Clinical trials: HER2 Positive Metastatic Breast Cancer
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
Female Breast Carcinoma, Breast Cancer
Trial of Anastrozole and Palbociclib in Metastatic HER2-Negative Breast Cancer
This is an open-label, pilot study designed to evaluate the safety and feasibility of combining anastrozole and palbociclib in the following two cohorts: Cohort A) as first-line therapy and Cohort B) as maintenance therapy after…
- Trial name
- NCT02942355
- Testing
- anastrozole, Palbociclib
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Wake Forest University Health Sciences
Breast Cancer
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
HER2-targeted therapy after the failure of trastuzumab treatment has become a new difficulty and challenge. Inetetamab, a new antibody to optimize the ADCC effect, has become one of the second-line treatment options after…
- Trial name
- NCT04681911
- Testing
- Inetetamab, Pyrotinib, Capecitabine
- Where
- China
- Volunteers
- 71 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Primary Non-metastatic Breast Cancer, Who Remain Disease-free
Safety Study of Adding Everolimus to Adjuvant Hormone Therapy in Women With High Risk of Relapse, ER+ and HER2- Primary Breast Cancer, Free of Disease After Receiving at Least One Year of Adjuvant Hormone Therapy
A significant number of patients relapse and eventually die, particularly if they were initially diagnosed with large nodes involvement and/or T3/4 diseases.
- Trial name
- NCT01805271
- Testing
- Everolimus
- Where
- 2 sites in France
- Volunteers
- 1,278 people
- Sponsor
- UNICANCER
HER-2 Positive Breast Cancer
PETRA: PErtuzumab and Trastuzumab Biosimilars Real Life Association for the First Line Treatment of HER2-positive Metastatic Breast Cancer, an Observational Prospective Multicenter Study
Currently there are five trastuzumab biosimilars approved by EMA (Ogivri® Mylan , Herzuma® Biogaran, Ontruzant® MSD, Trazimera® Pfizer, and Kanjinti® Amgen) for the treatment of HER2-positive breast cancer.
- Trial name
- PETRA (NCT04644406)
- Testing
- Efficacy of the Pertuzumab-Trastuzumab combination
- Where
- 6 sites in France
- Volunteers
- 200 people
- Sponsor
- Hospices Civils de Lyon
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 Positive Breast Carcinoma, Recurrent Breast Carcinoma
4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer
This trial studies the best dose and side effects of utomilumab (4-1BB agonist monoclonal antibody PF-05082566) with trastuzumab emtansine or trastuzumab in treating patients with HER2-positive breast cancer that has spread to…
- Conditions
- HER2 Positive Breast Carcinoma, Recurrent Breast Carcinoma, Stage III Breast Cancer, Stage IIIA Breast Cancer
- Trial name
- NCT03364348
- Testing
- Utomilumab, Trastuzumab, Ado-Trastuzumab Emtansine
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- George W. Sledge Jr.
Tubular Breast Cancer Stage II, Mucinous Breast Cancer Stage II
Nanoparticle-based Paclitaxel vs Solvent-based Paclitaxel as Part of Neoadjuvant Chemotherapy for Early Breast Cancer (GeparSepto)
Current guidelines as those from the AGO-Breast commission recommend for neoadjuvant breast cancer patients either a sequence of 4 cycles EC followed by 4 cycles of a taxane or 6 cycles of TAC based on previous large scale…
- Conditions
- Tubular Breast Cancer Stage II, Mucinous Breast Cancer Stage II, Breast Cancer Female NOS, Invasive Ductal Breast Cancer
- Trial name
- GeparSepto (NCT01583426)
- Testing
- nab-Paclitaxel, Paclitaxel
- Where
- Germany
- Volunteers
- 1,229 people
- Sponsor
- GBG Forschungs GmbH
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.
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
HER2-positive Breast Cancer
Maintenance Therapy in HER2-Positive Unresectable Locally Recurrent or Metastatic Breast Cancer: A Phase II Study
This is a phase II trial exploring the maintenance therapy with trastuzumab combined with pyrotinib or dalpiciclib and endocrine therapy in HER2-positive advanced breast cancer based on different hormone receptor (HR) statuses…
- Trial name
- NCT07179939
- Testing
- Trastuzumab rezetecan, Pyrotinib, Dalpiciclib
- Where
- China
- Volunteers
- 288 people
- Sponsor
- Fudan University
Breast Cancer
Vinorelbine Plus (+) Trastuzumab vs Docetaxel Plus (+) Trastuzumab as 1 Line Treatment for HER2 Positive (+) Metastatic Breast Cancer
In an open-label randomised phase III-trial patients with metastatic HER2-positive breast cancer naive to chemotherapy with normal organ function and WHO performance status < 3 are randomised to receive either docetaxel 100 mg/m2…
- Trial name
- NCT00430001
- Testing
- docetaxel, vinorelbine, trastuzumab
- Where
- Denmark
- Volunteers
- 300 people
- Sponsor
- Danish Breast Cancer Cooperative Group
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 Cancer
ARX788 in HER2-positive Metastatic Breast Cancer Patients Who Were Previously Treated With T-DXd
A single arm, phase 2 Study of ARX788 in HER2-positive metastatic breast cancer patients who were previously treated with T-DXd. The ARX788 will be administered every 3 weeks (Q3W) intravenous (IV) infusion.
- Trial name
- NCT06578286
- Testing
- ARX788
- Volunteers
- 44 people
- Sponsor
- Fudan University
Estrogen Receptor Positive, HER2/Neu Negative
RO4929097 And Exemestane in Treating Pre- and Postmenopausal Patients With Advanced or Metastatic Breast Cancer
This partially randomized phase I trial is studying the side effects and the best dose of RO4929097 when given together with exemestane and to see how well it works compared to exemestane alone in treating premenopausal and…
- Conditions
- Estrogen Receptor Positive, HER2/Neu Negative, Male Breast Carcinoma, Recurrent Breast Carcinoma
- Trial name
- NCT01149356
- Testing
- Exemestane, Gamma-Secretase Inhibitor RO4929097, Goserelin Acetate
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- National Cancer Institute (NCI)
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
Advanced Breast Cancer
Efficacy and Safety of Trastuzumab Rezetecan or Trastuzumab Deruxtecan in Advanced Breast Cancer
This study is a prospective, open-label, multicenter, randomized, parallel Phase II clinical trial. This study aims to investigate the efficacy and safety of trastuzumab rezetecan or trastuzumab deruxtecan in HER2 positive…
- Trial name
- NCT07630103
- Testing
- Trastuzumab Rezetecan for Injection (SHR-A1811), Trastuzumab Deruxtecan for Injection (T-DXd)
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
HER2-positive Breast Cancer
PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer
DEMETHER is a phase II trial exploring the maintenance of trastuzumab and pertuzumab fixed dose combination (FDC) for subcutaneous administration (SC, PHESGO) following trastuzumab deruxtecan (T-DXd) as induction treatment for…
- Trial name
- DEMETHER (NCT06172127)
- Testing
- Trastuzumab deruxtecan, Phesgo 1,200 MG / 600 MG / 30,000 UNT Per 15 ML Injection, Phesgo 600 MG / 600 MG / 20,000 UNT in 10 mL Injection
- Where
- 36 sites in United States, France and 3 more
- Volunteers
- 165 people
- Sponsor
- MedSIR