Clinical trials: HER2 Mutation
NSCLC, Stage IV, NSCLC Stage IIIB
Study of Tarloxotinib in Pts With NSCLC (EGFR Exon 20 Insertion, HER2-activating Mutations) & Other Solid Tumors With NRG1/ERBB Gene Fusions
Open-label, Phase 2, single treatment arm, 3 cohorts
- Conditions
- NSCLC, Stage IV, NSCLC Stage IIIB, NSCLC, Stage IIIC, NSCLC, Recurrent
- Trial name
- RAIN (NCT03805841)
- Testing
- tarloxotinib bromide
- Where
- 14 sites in United States, Canada and 1 more
- Volunteers
- 41 people
- Sponsor
- Rain Oncology Inc
Metastatic Breast Cancer
A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer
The primary objective of the study is to assess the progression-free survival (PFS) of veliparib in combination with carboplatin and paclitaxel (C/P) compared to placebo plus C/P in participants with a Breast Cancer Gene 1 or 2…
- Trial name
- NCT02163694
- Testing
- Veliparib, Carboplatin, Paclitaxel
- Where
- 219 sites in United States, Argentina and 35 more
- Volunteers
- 513 people
- Sponsor
- AbbVie
Metastatic Breast Cancer, Breast Neoplasms
Treatment Patterns and Clinical Outcomes Among Talazoparib-Treated Adults With HER2-Negative mBC With gBRCA1/2m
This non-interventional retrospective study will describe real-world treatment patterns and clinical outcomes among adults with HER2-negative metastatic breast cancer with germline BRCA1/2 mutations who initiated talazoparib as a…
- Trial name
- NCT05141708
- Testing
- Talazoparib
- Where
- United States
- Volunteers
- 33 people
- Sponsor
- Pfizer
Non-Small Cell Lung Cancer
Trastuzumab Deruxtecan in Participants With HER2-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)
This study was designed to evaluate the safety and efficacy of trastuzumab deruxtecan in HER2-mutated metastatic non-small cell lung cancer (NSCLC) participants who had disease recurrence or progression during/after at least one…
- Trial name
- DESTINY-LUNG02 (NCT04644237)
- Testing
- Trastuzumab deruxtecan
- Where
- 50 sites in United States, Australia and 8 more
- Volunteers
- 152 people
- Sponsor
- Daiichi Sankyo
HER2-mutant Non-Small Cell Lung Cancer
Neratinib With and Without Temsirolimus for Patients With HER2 Activating Mutations in Non-Small Cell Lung Cancer
This is a Phase 2, therapeutic-exploratory, adaptive design, open-label, multicenter, multinational study evaluating neratinib monotherapy and neratinib plus temsirolimus combination therapy in patients with non-small cell lung…
- Trial name
- NCT01827267
- Testing
- neratinib, temsirolimus
- Where
- 21 sites in United States, France
- Volunteers
- 62 people
- Sponsor
- Puma Biotechnology, Inc.
Advanced or Metastatic Breast Cancer
MEN1611 With Trastuzumab (+/- Fulvestrant) in Metastatic Breast Cancer
The main purpose of this open-label, dose-escalation, phase Ib study is to identify the appropriate dose of MEN1611 to be used in combination with Trastuzumab with/without Fulvestrant for the treatment of advanced or metastatic…
- Trial name
- B-PRECISE-01 (NCT03767335)
- Testing
- MEN1611, Trastuzumab, Fulvestrant
- Where
- 27 sites in United States, Belgium and 4 more
- Volunteers
- 62 people
- Sponsor
- Menarini Group
Early Breast Cancer
Talazoparib For Neoadjuvant Treatment Of Germline BRCA1/2 Mutation Patients With Early Human Epidermal Growth Factor Receptor 2 Negative Breast Cancer
A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY HUMAN EPIDERMAL GROWTH FACTOR RECEPTOR 2 NEGATIVE BREAST CANCER
- Trial name
- NCT03499353
- Testing
- TALAZOPARIB
- Where
- 97 sites in United States
- Volunteers
- 61 people
- Sponsor
- Pfizer
Advanced Solid Tumors With HER2 Mutation,eg:Colorectal,Urothelial,Gastric, Hepatobiliary,Endometrial,Melanoma,Ovarian,Cervical,Salivary Gland,Pancreatic,Breast
A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations
This is an open-label, multi-center, single arm, Phase II study to evaluate the efficacy and safety of T-DXd for the treatment of unresectable and/or metastatic solid tumors harboring specific HER2 activating mutations regardless…
- Trial name
- DPT01 (NCT04639219)
- Testing
- Trastuzumab deruxtecan
- Where
- 30 sites in United States, Belgium and 7 more
- Volunteers
- 102 people
- Sponsor
- AstraZeneca
Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
Basket Study of Neratinib in Participants With Solid Tumors Harboring Somatic HER2 or EGFR Exon 18 Mutations
This is an open-label, multicenter, multinational, Phase 2 basket study exploring the efficacy and safety of neratinib as monotherapy or in combination with other therapies in participants with HER (EGFR, HER2) mutation-positive…
- Trial name
- SUMMIT (NCT01953926)
- Testing
- Neratinib, Fulvestrant, Trastuzumab
- Where
- 60 sites in United States, Australia and 11 more
- Volunteers
- 582 people
- Sponsor
- Puma Biotechnology, Inc.
Breast Cancer
Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer
Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy
- Trial name
- OlympiA (NCT02032823)
- Testing
- Olaparib
- Where
- 698 sites in United States, Argentina and 22 more
- Volunteers
- 1,837 people
- Sponsor
- AstraZeneca
Neoplasms, Breast, Carcinoma of Breast
A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
The purpose of this study is to compare progression-free survival (PFS) in patients with advanced/metastatic breast cancer who have a BRCA mutation when treated with niraparib as compared to those treated with physician's choice
- Conditions
- Neoplasms, Breast, Carcinoma of Breast, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, BRCA1 Gene Mutation
- Trial name
- BRAVO (NCT01905592)
- Testing
- niraparib, Physician's choice
- Where
- 104 sites in United States, Belgium and 12 more
- Volunteers
- 216 people
- Sponsor
- Tesaro, Inc.
Non-Small Cell Lung Cancer
DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer
The primary objective of this trial is to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC participants.
- Trial name
- DESTINY-Lung01 (NCT03505710)
- Testing
- Trastuzumab deruxtecan
- Where
- 21 sites in United States, France and 3 more
- Volunteers
- 181 people
- Sponsor
- Daiichi Sankyo
Disease Progression
Treatment Resistance Following Anti-cancer Therapies
The TRANSLATE study aims to better understand why tumors become resistant to standard anti-cancer therapies. New tumor biopsy and blood samples are collected after disease progression on standard-of-care anti-cancer treatment and…
- Trial name
- NCT04436120
- Testing
- De novo tumor tissue biopsy, Research blood draws
- Where
- 33 sites in United States, Argentina and 3 more
- Volunteers
- 38 people
- Sponsor
- Pfizer
Breast Cancer Metastatic, BRCA 1 Gene Mutation
Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.
This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in…
- Conditions
- Breast Cancer Metastatic, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
- Trial name
- OlympiAD (NCT02000622)
- Testing
- Olaparib, Physician's choice chemotherapy
- Where
- 171 sites in United States, Bulgaria and 17 more
- Volunteers
- 302 people
- Sponsor
- AstraZeneca
NSCLC, Breast Cancer
A Study to Allow Continued Dosing and/or Follow-up of Patients Who Have Had Previous Exposure to Poziotinib
This is an open-label extension study (Extension Study) designed to allow patients to continue to receive poziotinib treatment who have had previous exposure to poziotinib and/or are still receiving clinical benefit from…
- Trial name
- NCT03744715
- Testing
- Poziotinib
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
NSCLC
Study of Poziotinib in Japanese Patients With NSCLC
A Phase 1/2, open-label, multicenter study to determine dose, tolerability, safety and efficacy of poziotinib in Japanese patients non-small cell lung cancer (NSCLC).
- Trial name
- NCT04402008
- Testing
- Poziotinib Once Daily Dosing, Poziotinib Twice Daily Dosing, Poziotinib Once Daily Dosing or Twice Daily Dosing as determined in Phase 1
- Where
- 3 sites in Japan
- Volunteers
- 42 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Breast Cancer, Colorectal Cancer
A Study of Poziotinib in Patients With Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Activating Mutations in Advanced Malignancies
This is a Phase 2, open-label, multicenter study whose principal objectives are to evaluate the efficacy and safety/tolerability of poziotinib in five cohorts of 30 previously-treated patients each.
- Conditions
- Breast Cancer, Colorectal Cancer, Solid Tumor, Glioblastome Multiforme
- Trial name
- NCT04172597
- Testing
- Poziotinib Hydrochloride, Loperamide
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Spectrum Pharmaceuticals, Inc
Neoplasms, Breast
Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease
This study will assess the efficacy and safety of Niraparib in participants with either tumor mutation in the BRCA gene (tBRCAmut) HER2- breast cancer (Independent of hormone receptor [HR] status, including HR positive [+] and…
- Trial name
- ZEST (NCT04915755)
- Testing
- Niraparib
- Where
- 198 sites in United States, Argentina and 25 more
- Volunteers
- 40 people
- Sponsor
- GlaxoSmithKline
Neoplasms
Phase II Trial of BIBW 2992 (Afatinib) in Genetically Pre-screened Cancers With EGFR and/or HER2 Gene Amplification.
This is a Phase II open-label exploratory trial of BIBW 2992 administered to patients with tumors of various histologies found to possess EGFR and/or HER2 gene amplification, or EGFR activating mutations.
- Trial name
- NCT00748709
- Testing
- BIBW 2992 (Afatinib)
- Where
- 15 sites in United States, Taiwan
- Volunteers
- 20 people
- Sponsor
- Boehringer Ingelheim
Carcinoma, Non-Small-Cell Lung
Afatinib in NSCLC With HER2 Mutation
to investigate effectiveness and safety of afatinib in the advanced NSCLC patients with HER2 mutations, previously treated with 1 or 2 chemotherapy regimens
- Trial name
- NCT02597946
- Testing
- afatinib, paclitaxel
- Where
- 9 sites in China, Malaysia
- Volunteers
- 18 people
- Sponsor
- Boehringer Ingelheim