Clinical trials: HER2-positive
Breast Cancer
HER2(Human Epidermal Growth Factor Receptor 2) -Positive Metastatic Breast Cancer in Russia
Planned study population consists of approximately 1,000 adult patients with HER2-positive mBC receiving anti-HER2 therapy in about 50 oncological centers (in each center it is expected to recruit about 20 patients) in different…
- Trial name
- NCT05905939
- Where
- 29 sites in Russia
- Volunteers
- 774 people
- Sponsor
- AstraZeneca
Early Breast Cancer
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free…
- Trial name
- Adjuvant WIDER (NCT05827081)
- Testing
- Ribociclib, Letrozole, Ansastrozole
- Where
- 214 sites in United States, Argentina and 14 more
- Volunteers
- 1,466 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Study of Tucatinib and Doxil in Participants With Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Metastatic Breast Cancer
This clinical trial is evaluating tucatinib in combination with Doxil in participants with human epidermal growth factor 2 positive (HER2+) locally advanced or metastatic breast cancer.
- Trial name
- NCT05748834
- Testing
- Tucatinib, Doxil
- Where
- 8 sites in United States
- Volunteers
- 36 people
- Sponsor
- SCRI Development Innovations, LLC
Breast Cancer
Docetaxel and Cyclophosphamide Compared to Anthracycline-Based Chemotherapy in Treating Women With HER2-Negative Breast Cancer
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of breast cancer cells, either by killing the cells or by stopping them from dividing.
- Trial name
- NCT01547741
- Testing
- Doxorubicin, Cyclophosphamide, Docetaxel
- Where
- 915 sites in United States, Puerto Rico
- Volunteers
- 4,242 people
- Sponsor
- NSABP Foundation Inc
Gastric Cancer
A Study of Trastuzumab in Combination With TS-ONE & Cisplatin in First-line Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced Gastric Cancer
The investigators hypothesis is that the combination of TS-ONE with cisplatin and trastuzumab is safe and as effective as combination treatment for HER2 positive gastric cancer.
- Trial name
- NCT01228045
- Testing
- Trastuzumab in Combination with TS-ONE and cisplatin
- Where
- Singapore
- Volunteers
- 30 people
- Sponsor
- National University Hospital, Singapore
Breast Cancer With Brain Metastasis
HER2-positive Breast Cancer With Brain Metastasis (GCC 1345)
Primary Objective: To determine if treatment with SRS followed by a HER-2 directed therapy regimen results in a 6-month distant brain relapse rate of less than 30%. Secondary Objectives: 1.
- Trial name
- NCT01924351
- Testing
- Stereotactic Radiosurgery plus HER-2 directed therapy in HER2-positive Breast Cancer with Brain Metastasis
- Where
- United States
- Sponsor
- University of Maryland, Baltimore
Breast Cancer
The Efficacy and Safety of Neoadjuvant Trastuzumab Plus Taxane With and Without Pertuzumab Therapy
This study is a Non-Interventional Study (NIS) with secondary data usage. It is designed as a multi-center retrospective cohort study in which the data of adult locally advanced HER2-positive breast cancer patients, who are…
- Trial name
- HER2PATH (NCT04765124)
- Where
- Turkey (Türkiye)
- Volunteers
- 1,500 people
- Sponsor
- Ahmet Bilici
Breast Cancer
A Study of AC682 for the Treatment of Locally Advanced or Metastatic ER+ Breast Cancer
This clinical trial is evaluating a drug called AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer.
- Trial name
- NCT05080842
- Testing
- AC682
- Where
- 5 sites in United States
- Volunteers
- 21 people
- Sponsor
- Accutar Biotechnology Inc
Breast Cancer
Chemotherapy-free Trastuzumab and Pertuzumab in HER2-positive Breast Cancer: FDG-PET Response-adapted Strategy.
The study assess the early metabolic effects of neoadjuvant treatment with trastuzumab and pertuzumab (± endocrine therapy) on the primary tumor and axillary lymph nodes and their predictive value for pathologic complete response…
- Trial name
- PHERGain (NCT03161353)
- Testing
- Perjeta, Herceptin, Docetaxel
- Where
- 56 sites in Belgium, France and 5 more
- Volunteers
- 377 people
- Sponsor
- MedSIR
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma
Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer
This phase I trial studies the effects (good and bad) of adding copanlisib to the usual therapy of fulvestrant and abemaciclib in treating patients with hormone receptor positive and HER2 negative breast cancer that has spread…
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Breast Carcinoma, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma
- Trial name
- NCT03939897
- Testing
- Abemaciclib, Biopsy Procedure, Biospecimen Collection
- Where
- 14 sites in United States
- Volunteers
- 24 people
- Sponsor
- National Cancer Institute (NCI)
Breast Cancer
Phase I Study of the Combination of MLN9708 and Fulvestrant
Participants in this study will have been diagnosed with advanced breast cancer that has become worse while being treated with fulvestrant. Participants will have estrogen-receptor positive disease, and have completed menopause.
- Trial name
- Millennium (NCT02384746)
- Testing
- Fulvestrant, MLN9708
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Dartmouth-Hitchcock Medical Center
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
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
HR+/HER2+ Early Breast Cancer
Fovinaciclib Plus Aromatase Inhibitors and Dual HER2 Blockade in a Response-Adapted Neoadjuvant Strategy for HR-Positive/HER2-Positive Early Breast Cancer
This prospective, response-adapted phase II study evaluates the efficacy and safety of neoadjuvant fovinaciclib in combination with aromatase inhibitors and dual HER2 blockade in patients with HR-positive/HER2-positive early…
- Trial name
- TAYLOR-003 (NCT07616427)
- Testing
- Fovinaciclib, Aromatase Inhibitors, Trastuzumab + Pertuzumab
- Where
- 3 sites in China
- Volunteers
- 100 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Early-Stage Breast Carcinoma, HER-2 Positive Breast Cancer
Neoadjuvant Response-guided Treatment of HER2 Positive Breast Cancer
The purpose of this trial is to evaluate efficacy and toxicity of either the combination of docetaxel, trastuzumab sc and pertuzumab (arm A) or trastuzumab emtansin (arm B).
- Trial name
- PREDIX HER2 (NCT02568839)
- Testing
- docetaxel + trastuzumab sc + pertuzumab, trastuzumab emtansin
- Where
- 7 sites in Sweden
- Volunteers
- 202 people
- Sponsor
- Thomas Hatschek
Breast Cancer
A Non-interventional Study for Women With HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer to Evaluate the Real-world Effectiveness of Treatment Algorithms Beginning With Ribociclib + AI/FUL, or With Endocrine Therapy or Chemotherapy as First Line Treatment
This is a non-interventional observational study conducted in Germany to evaluate the real-world effectiveness, tolerability, safety, and quality of life in patients with locally advanced/metastatic HR+/HER2- breast cancer…
- Trial name
- RIBANNA (NCT06311383)
- Testing
- First-line Ribociclib + endocrine therapy, First-line endocrine therapy, First-line chemtherapy
- Where
- 265 sites in Germany
- Volunteers
- 2,610 people
- Sponsor
- Novartis Pharmaceuticals
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Rifaximin for the Treatment of Gastrointestinal Toxicities Related to Pertuzumab-Based Therapy in Patients With Stage I-III HER2 Positive Breast Cancer
This phase II trial studies how well rifaximin works for the treatment of gastrointestinal toxicities related to pertuzumab-based therapy in patients with stage I-III HER2 positive breast cancer.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
- Trial name
- NCT04249622
- Testing
- Best Practice, Questionnaire Administration, Rifaximin
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Mayo Clinic
Breast Cancer
A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.
In the phase I part, to determine the recommended doses (RD) and dosing regimens of [177Lu]Lu-NeoB in combination with capecitabine in adult patients with gastrin releasing peptide receptor positive, estrogen receptor-positive…
- Trial name
- NeoB-Cap1 (NCT06247995)
- Testing
- [68Ga]Ga-NeoB, [177Lu]Lu-NeoB, Capecitabine
- Where
- 28 sites in United States, Australia and 11 more
- Volunteers
- 20 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer, Breast Cancer - Female
TEEL Study- Phase 1 Tamoxifen and Ribociclib (LEE011) in Advanced ER+ (HER2 Negative) Breast Cancer
The purpose of this study is to find out if the investigational drug Ribociclib (LEE011), when taken with standard treatment (Tamoxifen +/- Goserelin) is safe and has beneficial effects in pre-menopausal and post-menopausal women…
- Conditions
- Breast Cancer, Breast Cancer - Female, Breast Cancer - Male
- Trial name
- NCT02586675
- Testing
- Tamoxifen, Ribociclib, Goserelin
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Breast Cancer
A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer
This trial is a randomized, open-label, multicenter Phase II study designed to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally recurrent or metastatic HR-positive, HER2-low expressing breast…
- Trial name
- NCT07678957
- Testing
- BL-M07D1, DS-8201
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
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