- Conditions
- HER2 Positive Breast Carcinoma, Recurrent Breast Carcinoma, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7
- Trial name
- NCT00684983
- Testing
- Capecitabine, Cixutumumab, Lapatinib Ditosylate
- Where
- 390 sites in United States
- Volunteers
- 64 people
- Sponsor
- National Cancer Institute (NCI)
Unresectable or Metastatic Breast Cancer
Clinical Study of HRS-8080 in Combination With Dalpiciclib Isethionate Tablets in Patients With Unresectable or Metastatic Breast Cancer
This is a multicenter, open phase Ib/II clinical study, which is divided into two phases: dose exploration and efficacy expansion.
- Trial name
- NCT06167694
- Testing
- HRS-8080; Dalpiciclib Isethionate Tablets
- Where
- 2 sites in China
- Volunteers
- 146 people
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Breast Cancer
Dose Escalation Followed by Study of RAD001 in Combination With Trastuzumab in HER2-Positive Metastatic Breast Cancer
The purpose of this research study is to determine the safety of RAD001 and the highest dose of this drug that can be given to people with HER2-positive metastatic breast cancer safely in combination with trastuzumab.
- Trial name
- NCT00458237
- Testing
- Everolimus, Trastuzumab
- Where
- 2 sites in United States
- Volunteers
- 11 people
- Sponsor
- Beth Israel Deaconess Medical Center
Unrespectable Locally Advanced and or Metastatic HER2 Positive Breast Cancer Participants
JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer
This study is designed to compare the safety and efficacy of JSKN003 versus T-DM1 in unrespectable locally advanced and/or metastatic HER2-positive breast cancer participants previously treated with trastuzumab and taxane.
- Trial name
- NCT06846437
- Testing
- JSKN003, Trastuzumab emtansine (T-DM1)
- Where
- China
- Volunteers
- 228 people
- Sponsor
- Shanghai JMT-Bio Inc.
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
Metastatic Breast Cancer
Lapatinib+Vinorelbine vs Vinorelbine HER2 Positive Metastatic Breast Cancer Progressed After Lapatinib/Trastuzumab
The investigators address the clinical efficacy of continuing lapatinib treatment combined with vinorelbine after the progression of both trastuzumab and lapatinib treatment compared with vinorelbine alone in HER2 positive…
- Trial name
- LV (NCT01730677)
- Testing
- Lapatinib, Vinorelbine
- Where
- South Korea
- Volunteers
- 150 people
- Sponsor
- National Cancer Center, Korea
HER2-positive Breast Cancer
HB1801 Combined Treatment of HER2-positive Breast Cancer
This study is designed to evaluate the safety and efficacy of HB1801 combination therapy as first-line treatment in HER2-positive unresectable locally advanced or metastatic breast cancer.
- Trial name
- NCT07116824
- Testing
- HB1801, Trastuzumab, Pertuzumab
- Volunteers
- 80 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Breast Cancer
Monalizumab and Trastuzumab In Metastatic HER2-pOSitive breAst Cancer: MIMOSA-trial
In this phase II clinical trial the efficacy of the combination of monalizumab and trastuzumab is assessed in patients with metastatic or locally incurable HER2-positive breast cancer
- Trial name
- MIMOSA (NCT04307329)
- Testing
- Monalizumab, Trastuzumab
- Where
- Netherlands
- Volunteers
- 12 people
- Sponsor
- The Netherlands Cancer Institute
Anatomic Stage IV Breast Cancer AJCC v8, Estrogen-receptor-positive Breast Cancer
Adaptive Therapy With Capecitabine for Treatment of Metastatic ER Positive, HER2 Negative Breast Cancer
This phase II trial evaluates the effect of capecitabine on tumor response using imaging and tumor markers to adjust dose (adaptive therapy) in patients with estrogen receptor (ER) positive, HER2 negative breast cancer that has…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Estrogen-receptor-positive Breast Cancer, Metastatic HER2-Negative Breast Carcinoma, Metastatic Breast Cancer
- Trial name
- NCT06525766
- Testing
- Biospecimen Collection, Bone Scan, Capecitabine
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Mayo Clinic
Metastatic Breast Cancer
A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi
This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs.
- Trial name
- BELLE-3 (NCT01633060)
- Testing
- Fulvestrant, BKM120
- Where
- 197 sites in United States, Argentina and 20 more
- Volunteers
- 432 people
- Sponsor
- Novartis Pharmaceuticals
Tubular Breast Cancer Stage II, Mucinous Breast Cancer Stage II
Addition of Carboplatin to Neoadjuvant Therapy for Triple-negative and HER2-positive Early Breast Cancer
Study participants with primary breast cancer will receive a standard chemotherapy with an anthracycline and a taxane as well as trastuzumab in case of HER2-positive tumors at doses and duration in concordance to current…
- Conditions
- Tubular Breast Cancer Stage II, Mucinous Breast Cancer Stage II, Breast Cancer Female NOS, Invasive Ductal Breast Cancer
- Trial name
- GeparSixto (NCT01426880)
- Testing
- Carboplatin, background treatment
- Where
- 3 sites in Germany
- Volunteers
- 595 people
- Sponsor
- GBG Forschungs GmbH
Metastatic Breast Cancer
A Study of Trastuzumab Emtansine in Combination With Atezolizumab or Placebo as a Treatment for Participants With Human Epidermal Growth Factor 2 (HER2)-Positive and Programmed Death-ligand 1 (PD-L1)-Positive Locally Advanced (LABC) or Metastatic Breast Cancer (MBC)
This study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with HER2-positive and PD-L1-positive LABC or…
- Trial name
- KATE3 (NCT04740918)
- Testing
- Trastuzumab Emtansine, Atezolizumab
- Where
- 51 sites in United States, Australia and 17 more
- Volunteers
- 96 people
- Sponsor
- Hoffmann-La Roche
Locally Advanced (Inoperable) or Metastatic Breast Cancer
Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer
Phase III, double-blind, randomised study assessing the efficacy of capivasertib + fulvestrant vs placebo + fulvestrant for the treatment of patients with locally advanced (inoperable) or metastatic HR+/HER2- breast cancer…
- Trial name
- CAPItello-291 (NCT04305496)
- Testing
- Fulvestrant, Capivasertib
- Where
- 215 sites in United States, Argentina and 17 more
- Volunteers
- 818 people
- Sponsor
- AstraZeneca
Breast Cancer
Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer
Evaluation of the Efficacy and Safety of TQB3616 Capsules Combined with Hormonal Therapy in a Phase II Clinical Trial for Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor-Resistant, HR-Positive, HER2-Negative…
- Trial name
- NCT06702618
- Testing
- TQB3616 capsule+Fulvestrant Injection
- Where
- 13 sites in China
- Volunteers
- 33 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Breast Cancer
A Study to Evaluate the Antitumor Activity and Safety of IPI-504 in Patients With Advanced Breast Cancer
To evaluate the antitumor activity following treatment with IPI-504 in patients with breast cancer.
- Trial name
- NCT00627627
- Testing
- IPI-504
- Where
- 7 sites in United States
- Volunteers
- 56 people
- Sponsor
- MedImmune LLC
Metastatic Breast Cancer
A Study of Trastuzumab Emtansine (Trastuzumab-MCC-DM1, T-DM1) in Combination With Pertuzumab Administered to Patients With Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab
This was a multi-institutional, multinational, open-label, single-arm Phase Ib/II study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of trastuzumab emtansine (trastuzumab-MCC-DM1) administered by…
- Trial name
- NCT00875979
- Testing
- Trastuzumab emtansine [Kadcyla] 3.0 mg/kg, Trastuzumab emtansine [Kadcyla] 3.6 mg/kg, Pertuzumab 420 mg
- Where
- 20 sites in United States, Belgium and 5 more
- Volunteers
- 67 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Eribulin With Trastuzumab as First-line Therapy for Locally Recurrent or Metastatic HER2 Positive Breast Cancer
This is a multicenter phase 2 study designed to evaluate the safety and efficacy of eribulin mesylate in combination with trastuzumab as first line treatment in female subjects with locally recurrent or metastatic human epidermal…
- Trial name
- NCT01269346
- Testing
- Eribulin Mesylate
- Where
- 26 sites in United States
- Volunteers
- 52 people
- Sponsor
- Eisai Inc.
Bone Metastases, HER2-positive Breast Cancer
Copper Cu 64-DOTA-Trastuzumab PET in Predicting Response to Treatment With Ado-Trastuzumab Emtansine in Patients With Metastatic HER2 Positive Breast Cancer
This pilot clinical trial studies how well copper Cu 64-tetra-azacyclododecanetetra-acetic acid (DOTA)-trastuzumab positron emission tomography (PET) works in predicting response to treatment with ado-trastuzumab emtansine in…
- Conditions
- Bone Metastases, HER2-positive Breast Cancer, Liver Metastases, Lung Metastases
- Trial name
- NCT02226276
- Testing
- fludeoxyglucose F 18, positron emission tomography, computed tomography
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- City of Hope Medical Center