Clinical trials: HER2 Positive Breast Cancer
Breast Cancer
A Study of Subcutaneous At Home Administration of Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2-positive (HER2+) Early Breast Cancer (eBC)
This single arm, multicenter study will evaluate the safety of assisted subcutaneous administration of trastuzumab in participants with HER2+ eBC.
- Trial name
- NCT01926886
- Testing
- Trastuzumab
- Where
- 23 sites in Belgium, Israel
- Volunteers
- 102 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Breast Cancer
Treatment Protocol of Tucatinib With Capecitabine and Trastuzumab in Patients With Unresectable Previously Treated HER2+ Breast Cancer
The purpose of this program is to provide access to tucatinib in the United States before FDA approval. Participants will receive a combination treatment of capecitabine, trastuzumab, and tucatinib.
- Trial name
- NCT04220203
- Testing
- Tucatinib, Capecitabine, Trastuzumab
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Advanced Breast Cancer
A Study of SHR6390 in Combination With Fulvestrant in Patients With HR Positive and HER2 Negative Advanced Breast Cancer
This is a phase III clinical trial to evaluate the efficacy and safety of SHR6390 in combination with Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 negative recurrent/metastatic…
- Trial name
- NCT03927456
- Testing
- SHR6390, Fulvestrant
- Where
- China
- Volunteers
- 357 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer
Study of PIK3CA Mutations and Effectiveness and Tolerability Outcomes of Alpelisib in Real-world
SPEAR is a non-interventional / observational, prospective, multicenter study planned to be conducted across ~ 30 sites in India, among HR-positive and HER2-negative ABC/MBC patients.
- Trial name
- SPEAR (NCT05022342)
- Testing
- alpelisib plus fulvestrant
- Where
- 28 sites in India
- Volunteers
- 595 people
- Sponsor
- Novartis Pharmaceuticals
Locally Advanced or Metastatic Breast Cancer
A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC
This study is a multicenter, open-label, phase 2 clinical study to evaluate the efficacy, safety and pharmacokinetics of YL202 in patients with locally advanced or metastatic breast cancer with TNBC, HR-positive…
- Trial name
- NCT06439771
- Testing
- YL202 should be intravenously infused
- Where
- China
- Volunteers
- 180 people
- Sponsor
- MediLink Therapeutics (Suzhou) Co., Ltd.
Breast Cancer
A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment
This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC)…
- Trial name
- NCT01702571
- Testing
- Trastuzumab Emtansine
- Where
- 300 sites in Argentina, Australia and 41 more
- Volunteers
- 2,185 people
- Sponsor
- Hoffmann-La Roche
Breast Neoplasms
A Study of Multiple Immunotherapy-Based Treatment Combinations in Hormone Receptor (HR)-Positive Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
This study is designed to evaluate the efficacy, safety, and pharmacokinetics of several immunotherapy-based combination treatments in participants with inoperable locally advanced or metastatic HR-positive, HER2-negative breast…
- Trial name
- MORPHEUS HR+BC (NCT03280563)
- Testing
- Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody, Bevacizumab, Entinostat
- Where
- 22 sites in United States, Israel and 1 more
- Volunteers
- 144 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced or Metastatic Hormone Receptor(HR)-Positive and Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer
This trial was designed to evaluate the maximum tolerated dose (MTD) and phase II recommended dose (RP2D) in subjects with TQB3912 tablets combined with fulvestrant injection and TQB3616 capsules for locally advanced or…
- Trial name
- NCT06851442
- Testing
- TQB3912 tablets in combination with fulvestrant injection± TQB3616 capsules
- Where
- 17 sites in China
- Volunteers
- 8 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Metastatic Breast Cancer
SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer
The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is superior to physician's choice in prolonging progression free survival.
- Trial name
- TULIP (NCT03262935)
- Testing
- (vic-)trastuzumab duocarmazine, Physician's choice
- Where
- 90 sites in United States, Belgium and 9 more
- Volunteers
- 437 people
- Sponsor
- Byondis B.V.
Breast Cancer
A Clinical Study of TQB2102 Versus Docetaxel Plus Trastuzumab and Pertuzumab in the Treatment of HER2 Positive Recurrent or Metastatic Breast Cancer
This Phase III trial adopts a randomized, open label, positive drug control, and multicenter trial design. Subjects who meet the criteria are randomly divided into 1:1 groups and receive treatment with TQB2102 injection or…
- Trial name
- NCT07003074
- Testing
- TQB2102 for Injection, Docetaxel combined + Trastuzumab +Pertuzumab
- Where
- 25 sites in China
- Volunteers
- 642 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
HER2-positive Breast Cancer, HER2 Gene Mutation
Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene
Open-label, Phase I-II, first-in-human (FIH) study for A166 monotherapy in HER2-expressing or amplified patients who progressed on or did not respond to available standard therapies.
- Conditions
- HER2-positive Breast Cancer, HER2 Gene Mutation, HER-2 Gene Amplification, HER2 Positive Gastric Cancer
- Trial name
- NCT03602079
- Testing
- A166
- Where
- 10 sites in United States
- Volunteers
- 49 people
- Sponsor
- Klus Pharma Inc.
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 Study of Herceptin (Trastuzumab) in Women With Metastatic Breast Cancer
This 2 arm study will assess the efficacy and safety of intravenous Herceptin with or without a taxane for the first line treatment of metastatic breast cancer in women who have relapsed at least 12 months after a minimum of 10…
- Trial name
- NCT00475670
- Testing
- Trastuzumab, Taxane (docetaxel or paclitaxel)
- Where
- 57 sites in Australia, Austria and 13 more
- Volunteers
- 44 people
- Sponsor
- Hoffmann-La Roche
Breast Neoplasms, Breast Diseases
A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases
This is a randomized, open, parallel-controlled, multicenter, phase II/III, seamless design clinical trial to compare the efficacy and safety of RC48-ADC with capecitabine + lapatinib in locally advanced or metastatic human…
- Conditions
- Breast Neoplasms, Breast Diseases, Capecitabine, HER2-positive Breast Cancer
- Trial name
- NCT03500380
- Testing
- RC48-ADC, Lapatinib, Capecitabine
- Where
- 67 sites in China
- Volunteers
- 301 people
- Sponsor
- RemeGen Co., Ltd.
Breast Neoplasms
Study of the Pharmacokinetics and Safety of Trastuzumab Emtansine in Chinese Participants With Locally Advanced Inoperable or Metastatic HER2+ Breast Cancer
This is an open-label Phase I study of single-agent trastuzumab emtansine administered by intravenous (IV) infusion. The study will characterize the pharmacokinetics of trastuzumab emtansine and its relevant analytes and the…
- Trial name
- NCT03153163
- Testing
- Trastuzumab Emtansine
- Where
- China
- Volunteers
- 11 people
- Sponsor
- Hoffmann-La Roche
Non-Small Cell Lung Cancer, Breast Cancer
A Multi-Center Study of Ibrutinib in Combination With MEDI4736 in Subjects With Relapsed or Refractory Solid Tumors
This is a Phase 1b/2, multi-center study to assess the safety and efficacy of ibrutinib in combination with durvalumab (MEDI4736) in participants with relapsed or refractory solid tumors.
- Conditions
- Non-Small Cell Lung Cancer, Breast Cancer, Pancreatic Cancer
- Trial name
- NCT02403271
- Testing
- Ibrutinib, Durvalumab
- Where
- 17 sites in United States
- Volunteers
- 124 people
- Sponsor
- Pharmacyclics LLC.
Advanced Breast Cancer
Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer
The purpose of this study is to assess the safety and efficacy of alpelisib plus fulvestrant in men and postmenopausal women with hormone receptor (HR) positive, human epidermal growth factor 2 (HER2)-negative, advanced breast…
- Trial name
- NCT04524000
- Testing
- Alpelisib, Fulvestrant
- Where
- 15 sites in Japan
- Volunteers
- 24 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Herceptin (Trastuzumab) in Treating Women With Human Epidermal Growth Factor Receptor (HER) 2-Positive Primary Breast Cancer
The purpose of this trial is to evaluate Herceptin treatment for 1 year and 2 years (versus observation/no Herceptin) in women with HER2-overexpressing primary breast cancer who have completed (neo-)adjuvant systemic…
- Trial name
- HERA (NCT00045032)
- Testing
- Herceptin
- Where
- 203 sites in Argentina, Australia and 31 more
- Volunteers
- 5,099 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of inavolisib in combination with fulvestrant compared with inavolisib in combination with fulvestrant in participants with PIK3CA-mutated, HR-positive…
- Trial name
- optINAVO (NCT07368998)
- Testing
- Inavolisib, Fulvestrant
- Where
- 34 sites in United States, Argentina and 6 more
- Volunteers
- 80 people
- Sponsor
- Hoffmann-La Roche
Ovarian Neoplasms, Peritoneal Neoplasms
A Study of Felmetatug Vedotin/SGN-B7H4V in Advanced Solid Tumors
The purpose of the study is to test the safety of the medicine called Felmetatug Vedotin alone and with pembrolizumab in participants with solid tumors. It will also look at the side effects of this medicine.
- Conditions
- Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms, Triple Negative Breast Neoplasms
- Trial name
- NCT05194072
- Testing
- Felmetatug Vedotin, Pembrolizumab
- Where
- 27 sites in United States, Canada and 3 more
- Volunteers
- 250 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer