Clinical trials: HER-2 Positive Breast Cancer
Metastatic Breast Cancer
A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer
DESTINY-Breast07 will investigate the safety, tolerability, and anti-tumour activity of trastuzumab deruxtecan (T-DXd) in combination with other anti-cancer agents in patients with HER2-positive Metastatic Breast Cancer
- Trial name
- DB-07 (NCT04538742)
- Testing
- Trastuzumab deruxtecan, Durvalumab, Paclitaxel
- Where
- 72 sites in United States, Australia and 13 more
- Volunteers
- 245 people
- Sponsor
- AstraZeneca
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.
Metastatic Breast Cancer
Open-label Study of Safety, Tolerability and Pharmacokinetics of Multiple Doses of BI-CON-02 in Patients With HER2-positive Metastatic Breast Cancer, Previously Treated With Trastuzumab
This study will evaluate the safety and tolerability of BI-CON-02 in patients with HER2-positive metastatic breast cancer, previously treated with trastuzumab The clinical trial protocol for BI-CON-02 prescribes a start dose of…
- Trial name
- NCT03062007
- Testing
- BI-CON-02
- Where
- 6 sites in Russia
- Volunteers
- 6 people
- Sponsor
- Biointegrator LLC
ER-Positive HER2-Negative Breast Cancer
A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer
The purpose of this study is to investigate the efficacy, safety, and tolerability of camizestrant in combination with ribociclib in patients with ER+ HER2- BC who have not received any other systemic treatment for advanced…
- Trial name
- SERAFA-1 (NCT07647328)
- Testing
- Camizestrant, Ribociclib
- Where
- 89 sites in United States, France and 7 more
- Volunteers
- 150 people
- Sponsor
- AstraZeneca
Breast Cancer
Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer
The primary objective of Phase 1b will be to evaluate the safety and tolerability of TTI-101 when added to palbociclib and AI or fulvestrant administered orally to participants with hormone receptor-positive (HR+) human epidermal…
- Trial name
- NCT05384119
- Testing
- TTI-101, Palbociclib, Aromatase inhibitor (AI)
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Tvardi Therapeutics, Incorporated
HER2-Positive Primary Breast Cancer, Residual Invasive Breast Cancer
A Study of Trastuzumab Deruxtecan (T-DXd) Versus Trastuzumab Emtansine (T-DM1) in High-risk HER2-positive Participants With Residual Invasive Breast Cancer Following Neoadjuvant Therapy (DESTINY-Breast05)
Patients with HER2-positive primary breast cancer (BC) who do not achieve complete response after appropriate neoadjuvant therapy are at higher risk of disease recurrence.
- Trial name
- NCT04622319
- Testing
- DS-8201a, T-DM1
- Where
- 482 sites in United States, Argentina and 29 more
- Volunteers
- 1,600 people
- Sponsor
- Daiichi Sankyo
Breast Cancer, Hematologic Neoplasms
Phase I-II Study to Determine the Maximum Tolerated Dose (MTD) of AUY922 in Advanced Solid Malignancies, and Efficacy in HER2+ or ER+ Locally Advanced or Metastatic Breast Cancer Patients
This is a phase I/II, open-label, multicenter study of AUY922 administered intravenously in patients with advanced solid malignancies to determine the maximum tolerated dose.
- Trial name
- NCT00526045
- Testing
- AUY922 2 mg/m2
- Where
- 10 sites in United States, Netherlands and 2 more
- Volunteers
- 117 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Safety, Tolerability, and Pharmacokinetic (PK) Study of DHES0815A in Participants With Human Epidermal Growth Factor Receptor (HER)2-Positive Breast Cancer
This first-in-human, Phase 1, open-label, multicenter, dose-escalation study will evaluate the safety, tolerability, and PK of DHES0815A as a single agent in participants with advanced and/or metastatic HER2-positive breast…
- Trial name
- NCT03451162
- Testing
- DHES0815A
- Where
- 5 sites in United States, South Korea
- Volunteers
- 14 people
- Sponsor
- Genentech, Inc.
Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation
A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting
This was a prospective, multi-national, non-interventional study (NIS) collecting data from postmenopausal women, and adult men, with HR+, HER2- locally advanced or metastatic breast cancer whose tumor harbors a PIK3CA mutation…
- Trial name
- NCT04967248
- Testing
- Alpelisib, Fulvestrant
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Breast Neoplasms
Phase II Trial of BIBW 2992 in Patients With HER2-positive Metastatic Breast Cancer After Failure of Trastuzumab Therapy
The primary objective of this trial is to explore the efficacy of BIBW 2992 in HER2 positive metastatic breast cancer patients after failure of trastuzumab containing regimens.
- Trial name
- NCT00431067
- Testing
- BIBW 2992
- Where
- 12 sites in United States, United Kingdom
- Volunteers
- 41 people
- Sponsor
- Boehringer Ingelheim
HER2 + Breast Cancer
A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX87in Combination With HLX22 or Pertuzumab in the Neoadjuvant Therapy of HER2-Positive Bresat Cancer
The study is being conducted to evaluate the clinical efficacy of HLX87 in combination with HLX22 or pertuzumab vs. TCbHP in the neoadjuvant therapy of HER2-positive early or locally advanced breast cancer.
- Trial name
- NCT07294534
- Testing
- HLX87+HX22, HLX87 + Pertuzumab, TCbHP
- Volunteers
- 817 people
- Sponsor
- Shanghai Henlius Biotech
HR Negative HER2 Positive Early Breast Cancer or Locally Advanced Breast Cancer Patients
Efficacy and Safety of the Proposed Biosimilar Pertuzumab (PERT-IJS) Versus EU-Perjeta® Along With Trastuzumab and Chemotherapy (Carboplatin and Docetaxel) as Neoadjuvant Treatment in Chemotherapy naïve Patients With Early Stage or Locally Advanced HR Negative and HER2 Positive Breast Cancer
To compare the efficacy and safety of PERT-IJS (Proposed biosimilar Pertuzumab) plus trastuzumab and chemotherapy (carboplatin and docetaxel) versus EU-Perjeta plus trastuzumab and chemotherapy (carboplatin and docetaxel) in…
- Trial name
- NCT06038539
- Testing
- PERT-IJS plus trastuzumab, carboplatin and docetaxel, Perjeta plus trastuzumab, carboplatin and docetaxel
- Where
- India
- Volunteers
- 55 people
- Sponsor
- Biocon Biologics UK Ltd
Metastatic Breast Cancer
Pharmacokinetic Study of Pyrotinib and Docetaxel in Combination With Trastuzumab in Patients With HER2 Metastatic Breast Cancer
The primary objective of the study is to study the pharmacokinetics of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.
- Trial name
- NCT04367090
- Testing
- Docetaxel, trastuzumab, Pyrotinib
- Where
- China
- Volunteers
- 97 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
HER2-positive Breast Cancer
DP303c in Patients With HER2-positive Unresectable Locally Advanced, Relapsed, or Metastaticbreast Cancer
This is a study of DP303c in patients with HER2-positive advanced breast cancer.
- Trial name
- NCT05334810
- Testing
- DP303c
- Volunteers
- 191 people
- Sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Breast Cancer
Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer
This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin.
- Trial name
- NCT00093145
- Testing
- Albumin-bound paclitaxel, Carboplatin, Herceptin®
- Where
- 14 sites in United States
- Volunteers
- 32 people
- Sponsor
- Celgene
HER2-positive Breast Cancer
EUropean Real-world Experience Of Previously Treated Advanced/Metastatic HER2-positive Breast Cancer Patients Accessing Trastuzumab Deruxtecan
A named patient program (NPP) was initiated to allow patients with an unmet medical need to access trastuzumab deruxtecan (T-DXd) treatment.
- Trial name
- EUROPA T-DXd (NCT05458401)
- Testing
- Trastuzumab deruxtecan
- Where
- 21 sites in Ireland, Italy and 1 more
- Volunteers
- 256 people
- Sponsor
- Daiichi Sankyo
Breast Neoplasms
A Study of Trastuzumab Subcutaneous in Participants With Human Epidermal Growth Factor Receptor-2 (HER2) Positive Early Breast Cancer
This observational study will evaluate the efficacy, safety, tolerability and participant reported quality of life of trastuzumab (Herceptin) subcutaneous (SC) therapy in participants with HER2-positive early breast cancer in…
- Trial name
- HerSCin (NCT01959386)
- Testing
- Trastuzumab
- Where
- Germany
- Volunteers
- 1,006 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Breast Cancer
Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody for Injection
A randomized, multicenter, Phase I/IIa clinical study to evaluate the tolerability, safety, efficacy, pharmacokinetics and immunogenicity after single/multiple administration of recombinant anti-HER2 humanized monoclonal antibody…
- Trial name
- NCT04170595
- Testing
- GB221,2 mg/kg, GB221,6 mg/kg, Herceptin,6 mg/kg
- Where
- China
- Volunteers
- 132 people
- Sponsor
- Genor Biopharma Co., Ltd.
HER2-positive Breast Cancer
Clinical Study of ALT-P7 to Determine Safety, Tolerability and Pharmacokinetics in Breast Cancer Patients
This open-label study assessed the safety, tolerability and pharmacokinetics of ALT-P7(HM2-Drug Conjugate) in patients with HER2-positive metastatic breast cancer who have progressed on previous Trastuzumab-based therapy.
- Trial name
- NCT03281824
- Testing
- ALT-P7 (HM2-MMAE)
- Where
- South Korea
- Volunteers
- 27 people
- Sponsor
- Alteogen, Inc.
Early Breast Cancer
A 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 Participants With HER2-Positive Early Breast Cancer
This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC)…
- Trial name
- FeDeriCa (NCT03493854)
- Testing
- Cyclophosphamide, Doxorubicin, Docetaxel
- Where
- 107 sites in United States, Argentina and 17 more
- Volunteers
- 500 people
- Sponsor
- Hoffmann-La Roche