Clinical trials: HER2-positive Advanced Breast Cancer
Breast Neoplasms
A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer
This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line…
- Trial name
- PERUSE (NCT01572038)
- Testing
- Docetaxel, Nab-paclitaxel, Paclitaxel
- Where
- 299 sites in Algeria, Argentina and 37 more
- Volunteers
- 1,436 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Study in Participants With Early-Stage or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer to Evaluate Treatment With Trastuzumab Plus (+) Pertuzumab + Docetaxel Compared With Trastuzumab + Placebo + Docetaxel
This is an Asia-Pacific regional, randomized, double-blind, multicenter trial designed to evaluate treatment with trastuzumab + pertuzumab + docetaxel compared with trastuzumab + placebo + docetaxel in chemotherapy-naïve…
- Trial name
- PEONY (NCT02586025)
- Testing
- FEC Chemotherapy, Surgery, Docetaxel
- Where
- 23 sites in China, South Korea and 2 more
- Volunteers
- 329 people
- Sponsor
- Hoffmann-La Roche
Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Adenocarcinoma
Study to Assess GTAEXS617 in Participants With Advanced Solid Tumors
The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617 (REC-617) in participants with advanced solid tumors.
- Conditions
- Head and Neck Squamous Cell Carcinoma (HNSCC), Pancreatic Adenocarcinoma, Non-small Cell Lung Cancer (NSCLC), Platinum-resistant High-grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers (HGSOC)
- Trial name
- ELUCIDATE (NCT05985655)
- Testing
- GTAEXS617, SoC
- Where
- 15 sites in United States, Belgium and 1 more
- Volunteers
- 230 people
- Sponsor
- Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
Neoplasms, Breast
Study of Lapatinib in Breast Cancer Patients With HER-2 Non-amplified Primary Tumors and HER-2 Positive or EGFR Positive Circulating Tumor Cells
The underlying biology of the various patterns of metastasis observed in different tumour types remains unclear. The detection and characterization of circulating tumour cells in cancer patients has provided important new…
- Trial name
- NCT00820924
- Testing
- LAPATINIB
- Where
- 10 sites in Italy, United Kingdom
- Volunteers
- 23 people
- Sponsor
- GlaxoSmithKline
Advanced ER-Positive HER2-Negative Breast Cancer
A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer
This study is randomized, open-label, parallel-group, multicentre Phase 2 study aimed to compare the efficacy and safety of oral AZD9833 versus intramuscular (IM) fulvestrant in women with advanced breast cancer.
- Trial name
- SERENA-2 (NCT04214288)
- Testing
- AZD9833, Fulvestrant
- Where
- 85 sites in United States, Belgium and 14 more
- Volunteers
- 240 people
- Sponsor
- AstraZeneca
Breast Cancer
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
This is a Phase III, multicenter, randomized, open-label, global study designed to evaluate the efficacy and safety of inavolisib plus fulvestrant compared with alpelisib plus fulvestrant in patients with hormone receptor…
- Trial name
- INAVO121 (NCT05646862)
- Testing
- Inavolisib, Fulvestrant, Alpelisib
- Where
- 210 sites in United States, Argentina and 18 more
- Volunteers
- 420 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
FS-1502 Versus T-DM1 for HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer
This study is designed to compare the anti-tumor activity as well as the safety and efficacy of FS-1502 versus T-DM1 in HER2-positive, unresectable locally advanced or metastatic breast cancer subjects previously treated with…
- Trial name
- NCT05755048
- Testing
- Investigational drug: Recombinant Anti-HER2 Humanized Monoclonal Antibody - Monomethyl Auristatin F Conjugates for Injection (FS-1502), Control drug: Trastuzumab emtansine (Kadcyla, T-DM1)
- Where
- 56 sites in China
- Volunteers
- 314 people
- Sponsor
- Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
Advanced Breast Cancer
A Study of RC48-ADC in Subjects With Advanced Breast Cancer
This study will evaluate the efficacy, safety and pharmacokinetics of RC48-ADC for injection in subjects with advanced breast cancer with HER2 positive or HER2 low expression
- Trial name
- NCT03052634
- Testing
- RC48-ADC 1.5 mg/kg (HER2 Positive), RC48-ADC 2.0 mg/kg (HER2 Positive), RC48-ADC 2.5 mg/kg (HER2 Positive)
- Where
- 7 sites in China
- Volunteers
- 112 people
- Sponsor
- RemeGen Co., Ltd.
Breast Cancer
Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients
This is a multi-center, two-cohorts, phase IIIb study of Capivasertib+Fulvestrant in HR+/HER2-ABC who had disease recurrence/progression following 1-2L endocrine therapy.
- Trial name
- CAPItrue (NCT06635447)
- Testing
- Capivasertib, Fulvestrant
- Where
- 76 sites in China
- Volunteers
- 293 people
- Sponsor
- AstraZeneca
Chordoma, HER2-positive Breast Cancer
TAEK-VAC-HerBy Vaccine for Brachyury and HER2 Expressing Cancer
A Phase 1 open label trial of intravenous administration of TAEK-VAC-HerBy vaccine in patients with advanced brachyury and/or HER2- expressing cancer. The study will be completed in 2 stages.
- Trial name
- NCT04246671
- Testing
- TAEK-VAC-HerBy
- Where
- 9 sites in United States
- Volunteers
- 37 people
- Sponsor
- Bavarian Nordic
HER2-positive Breast Cancer, HER2-positive Biliary Tract Cancer
Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors
Phase I Dose Finding Study for GQ1001 in Patients with HER2-Positive Advanced Solid Tumors
- Conditions
- HER2-positive Breast Cancer, HER2-positive Biliary Tract Cancer, HER2-Positive Salivary Gland Carcinomas, HER2-Positive Advanced Solid Tumor
- Trial name
- NCT04450732
- Testing
- GQ1001
- Where
- 24 sites in United States, Australia and 1 more
- Volunteers
- 96 people
- Sponsor
- GeneQuantum Healthcare (Suzhou) Co., Ltd.
Locally Advanced or Metastatic Malignant Solid Tumors
A Study to Evaluate Enfortumab Vedotin in Subjects With Locally Advanced or Metastatic Malignant Solid Tumors (EV-202)
The primary purpose of this study is to determine the antitumor activity of enfortumab vedotin as measured by confirmed objective response rate (ORR) per RECIST v1.1.
- Trial name
- NCT04225117
- Testing
- enfortumab vedotin, pembrolizumab
- Where
- 39 sites in United States, Canada and 1 more
- Volunteers
- 329 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Breast Neoplasms
MM-111 in Combination With Herceptin in Patients With Advanced Her2 Amplified, Heregulin Positive Breast Cancer
This is an open-label Phase 1 trial of MM-111 in combination with Herceptin.
- Trial name
- NCT01097460
- Testing
- MM-111 + Herceptin
- Where
- 3 sites in United States
- Volunteers
- 16 people
- Sponsor
- Merrimack Pharmaceuticals
Breast Cancer
A Study of T-DXd in Participants With or Without Brain Metastasis Who Have Previously Treated Advanced or Metastatic HER2 Positive Breast Cancer
This is open-label, multicenter, international study, assessing the efficacy and safety of Trastuzumab deruxtecan (T-DXd) in participants with or without brain metastasis (BMs), with previously-treated advanced/metastatic…
- Trial name
- DESTINY-B12 (NCT04739761)
- Testing
- Trastuzumab Deruxtecan
- Where
- 81 sites in United States, Australia and 16 more
- Volunteers
- 506 people
- Sponsor
- AstraZeneca
Breast Cancer
Study Evaluating Hemay022 in Combination With Endocrine Therapy In Subjects With ER Positive and HER2 Positive Advanced Breast Cancer
The purpose of this study is to evaluate the safety and tolerability of Hemay022 combined with endocrine therapy in the treatment of ER and HER2-positive metastatic or advanced breast cancer, and to establish OTR (best tolerated…
- Trial name
- NCT03308201
- Testing
- Hemay022+exemestane, Hemay022+letrozole, Hemay022+ fulvestrant
- Where
- China
- Volunteers
- 55 people
- Sponsor
- Tianjin Hemay Pharmaceutical Co., Ltd
Advanced Breast Cancer, Breast Cancer
Study of Larotaxel in Combination With Weekly Herceptin® in Patients With HER2 Positive Metastatic Breast Cancer
The purpose of this study is to evaluate the anti-tumor activity of the combination of experimental drug (larotaxel) when combined with Herceptin® in patients with advanced breast cancer.
- Conditions
- Advanced Breast Cancer, Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT00387907
- Testing
- larotaxel (XRP9881), trastuzumab
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Sanofi
HER2-positive Breast Cancer, HER2-positive Gastric Cancer
BI-1607 in Combination with Trastuzumab in Subjects with HER2-positive Advanced Solid Tumors
HER2+ breast and gastric cancer patients' survival is significantly improved by trastuzumab alone or in combination with chemotherapy.
- Conditions
- HER2-positive Breast Cancer, HER2-positive Gastric Cancer, HER2-positive Metastatic Breast Cancer, Metastatic Gastroesophageal Junction Adenocarcinoma
- Trial name
- CONTRAST (NCT05555251)
- Testing
- BI-1607, Trastuzumab
- Where
- 6 sites in Germany, Spain and 1 more
- Volunteers
- 18 people
- Sponsor
- BioInvent International AB
Breast Cancer, Solid Tumors, Adult
First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
Study STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid…
- Trial name
- PIKALO-1 (NCT05768139)
- Testing
- STX-478, Fulvestrant, Ribociclib
- Where
- 65 sites in United States, Belgium and 7 more
- Volunteers
- 880 people
- Sponsor
- Eli Lilly and Company
Metastatic Breast Cancer
A Study of Trastuzumab Emtansine, Paclitaxel, and Pertuzumab in Patients With HER2-Positive, Locally Advanced or Metastatic Breast Cancer
This Phase Ib-IIa, multi-institutional, open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics and feasibility of trastuzumab emtansine (T-DM1) administered by intravenous (IV)…
- Trial name
- NCT00951665
- Testing
- paclitaxel, pertuzumab [Perjeta], trastuzumab emtansine [Kadcyla]
- Where
- 5 sites in United States
- Volunteers
- 107 people
- Sponsor
- Genentech, Inc.
Estrogen Receptor (ER)-Positive, HER2-negative, Locally Advanced or Metastatic Breast Cancer
A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer)
This Phase III, randomized, open-label, multicenter study will evaluate the efficacy and safety of giredestrant plus everolimus compared with the physician's choice of endocrine therapy plus everolimus in participants with…
- Trial name
- NCT05306340
- Testing
- Giredestrant, Exemestane, Fulvestrant
- Where
- 136 sites in United States, Argentina and 11 more
- Volunteers
- 373 people
- Sponsor
- Genentech, Inc.