Clinical trials: HER2-Positive Breast Cancer
Metastatic Breast Cancer
Open-label Study of Safety, Tolerability and Pharmacokinetics of Multiple Doses of BI-CON-02 in Patients With HER2-positive Metastatic Breast Cancer, Previously Treated With Trastuzumab
This study will evaluate the safety and tolerability of BI-CON-02 in patients with HER2-positive metastatic breast cancer, previously treated with trastuzumab The clinical trial protocol for BI-CON-02 prescribes a start dose of…
- Trial name
- NCT03062007
- Testing
- BI-CON-02
- Where
- 6 sites in Russia
- Volunteers
- 6 people
- Sponsor
- Biointegrator LLC
HER2-positive Breast Cancer, Breast Cancer
A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer
- Trial name
- EmpowHER 208 (NCT07102381)
- Testing
- Zanidatamab, Paclitaxel, Docetaxel
- Where
- 53 sites in United States, Germany and 2 more
- Volunteers
- 125 people
- Sponsor
- Jazz Pharmaceuticals
Breast Cancer
A Study Evaluating Pertuzumab (Perjeta) Combined With Trastuzumab (Herceptin) and Standard Anthracycline-based Chemotherapy in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced, Inflammatory, or Early-stage Breast Cancer
This multicenter, non-randomized, open-label, phase 2 study is designed to evaluate the safety and efficacy of pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and anthracycline-based chemotherapy as neoadjuvant…
- Trial name
- BERENICE (NCT02132949)
- Testing
- 5-Fluorouracil, Cyclophosphamide, Docetaxel
- Where
- 80 sites in United States, Canada and 10 more
- Volunteers
- 401 people
- Sponsor
- Hoffmann-La Roche
Metastatic Breast Cancer
A Study of Abemaciclib (LY2835219) Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer
The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive (HR+), human epidermal growth factor receptor 2…
- Trial name
- Next MONARCH 1 (NCT02747004)
- Testing
- Abemaciclib, Tamoxifen, Prophylactic Loperamide
- Where
- 59 sites in United States, Argentina and 12 more
- Volunteers
- 234 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
Phase III Study of BKM120/Placebo With Fulvestrant in Postmenopausal Patients With Hormone Receptor Positive HER2-negative Locally Advanced or Metastatic Breast Cancer Refractory to Aromatase Inhibitor
This study was a multi-center, randomized, double-blind, placebo controlled Phase III study to determine the efficacy and safety of treatment with buparlisib plus fulvestrant versus fulvestrant plus placebo in postmenopausal…
- Trial name
- BELLE-2 (NCT01610284)
- Testing
- Fulvestrant, BKM120
- Where
- 268 sites in United States, Argentina and 27 more
- Volunteers
- 1,147 people
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy
This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with…
- Trial name
- SANDPIPER (NCT02340221)
- Testing
- Taselisib, Fulvestrant
- Where
- 157 sites in United States, Australia and 26 more
- Volunteers
- 631 people
- Sponsor
- Hoffmann-La Roche
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.
Breast Neoplasms, Triple Negative Breast Neoplasms
A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
Researchers are looking for new ways to treat types of breast cancer that are both: High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment Early-stage, which means the cancer is…
- Conditions
- Breast Neoplasms, Triple Negative Breast Neoplasms, HR Low-Positive/HER2-Negative Breast Neoplasms
- Trial name
- NCT06966700
- Testing
- Sacituzumab tirumotecan, Pembrolizumab, Rescue Medication
- Where
- 331 sites in United States, Argentina and 39 more
- Volunteers
- 2,400 people
- Sponsor
- Merck Sharp & Dohme LLC
Breast Neoplasms
A Study of Abemaciclib (LY2835219) Plus Hormone Therapy in Participants With Early Breast Cancer
The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery.
- Trial name
- eMonarcHER (NCT04752332)
- Testing
- Abemaciclib, Standard Adjuvant ET
- Where
- 115 sites in United States, Argentina and 18 more
- Volunteers
- 111 people
- Sponsor
- Eli Lilly and Company
Breast Cancer
Prospective Observational Study Evaluating Treatment Decision Impact of Prosigna® in Early Stage Breast Cancer Patients
This multicenter, prospectively designed study examines whether the Prosigna score influences physician and patient adjuvant treatment selection over and above currently used prognostic factors.
- Trial name
- NCT02625935
- Where
- 4 sites in United States
- Volunteers
- 206 people
- Sponsor
- NanoString Technologies, Inc.
Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer
Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer
The aim of this study is to identify the optimal dose for EP0062 as monotherapy and in combination with standard-of-care therapies to assess its Safety, Tolerability, Pharmacokinetics, and Efficacy in Patients with Relapsed…
- Conditions
- Hormone Receptor-positive Breast Cancer, Hormone Receptor Positive HER-2 Negative Breast Cancer, Metastatic Breast Cancer
- Trial name
- NCT05573126
- Testing
- EP0062, Elacestrant, Everolimus
- Where
- 14 sites in United States, Spain and 1 more
- Volunteers
- 95 people
- Sponsor
- Ellipses Pharma
Metastatic Breast Cancer
Pharmacokinetic Study of Pyrotinib and Docetaxel in Combination With Trastuzumab in Patients With HER2 Metastatic Breast Cancer
The primary objective of the study is to study the pharmacokinetics of pyrotinib and docetaxel plus Trastuzumab in HER2 Positive MBC.
- Trial name
- NCT04367090
- Testing
- Docetaxel, trastuzumab, Pyrotinib
- Where
- China
- Volunteers
- 97 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-6452 in Adult Patients With Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Advanced/Metastatic Breast Cancer or Locally Advanced/Metastatic Solid Tumor
This is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-6452 in adult patients with Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2…
- Conditions
- Breast Cancer (Locally Advanced or Metastatic), Advanced Solid Cancers, Metastatic (Stage IV) Breast Cancer, Ovarian Cancer
- Trial name
- NCT07612891
- Testing
- INV-6452
- Where
- China
- Volunteers
- 201 people
- Sponsor
- Shenzhen Ionova Life Sciences Co., Ltd.
Breast Cancer
Measuring the Impact of MammaPrint on Adjuvant and Neoadjuvant Treatment in Breast Cancer Patients: A Prospective Registry
The scope of this study is to measure the impact of MammaPrint on treatment in Hormone Receptor (HR)-positive HER2-negative breast cancer patients.
- Trial name
- IMPACt (NCT02670577)
- Where
- 17 sites in United States
- Volunteers
- 481 people
- Sponsor
- Agendia
ER-Positive, HER2-Negative Breast Cancer
A Phase 1 Study of HRS8807 Monotherapy and in Combination With SHR6390 in Subjects With ER-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer
The study is to assess safety and tolerability of HRS8807 monotherapy and in combination with SHR6390 in subjects with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum…
- Trial name
- NCT04993430
- Testing
- HRS8807, HRS8807、SHR6390
- Where
- China
- Volunteers
- 46 people
- Sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
Advanced/Metastatic HER2-positive Breast, Gastric, Gastroesophageal Junction Cancer With Disease Progression Following Anti-HER2 Standard of Care Treatment
A Study to Evaluate Safety, Tolerability, Dosimetry, and Preliminary Efficacy of the HER2 Directed Radioligand CAM-H2 in Patients With Advanced/Metastatic HER2-Positive Breast, Gastric, and Gastro-Esophageal Junction (GEJ) Cancer
This is a Phase 1/2 multi-center, open label, dose escalation and dose expansion study to evaluate safety, tolerability, dosimetry, pharmacodynamics (PD), and efficacy of the targeted radionuclide therapeutic CAM-H2 in patients…
- Trial name
- NCT04467515
- Testing
- CAM-H2
- Where
- 12 sites in United States, Canada
- Volunteers
- 13 people
- Sponsor
- Precirix
Metastatic Breast Cancer
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in…
- Trial name
- NCT01942135
- Testing
- Palbociclib, Fulvestrant
- Where
- 247 sites in United States, Australia and 15 more
- Volunteers
- 521 people
- Sponsor
- Pfizer
Breast Cancer
A Study to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel Versus Placebo + Trastuzumab + Docetaxel in Previously Untreated Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
This Phase III, randomized, double-blind, placebo-controlled, multicenter clinical trial in China will evaluate the efficacy and safety of pertuzumab + trastuzumab + docetaxel compared with placebo + trastuzumab + docetaxel in…
- Trial name
- PUFFIN (NCT02896855)
- Testing
- Docetaxel, Pertuzumab, Trastuzumab
- Where
- 15 sites in China
- Volunteers
- 243 people
- Sponsor
- Hoffmann-La Roche
ER+ HER2- Advanced Breast Cancer
AZD9496 First Time in Patients Ascending Dose Study
This is a phase 1 open label multicentre study of AZD9496 administered orally in patients with advanced ER+ HER2 negative breast cancer.
- Trial name
- NCT02248090
- Testing
- AZD9496
- Where
- 6 sites in United States, South Korea and 1 more
- Volunteers
- 45 people
- Sponsor
- AstraZeneca
Breast Cancer
Epidemiology and Treatment of HR+/HER2- Breast Cancer in England
The aim of this study was to describe the epidemiology, treatment pathway, treatment access, wastage of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i), and health care resource use among adults with hormone receptor positive…
- Trial name
- ROTOR (NCT07498413)
- Where
- United Kingdom
- Volunteers
- 218,677 people
- Sponsor
- Novartis Pharmaceuticals