Clinical trials: HER2-Positive Breast Cancer
Breast Cancer
DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]
This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: cannot be removed by an operation has spread to other parts of the body
- Trial name
- NCT03523585
- Testing
- Trastuzumab deruxtecan, Capecitabine, Lapatinib
- Where
- 227 sites in United States, Australia and 13 more
- Volunteers
- 608 people
- Sponsor
- Daiichi Sankyo
Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-6452 in Adult Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Advanced/Metastatic Breast Cancer or Locally Advanced/Metastatic Solid Tumor
This is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-6452 in adult patients with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2…
- Conditions
- Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers, Metastatic (Stage IV) Breast Cancer, Ovarian Cancer
- Trial name
- NCT07612891
- Testing
- INV-6452
- Where
- China
- Volunteers
- 201 people
- Sponsor
- Shenzhen Ionova Life Sciences Co., Ltd.
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 Neoplasms
A Study of LY3484356 in Chinese Participants With Advanced Breast Cancer
This is a study of LY3484356 in Chinese participants with advanced breast cancer. Participants must have breast cancer that is estrogen receptor positive (ER+), HER2 negative (HER2-).
- Trial name
- NCT05509790
- Testing
- LY3484356
- Where
- 4 sites in China
- Volunteers
- 17 people
- Sponsor
- Eli Lilly and Company
Breast Cancer Brain Metastases
Efficacy and Safety of SPH4336 in Combination With Endocrine Therapy in Breast Cancer Patients With Brain Metastases.
This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in breast cancer Patients with brain metastases.
- Trial name
- NCT05872347
- Testing
- SPH4336 Tablets
- Where
- 25 sites in China
- Volunteers
- 52 people
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
Pre-menopausal Breast Cancer, PI3K Pathway Inhibition
A Phase Ib Dose De-escalation Study With BYL719 in Premenopausal Patients With Locally Advanced or Metastatic Breast Cancer
Based on the evidence acquired in the post-menopausal setting with everolimus and on pre-clinical evidences supporting the investigation of PI3K inhibitors, such as alpelisib and buparlisib, in combination with endocrine therapy…
- Trial name
- B-YOND (NCT02058381)
- Testing
- alpelisib (BYL719), buparlisib (BKM120)
- Where
- 15 sites in Hong Kong, South Korea and 2 more
- Volunteers
- 40 people
- Sponsor
- Novartis Pharmaceuticals
Breast Neoplasms, Breast Cancer
Trial of H3B-6545, in Women With Locally Advanced or Metastatic Estrogen Receptor-positive, HER2 Negative Breast Cancer
The primary purpose of phase 1 portion of this study is to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of H3B-6545 in women with locally advanced or metastatic estrogen receptor (ER)-positive…
- Conditions
- Breast Neoplasms, Breast Cancer, Estrogen-receptor Positive Breast Cancer, Cancer, Breast
- Trial name
- NCT03250676
- Testing
- H3B-6545
- Where
- 39 sites in United States, France and 1 more
- Volunteers
- 151 people
- Sponsor
- Eisai Inc.
Advanced Breast Cancer
A Study of SHR6390 in Combination With Letrozole or Anastrozole 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 Letrozole or Anastrozole versus placebo in combination with Letrozole or Anastrozole in Patients who have HR positive and HER2…
- Trial name
- NCT03966898
- Testing
- SHR6390 Tablets, Letrozole or Anastrozole Tablets
- Where
- China
- Volunteers
- 426 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
HER2 + Breast Cancer
A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer
The study is being conducted to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer
- Trial name
- NCT07294508
- Testing
- HLX87 + HLX22, HLX87 + Pertuzumab, T-Dxd + Pertuzumab
- Where
- China
- Volunteers
- 706 people
- Sponsor
- Shanghai Henlius Biotech
Metastatic Breast Cancer
Expanded Access Program to Provide Abemaciclib (LY2835219) for the Treatment of Metastatic Breast Cancer
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.
- Trial name
- NCT02792725
- Testing
- Abemaciclib
- Where
- 10 sites in United States
- Sponsor
- Eli Lilly and Company
Locally Advanced or Metastatic Breast Cancer
Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer
This study is designed to evaluate the safety and efficacy of SPH4336 combined with letrozole in first-line treatment of locally advanced or metastatic breast cancer
- Trial name
- NCT05744687
- Testing
- SPH4336 Tablets 400mg
- Where
- 9 sites in China
- Volunteers
- 374 people
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
HER2-positive Breast Cancer, Metastatic Breast Cancer
SMP-656 for HER2-Positive Advanced Breast Cancer
The goal of this clinical trial is to learn if single-agent SMP-656 works to treat patients with HER2-positive locally advanced or metastatic breast cancer who have progressed after prior HER2-targeted topoisomerase inhibitor…
- Conditions
- HER2-positive Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer (LABC)
- Trial name
- NCT07726342
- Testing
- SMP-656 Injection
- Where
- 15 sites in China
- Volunteers
- 60 people
- Sponsor
- Chengdu SciMount Pharmatech Co., Ltd.
Breast Cancer
Safety and Efficacy of Trastuzumab as Part of Breast Cancer Treatment Regimen
This is a prospective, Phase IV, multi-center, single arm, open-label, interventional study to evaluate the safety of trastuzumab for the treatment of human epidermal growth factor receptor 2 protein (HER2)-positive node positive…
- Trial name
- NCT02419742
- Testing
- Carboplatin, Cyclophosphamide, Docetaxel
- Where
- 6 sites in India
- Volunteers
- 110 people
- Sponsor
- Hoffmann-La Roche
Metastatic HER2-positive Breast Cancer
A Study Comparing the Efficacy and Safety of Zanidatamab to Trastuzumab, Each in Combination With Physician's Choice Chemotherapy, for the Treatment of Participants With Metastatic HER2-positive Breast Cancer
The efficacy and safety of zanidatamab in combination with physician's choice of chemotherapy compared with trastuzumab in combination with physician's choice of chemotherapy will be evaluated for the treatment of participants…
- Trial name
- NCT06435429
- Testing
- Zanidatamab, Trastuzumab, Eribulin
- Where
- 166 sites in United States, Australia and 13 more
- Volunteers
- 550 people
- Sponsor
- Jazz Pharmaceuticals
Breast Cancer
A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)
The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine…
- Trial name
- NCT05104866
- Testing
- Dato-DXd, Capecitabine, Gemcitabine
- Where
- 167 sites in United States, Argentina and 18 more
- Volunteers
- 732 people
- Sponsor
- AstraZeneca
Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer
ONO-4578-06:Phase I Study of ONO-4578 and Letrozole Plus CDK4 /6 Inhibitors in Breast Cancer
This is a multicenter, open-label, non-controlled, phase I study to investigate the tolerability and safety of ONO-4578 used in combination with standard-of-care letrozole and a CDK4/6 inhibitor (palbociclib or Abemaciclib) as…
- Conditions
- Hormone Receptor-positive Breast Cancer, HER2-negative Breast Cancer, Metastatic Breast Cancer, Recurrent Breast Cancer
- Trial name
- NCT06570031
- Testing
- ONO-4578, letrozole, Palbociclib
- Where
- 13 sites in Japan
- Volunteers
- 46 people
- Sponsor
- Ono Pharmaceutical Co., Ltd.
Breast Cancer
Study of Amcenestrant (SAR439859) Versus Tamoxifen for Patients With Hormone Receptor-positive (HR+) Early Breast Cancer, Who Have Discontinued Adjuvant Aromatase Inhibitor Therapy Due to Treatment-related Toxicity
This was a phase III, randomized, double blind, multicenter, 2-arm study evaluating the efficacy and safety of amcenestrant compared with tamoxifen in participants with hormone receptor-positive early breast cancer who…
- Trial name
- AMEERA-6 (NCT05128773)
- Testing
- Amcenestrant, Tamoxifen
- Where
- 2 sites in Chile, China
- Volunteers
- 3 people
- Sponsor
- Sanofi
HER2-positive Breast Cancer
A Study of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer
This study is a phase II clinical trial to evaluate the safety and efficacy of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel as first-line treatment in patients with unresectable locally advanced or metastatic…
- Trial name
- NCT06445400
- Testing
- BL-M07D1, Pertuzumab, Docetaxel
- Where
- China
- Volunteers
- 83 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Metastatic Breast Cancer
Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or Metastatic
The purpose of this study is to find out what effect the combination of letrozole (brand name: Femara) and dasatinib (brand name: Sprycel) has on metastatic breast cancer compared to letrozole alone
- Trial name
- NCT00696072
- Testing
- Dasatinib, Letrozole
- Where
- 27 sites in United States
- Volunteers
- 120 people
- Sponsor
- Bristol-Myers Squibb
HER2-positive Early Breast Cancer
A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer
The study will compare PK, efficacy, safety, and immunogenicity of SIBP-01 (Trastuzumab Biosimilar) in combination with Docetaxel and Carboplatin versus Herceptin® (CN-Trastuzumab) approved in the CN in combination with Docetaxel…
- Trial name
- NCT03989037
- Testing
- SIBP-01, Herceptin, Docetaxel
- Where
- China
- Volunteers
- 580 people
- Sponsor
- Shanghai Institute Of Biological Products