Clinical trials: HER2+ Cancer
Breast Cancer
Validation of Molecular Diagnostic Assays to Detect Cancer Biomarkers in Blood & Primary Tumor in ER+/HER2- MBC
Conventional biopsy and surgical tumor resection are invasive procedures that capture only one instance of the progression of the tumor. However, the genome of tumor is not static, but it is constantly altered during treatment.
- Trial name
- NCT04480814
- Testing
- PIK3CA kit
- Where
- 4 sites in Greece
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Pharmassist Ltd
Locally Advanced or Metastatic Breast Cancer
A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer)
This Phase III, randomized, two-arm, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus Phesgo compared with Phesgo after induction therapy with Phesgo plus taxane in participants with human…
- Trial name
- NCT05296798
- Testing
- Phesgo, Giredestrant, Docetaxel
- Where
- 198 sites in United States, Argentina and 27 more
- Volunteers
- 922 people
- Sponsor
- Hoffmann-La Roche
Metastatic, Gastric or Gastro-oesophageal Junction, Cancer
Assess the Efficacy of AZD8931 in Combination With Paclitaxel Versus Paclitaxel Alone in Patients With Gastric Cancer
The purpose of the study is to assess the efficacy and safety and PK of AZD8931 plus paclitaxel versus paclitaxel alone in patients with metastatic, gastric or gastro-oesophageal junction, cancer.
- Trial name
- NCT01579578
- Testing
- AZD8931, Paclitaxel
- Where
- 15 sites in Germany, Japan and 3 more
- Volunteers
- 39 people
- Sponsor
- AstraZeneca
HR+/HER2- Locally Advanced, Metastatic Breast Cancer
Study of BEBT-209 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Patients With HR+/HER2- Locally Advanced or Metastatic Breast Cancer Who Have Progressed After Prior Endocrine Therapy
This study is a randomized, double-blind, multicenter, placebo-controlled Phase III clinical trial designed to evaluate the efficacy and safety of BEBT-209 in combination with fulvestrant in patients with HR+/HER2- locally…
- Trial name
- NCT06998108
- Testing
- BEBT-209 capsules, Fulvestrant Injection
- Where
- China
- Volunteers
- 330 people
- Sponsor
- BeBetter Med Inc
PIK3CA Mutation, HER2- Negative Breast Cancer
Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer
This is a global, multicenter, open-label, randomized Phase 3 study comparing the efficacy and safety of RLY-2608 (zovegalisib) + fulvestrant to capivasertib + fulvestrant for the treatment of patients with HR+/HER2- ABC with…
- Conditions
- PIK3CA Mutation, HER2- Negative Breast Cancer, Hormone Receptor Positive Tumor, Breast Cancer
- Trial name
- ReDiscover-2 (NCT06982521)
- Testing
- Zovegalisib, Capivasertib, Fulvestrant
- Where
- 243 sites in United States, Argentina and 25 more
- Volunteers
- 540 people
- Sponsor
- Relay Therapeutics, Inc.
Breast Cancer
A Study of Cardiac Safety in Patients With HER2 Positive Early Breast Cancer Treated With Herceptin
This is a single cohort observational safety study. All patients will be treated and monitored according to the local clinical practice.
- Trial name
- NCT01152606
- Testing
- trastuzumab [Herceptin]
- Where
- 205 sites in Austria, Belgium and 7 more
- Volunteers
- 3,942 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety and Efficacy of Olaparib in Combination With Carboplatin in Patients With Advanced HER-2 Negative Breast Cancer
This is an open-label study to assess the safety, tolerability and efficacy of olaparib in combination with carboplatin. There are two parts in this study: Part A, a dose escalation in patients with advanced Human Epidermal…
- Trial name
- NCT02561832
- Testing
- Olaparib, Carboplatin, Anthracycline
- Where
- 7 sites in United States, Spain
- Volunteers
- 15 people
- Sponsor
- AstraZeneca
Metastatic Breast Cancer
A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi
This study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to determine the efficacy and safety of treatment with Buparlisib plus Fulvestrant vs.
- Trial name
- BELLE-3 (NCT01633060)
- Testing
- Fulvestrant, BKM120
- Where
- 197 sites in United States, Argentina and 20 more
- Volunteers
- 432 people
- Sponsor
- Novartis Pharmaceuticals
Urothelial Carcinoma
A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer
This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with HER2 overexpressing locally advanced or metastatic urothelial cancer.
- Trial name
- NCT03809013
- Testing
- RC48-ADC
- Where
- 8 sites in China
- Volunteers
- 64 people
- Sponsor
- RemeGen Co., Ltd.
Breast Cancer
Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer
The purpose of this research study is to compare the efficacy and safety of EG12014 with Herceptin as neoadjuvant treatment for 12 weeks, followed by surgery and subsequent EG12014 or Herceptin adjuvant treatment for up to 12…
- Trial name
- NCT03433313
- Testing
- EG12014, Herceptin
- Where
- 91 sites in United States, Belarus and 9 more
- Volunteers
- 807 people
- Sponsor
- EirGenix, Inc.
Metastatic Breast Cancer
Trastuzumab and Trastuzumab-MCC-DM1 Administered Intravenously and GDC-0941 Administered Orally to Patients With HER2-Positive Metastatic Breast Cancer Who Have Progressed on Previous Trastuzumab-Based Therapy
This multicenter, Phase Ib study is an open label, dose escalation, three-arm study evaluating the safety, tolerability, pharmacokinetics, and activity of oral (PO) GDC 0941 administered in combination with either intravenous…
- Trial name
- NCT00928330
- Testing
- GDC-0941, Trastuzumab, trastuzumab-MCC-DM1
- Where
- 3 sites in United States
- Volunteers
- 57 people
- Sponsor
- Genentech, Inc.
Melanoma (Excluding Uveal Melanoma), Cervical Carcinoma
A Study of XmAb®23104 in Subjects With Selected Advanced Solid Tumors (DUET-3)
This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb23104, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity…
- Conditions
- Melanoma (Excluding Uveal Melanoma), Cervical Carcinoma, Pancreatic Carcinoma, Breast Carcinoma That is Estrogen Receptor, Progesterone Receptor, and Her2 Negative
- Trial name
- DUET-3 (NCT03752398)
- Testing
- XmAb®23104, Yervoy® (ipilimumab)
- Where
- 18 sites in United States
- Volunteers
- 198 people
- Sponsor
- Xencor, Inc.
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Participants With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer
This study will evaluate the efficacy, safety, and pharmacokinetics of inavolisib in combination with palbociclib and fulvestrant compared with placebo plus palbociclib and fulvestrant in participants with PIK3CA-mutant, hormone…
- Trial name
- INAVO120 (NCT04191499)
- Testing
- Inavolisib, Palbociclib, Fulvestrant
- Where
- 135 sites in United States, Argentina and 26 more
- Volunteers
- 325 people
- Sponsor
- Hoffmann-La Roche
Breast Neoplasms, Carcinoma, Ductal, Breast
Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4/6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as "Signatera Genome") in participants with…
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Breast, Receptors, Estrogen (for ER-positive Requirement)
- Trial name
- SIGNAL-ER 101 (NCT07214532)
- Testing
- ctDNA-Guided Treatment Strategy
- Where
- 49 sites in United States
- Volunteers
- 725 people
- Sponsor
- Natera, Inc.
Breast Cancer
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2…
- Trial name
- NCT06757634
- Testing
- Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole
- Where
- 239 sites in United States, Argentina and 23 more
- Volunteers
- 1,180 people
- Sponsor
- Celcuity Inc
Neoplasm Metastasis
Study of DS-8201a for Participants With Advanced Solid Malignant Tumors
HER2-positive cancer is a cancer that tests positive for a protein called human epidermal growth factor receptor 2 (HER2). HER2 promotes the growth of certain cancer cells.
- Trial name
- NCT03383692
- Testing
- DS-8201a, Ritonavir, Itraconazole
- Where
- 10 sites in Japan, South Korea and 1 more
- Volunteers
- 40 people
- Sponsor
- Daiichi Sankyo Co., Ltd.
Breast Cancer
A Study to Learn About Vepdegestrant When Given With PF-07220060 to People With Advanced or Metastatic Breast Cancer.
The purpose of this study is to learn about the safety and effects of giving vepdegestrant along with PF-07220060. Vepdegestrant is studied to see if it can be a possible treatment for advanced metastatic breast cancer.
- Trial name
- NCT06206837
- Testing
- vepdegestrant, PF-07220060
- Where
- 58 sites in United States, Belgium and 6 more
- Volunteers
- 71 people
- Sponsor
- Pfizer
Metastatic Breast Cancer
BEZ235 Trial in Patients With HER2-(Human Epidermal Growth Factor Receptor 2 Negative) /HR+ (Hormonal Receptor Positive) Metastatic Breast Cancer
This is a prospective, multi-center, open-label, single arm, phase II study with a 2-stage design and Bayesian interim monitoring to investigate the safety and efficacy of BEZ235 in patients with progressive metastatic HR+ HER2…
- Trial name
- NCT01288092
- Testing
- BEZ235
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study of Bevacizumab (Avastin) in Combination With Neoadjuvant Treatment Regimens in Participants With Primary Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer
This study will evaluate the effect of bevacizumab in combination with chemotherapy or endocrine therapy, as preoperative treatment, in participants with HER2 negative breast cancer.
- Trial name
- NCT00773695
- Testing
- Aromatase Inhibitor, Bevacizumab, Epirubicine
- Where
- 3 sites in Norway
- Volunteers
- 150 people
- Sponsor
- Hoffmann-La Roche
HER2-positive Advanced Breast Cancer
TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer
TQB2930 is a HER2 bispecific antibody drug. This study aims to evaluate the efficacy and safety of TQB2930 combined with investigator's choice of chemotherapy versus trastuzumab combined with investigator's choice of chemotherapy…
- Trial name
- NCT07047365
- Testing
- TQB2930+ chemotherapy, Trastuzumab+ chemotherapy
- Where
- 75 sites in China
- Volunteers
- 416 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.