Clinical trials: HER2-low Breast Cancer
Breast Cancer Metastatic
MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer.
A Phase 2, open-label, multicenter international study will be performed to evaluate the efficacy of MCLA-128-based combinations. Three combination treatments will be evaluated, two in Cohort 1 and one in Cohort 2.
- Trial name
- NCT03321981
- Testing
- Zenocutuzumab, Trastuzumab, Vinorelbine
- Where
- 25 sites in United States, Belgium and 5 more
- Volunteers
- 105 people
- Sponsor
- Merus B.V.
Breast Cancer
Estimation of the Prevalence of HER2 Low and Describe the SoC, Treatment Patterns, and Outcome in Real-world Practice Among Unresectable and/or Metastatic Breast Cancer Patients With HER2 Low Status
This is a worldwide, multicenter, non-interventional, retrospective study of patient medical records from metastatic breast cancer (mBC) patients previously identified as human epidermal growth factor receptor 2 negative…
- Trial name
- NCT04807595
- Testing
- None (Observational study)
- Where
- 13 sites in United States, Australia and 8 more
- Volunteers
- 798 people
- Sponsor
- AstraZeneca
Neoplasms, Breast Neoplasms
Phase I/II AZD8931/Paclitaxel in Treatment of Advanced Solid Tumours (Phase I) and Advanced Breast Cancer (Phase II)
The main purpose of this study is to determine if AZD8931 can improve the efficacy of standard chemotherapy for the treatment of advanced breast cancer.
- Conditions
- Neoplasms, Breast Neoplasms, Breast Cancer
- Trial name
- THYME (NCT00900627)
- Testing
- AZD8931, Paclitaxel
- Where
- 38 sites in Belgium, Brazil and 12 more
- Volunteers
- 330 people
- Sponsor
- AstraZeneca
Neoplasms, Breast
A Study to Examine the Effects of Low and High-fat Meals on Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients
This study will be a randomized 3-treatment, cross-over study to evaluate the bioavailability of lapatinib administered after a high or low-fat meal.
- Trial name
- NCT00821054
- Testing
- Lapatinib
- Where
- 5 sites in United States, Canada and 1 more
- Volunteers
- 24 people
- Sponsor
- GlaxoSmithKline
Cancers With HER2 Expression
A First in Human Study of BAY2701439 to Look at Safety, How the Body Absorbs, Distributes and Excretes the Drug, and How Well the Drug Works in Participants With Advanced Cancer Expressing the HER2 Protein
In this study, researchers want to learn about the safety of drug BAY2701439 and how well the drug works in patients with advanced cancer that has the protein HER2 (Human Epidermal growth factor Receptor 2) and cannot be cured by…
- Trial name
- NCT04147819
- Testing
- BAY2701439
- Where
- 6 sites in United States, United Kingdom
- Volunteers
- 14 people
- Sponsor
- Bayer
Breast Neoplasms, Breast Cancer
HER2 TREAT Study: Retrospective Study to Estimate the Prevalence of HER2-low in Unresectable and/or Metastatic Breast Cancer Patients Who Progress on Anti-Cancer Therapy Identified as HER2-Negative From Patient Medical Records in The Gulf Cooperation Council
HER2-low Breast cancer (BC) has emerged as a new subtype of BC with distinct clinical, pathological, and prognostic features. Little is known about the prevalence of the HER2-low subtype in HER2-negative patients, and previous…
- Conditions
- Breast Neoplasms, Breast Cancer, Breast Carcinoma, Genes
- Trial name
- NCT06125314
- Where
- 7 sites in Kuwait, Qatar and 2 more
- Volunteers
- 517 people
- Sponsor
- AstraZeneca
Breast Neoplasms
Study of Disitamab Vedotin With Toripalimab Verus Disitamab Vedotin in Hormone Receptor Positive, HER2-low Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy, safety and tolerability of RC48-ADC with JS001 compared with RC48-ADC in endocrine-resistant hormone receptor (HR) positive, human epidermal growth factor receptor (HER)2-low advanced breast…
- Trial name
- NCT06105008
- Testing
- Disitamab Vedotin, Toripalimab
- Where
- 3 sites in China
- Sponsor
- RemeGen Co., Ltd.
HER2 Expressing Solid Tumors
Gene Therapy for HER-Positive Cancer (SENTRY-HER2)
This is a Phase 1/2, first-in-human, open-label, dose-escalating and expansion trial designed to assess the safety and efficacy of VNX-202 in patients with HER2 positive cancers.
- Trial name
- SENTRY-HER2 (NCT07192432)
- Testing
- Dose Level 1, VNX-202, Dose Level 2, VNX-202, Dose Level 3, VNX-202
- Where
- 11 sites in United States
- Volunteers
- 27 people
- Sponsor
- Vironexis Biotherapeutics Inc.
Breast Cancer
Therapeutic Cancer Vaccine (AST-301, pNGVL3-hICD) in Patients With Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of an adjuvant treatment of therapeutic cancer vaccine (AST-301, pNGVL3-hICD) in patients with HER2-low expression (IHC 1+ or 2+ and ISH-) and hormone…
- Trial name
- Cornerstone001 (NCT05163223)
- Testing
- AST-301(pNGVL3-hICD), rhuGM-CSF, Pembrolizumab
- Where
- 17 sites in United States, Taiwan
- Volunteers
- 10 people
- Sponsor
- Aston Sci. Inc.
Breast Cancer
A Study of BB-1701 in Previously Treated Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive or HER2-low Unresectable or Metastatic Breast Cancer
The primary purpose of the Dose Optimization (Part 1) of this study is to assess the safety and tolerability of BB-1701 and to determine the recommended dose (RD) of BB-1701 for Dose Expansion (Part 2).
- Trial name
- NCT06188559
- Testing
- BB-1701
- Where
- 49 sites in United States, France and 2 more
- Volunteers
- 56 people
- Sponsor
- Eisai Inc.
Breast Cancer
A Clinical Trial of TQB2102 for Injection in the Treatment of HER2 Low-Expressing Recurrent/Metastatic Breast Cancer
The study is a Phase III, randomized, multicenter, open-label study in HER2-low, HR+ metastatic breast cancer subjects who are patients with locally advanced or metastatic breast cancer with low HER2 expression in the recurrent…
- Trial name
- NCT06561607
- Testing
- TQB2102 for Injection, Chemotherapy drug (Capecitabine/Paclitaxel/Albumin Paclitaxel)
- Where
- 34 sites in China
- Volunteers
- 542 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
HER2 Positive Breast Cancer
A Study of Tucatinib vs. Placebo in Combination With Capecitabine & Trastuzumab in Patients With Advanced HER2+ Breast Cancer
This study is being done to see if tucatinib works better than placebo to help patients who have a specific type of breast cancer called HER2 positive breast carcinoma.
- Trial name
- HER2CLIMB (NCT02614794)
- Testing
- tucatinib, capecitabine, trastuzumab
- Where
- 176 sites in United States, Australia and 13 more
- Volunteers
- 612 people
- Sponsor
- Seagen Inc.