Clinical trials: HER2-Positive Breast Cancer
Breast Neoplasms
Participant Preference of Subcutaneous (SC) Versus Intravenous (IV) Herceptin (Trastuzumab) in Human Epidermal Growth Factor Receptor (HER) 2-Positive Early Breast Cancer
This randomized, open-label, crossover study will evaluate participants' preference and healthcare professional (HCP) satisfaction with SC versus IV Herceptin administration in HER2-positive early breast cancer.
- Trial name
- PrefHER (NCT01401166)
- Testing
- Herceptin, Single-Use Injection Device
- Where
- 75 sites in Canada, Denmark and 10 more
- Volunteers
- 488 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
A Study of Herceptin (Trastuzumab) in Combination With a Taxane in Participants With HER2-Positive Breast Cancer Who Relapsed After (Neo)Adjuvant Herceptin Treatment
This single arm, open-label study will evaluate the efficacy and safety of Herceptin (trastuzumab) in combination with a taxane as first line therapy in participants with HER2-positive breast cancer who relapsed after neoadjuvant…
- Trial name
- NCT01301729
- Testing
- Docetaxel, Paclitaxel, Trastuzumab
- Where
- 17 sites in China
- Volunteers
- 32 people
- Sponsor
- Hoffmann-La Roche
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
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 of Eribulin Mesylate With Trastuzumab for Advanced or Recurrent Human Epidermal Growth Factor Receptor 2-Positive (HER2+) Breast Cancer
The purpose of the study is to evaluate dose limiting toxicity (DLT), investigate the tolerability and safety of eribulin mesylate with trastuzumab combination therapy, and estimate the recommended dose.
- Trial name
- NCT01432886
- Testing
- E7389
- Where
- 2 sites in Japan
- Volunteers
- 12 people
- Sponsor
- Eisai Co., Ltd.
Metastatic Breast Cancer
A Study of Pertuzumab With High-Dose Trastuzumab for the Treatment of Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (MBC) With Central Nervous System (CNS) Progression Post-Radiotherapy
This study will examine the safety and efficacy of pertuzumab in combination with high-dose trastuzumab in adult participants with HER2-positive MBC with CNS metastases and disease progression in the brain following radiotherapy.
- Trial name
- NCT02536339
- Testing
- Pertuzumab, Trastuzumab
- Where
- 16 sites in United States
- Volunteers
- 40 people
- Sponsor
- Genentech, Inc.
Early Breast Cancer
A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer
This is a global Phase III, two-arm, open-label, multicenter, randomized study to investigate the pharmacokinetics, efficacy, and safety of the fixed-dose combination (FDC) of pertuzumab and trastuzumab for subcutaneous (SC)…
- Trial name
- FeDeriCa (NCT03493854)
- Testing
- Cyclophosphamide, Doxorubicin, Docetaxel
- Where
- 107 sites in United States, Argentina and 17 more
- Volunteers
- 500 people
- Sponsor
- Hoffmann-La Roche
Unrespectable Locally Advanced and or Metastatic HER2 Positive Breast Cancer Participants
JSKN003 Versus Trastuzumab Emtansine (T-DM1) for HER2-Positive, Advanced Breast Cancer
This study is designed to compare the safety and efficacy of JSKN003 versus T-DM1 in unrespectable locally advanced and/or metastatic HER2-positive breast cancer participants previously treated with trastuzumab and taxane.
- Trial name
- NCT06846437
- Testing
- JSKN003, Trastuzumab emtansine (T-DM1)
- Where
- China
- Volunteers
- 228 people
- Sponsor
- Shanghai JMT-Bio Inc.
Neoplasms, Breast
ALTTO (Adjuvant Lapatinib And/Or Trastuzumab Treatment Optimisation) Study; BIG 2-06/N063D
This was a four-arm (parallel group) randomized, open-label, multicenter Phase 3 study to investigate the use of a combination of Lapatinib and Trastuzumab, a sequence of Trastuzumab followed by Lapatinib, and Lapatinib alone…
- Trial name
- ALTTO (NCT00490139)
- Testing
- Lapatinib, Trastuzumab
- Where
- 924 sites in United States, Argentina and 42 more
- Volunteers
- 8,381 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer
The primary objective of Phase 1b will be to evaluate the safety and tolerability of TTI-101 when added to palbociclib and AI or fulvestrant administered orally to participants with hormone receptor-positive (HR+) human epidermal…
- Trial name
- NCT05384119
- Testing
- TTI-101, Palbociclib, Aromatase inhibitor (AI)
- Where
- 6 sites in United States
- Volunteers
- 6 people
- Sponsor
- Tvardi Therapeutics, Incorporated
Her2 Negative Breast Cancer Patients
Trial of Exemestane +/- MM-121 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive and/or Progesterone Receptor Positive Her2 Negative Breast Cancer
To determine whether the combination MM-121 + Exemestane in ER+ and/or PR+ breast cancer patients is more effective than Exemestane alone
- Trial name
- NCT01151046
- Testing
- MM-121, Exemestane
- Where
- 33 sites in United States, Canada and 3 more
- Volunteers
- 118 people
- Sponsor
- Merrimack Pharmaceuticals
Breast Neoplasms
Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer
This study evaluated and compared the efficacy and tolerability of lapatinib and letrozole, with letrozole and placebo in post-menopausal women with hormone receptor positive (ER positive and/or PgR positive) advanced or…
- Trial name
- NCT00073528
- Testing
- Lapatinib, Letrozole
- Where
- 278 sites in United States, Argentina and 27 more
- Volunteers
- 1,286 people
- Sponsor
- Novartis Pharmaceuticals
HER2 + Breast Cancer
A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer
The study is being conducted to evaluate the clinical efficacy of HLX22 in combination with HLX87 as first-line treatment in patients with HER2-positive recurrent or metastatic breast cancer
- Trial name
- NCT07294508
- Testing
- HLX87 + HLX22, HLX87 + Pertuzumab, T-Dxd + Pertuzumab
- Where
- China
- Volunteers
- 706 people
- Sponsor
- Shanghai Henlius Biotech
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.
HER-2-positive Advanced Breast Cancer
Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody (GB221) for Injection
The primary objective of this trial is to compare the progression-free survival (PFS) in two groups of combined therapy of GB221/ capecitabine tablets versus combined therapy of placebo/capecitabine tablets; the secondary…
- Trial name
- NCT04164615
- Testing
- GB221
- Where
- China
- Volunteers
- 336 people
- Sponsor
- Genor Biopharma Co., Ltd.
HER2-positive Breast Cancer
An Expanded Access Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Patients With HER2-Positive Breast Cancer During the COVID-19 Pandemic
This single arm, multicenter study provides the pertuzumab and trastuzumab fixed-dose combination formulation for subcutaneous injection (PH FDC SC) administered at home by a home health nursing provider for patients with human…
- Trial name
- NCT04395508
- Testing
- Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC)
- Where
- 12 sites in United States
- Sponsor
- Genentech, Inc.
Neoplasms, Breast
Safety and Immunogenicity Study of the New dHER2 Vaccine to Treat HER2-positive Metastatic Breast Cancer
Patients will receive a maximum of 18 injections of dHER2 vaccine in a treatment schedule that will last for up to about a year, and thereafter there will be a follow-up period of about one more year.
- Trial name
- NCT00140738
- Testing
- GSK Biologicals' 719125
- Where
- 14 sites in Belgium, Colombia and 3 more
- Volunteers
- 3 people
- Sponsor
- GlaxoSmithKline
Breast Cancer
A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)
Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug.
- Trial name
- NCT03248492
- Testing
- DS-8201a
- Where
- 99 sites in United States, Belgium and 7 more
- Volunteers
- 253 people
- Sponsor
- Daiichi Sankyo
Breast Neoplasms
A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
The main purpose of this study is to compare progression-free survival for women with hormone receptor positive (HR+), human epidermal growth factor receptor (HER2) negative advanced breast cancer receiving either abemaciclib +…
- Trial name
- MONARCH 2 (NCT02107703)
- Testing
- Abemaciclib, Fulvestrant
- Where
- 146 sites in United States, Australia and 18 more
- Volunteers
- 669 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
Study of ISB 1302 (CD3 Bispecific Ab) in HER2-positive Metastatic Breast Cancer
The purpose of this study is to determine the safety profile, maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single agent ISB1302 in subjects with HER2-positive metastatic breast cancer who have been…
- Trial name
- NCT03983395
- Testing
- ISB 1302 250 ng/kg, ISB 1302 325 ng/kg, ISB 1302 325 ng/kg-D1;425 ng/kg -D8,D15,D22
- Where
- 5 sites in United States
- Volunteers
- 1 people
- Sponsor
- Ichnos Sciences SA