Clinical trials: Her2 Positive Metastatic Breast Cancer
Breast Cancer
Targeting EGFR/ERBB2 With Neratinib in Hormone Receptor (HR)-Positive/HER2-negative HER2-enriched Advanced/Metastatic Breast Cancer
HR+/HER2-negative BC represent ∼70% of all newly diagnosed breast tumours and are responsible for most recurrences and deaths due to this disease, and despite available standard therapies, ∼15-20% of hormone tumours recur at…
- Trial name
- NEREA (NCT04460430)
- Testing
- Neratinib + endocrine therapy
- Where
- 15 sites in Portugal, Spain
- Volunteers
- 12 people
- Sponsor
- SOLTI Breast Cancer Research Group
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
HR-positive, HER2-negative Metastatic Breast Cancer With Brain Metastases
Culmerciclib Plus Anlotinib and Endocrine Therapy for HR-Positive/HER2-Negative Metastatic Breast Cancer With Brain Metastases
This study aims to evaluate the efficacy and safety of adding the anti-angiogenic agent anlotinib to the combination of the CDK2/4/6 inhibitor Culmerciclib and endocrine therapy in patients with HR+/HER2- breast cancer and brain…
- Trial name
- NCT07745257
- Testing
- Culmerciclib, Anlotinib, Endocrine Therapy
- Where
- 9 sites in China
- Volunteers
- 40 people
- Sponsor
- Sun Yat-sen University
Breast Neoplasms
The XENERA™ 1 Study Tests Xentuzumab in Combination With Everolimus and Exemestane in Women With Hormone Receptor Positive and HER2-negative Breast Cancer That Has Spread
The main objective of the trial is to assess the efficacy of xentuzumab in combination with everolimus and exemestane over everolimus and exemestane in patients with HR+/ HER2- advanced or metastatic breast cancer and…
- Trial name
- NCT03659136
- Testing
- Xentuzumab, Everolimus, Exemestane
- Where
- 54 sites in United States, Australia and 9 more
- Volunteers
- 103 people
- Sponsor
- Boehringer Ingelheim
Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma
Tka Assay for CDK4/6i
This clinical trial assesses whether using a test developed by DiviTum can identify optimal levels of CDK 4/6 inhibitor medications in the blood and whether assessing medical compliance and drug-drug interactions can optimize…
- Trial name
- NCT06572800
- Testing
- DiviTum-TKa
- Where
- 18 sites in United States
- Volunteers
- 34 people
- Sponsor
- Yale University
Breast Cancer, Breast Cancer - Female
TEEL Study- Phase 1 Tamoxifen and Ribociclib (LEE011) in Advanced ER+ (HER2 Negative) Breast Cancer
The purpose of this study is to find out if the investigational drug Ribociclib (LEE011), when taken with standard treatment (Tamoxifen +/- Goserelin) is safe and has beneficial effects in pre-menopausal and post-menopausal women…
- Conditions
- Breast Cancer, Breast Cancer - Female, Breast Cancer - Male
- Trial name
- NCT02586675
- Testing
- Tamoxifen, Ribociclib, Goserelin
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
Breast Cancer
HER2-positive Breast Cancer Project Initiated by Investigators
This study will assess the objective response rate (ORR), safety, progression-free survival (PFS) , overall survival (OS), 6-month survival rate, 12-month survival rate, 18-month survival rate, 24-month survival rate, disease…
- Trial name
- NCT05346328
- Testing
- Injection of A166
- Volunteers
- 48 people
- Sponsor
- Fudan University
Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer, Metastatic Cervical Cancer
HER-Seq: A Blood-based Screening Study to Identify Patients With HER2 Mutations for Enrollment Into Clinical Research Studies of Neratinib
This is a multi-center, observational genomic screening protocol to identify participants whose tumors harbor somatic mutations in the ERBB2 (HER2) gene, as measured in circulating tumor DNA (ctDNA) .
- Trial name
- NCT03786107
- Testing
- Almac HER-Seq Assay
- Where
- 22 sites in United States, France and 5 more
- Volunteers
- 1,583 people
- Sponsor
- Puma Biotechnology, Inc.
Advanced or Metastatic Breast Cancer
A Study of AND019 in Women With ER Positive HER2 Negative Advanced or Metastatic Breast Cancer
This is a first in human dose escalation and expansion study to evaluate the safety, tolerability, pharmacokinetic (PK), pharmacodynamic (PD) activity, and preliminary anti-tumor activity of AND019 in postmenopausal women with…
- Trial name
- NCT05187832
- Testing
- AND019 PO QD
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Kind Pharmaceuticals LLC
Breast Cancer
A Study of AC682 In Chinese Patients With ER+/HER2- Locally Advanced or Metastatic Breast Cancer
This clinical trial is evaluating AC682 in participants with estrogen receptor positive/human epidermal growth factor 2 negative (ER+/HER2-) locally advanced or metastatic breast cancer. The main goals of this study are to: 1.
- Trial name
- NCT05489679
- Testing
- AC682
- Where
- 3 sites in China
- Volunteers
- 6 people
- Sponsor
- Accutar Biotechnology Inc
Metastatic Breast Cancer
Palbociclib in Molecularly Characterized ER-positive/HER2-negative Metastatic Breast Cancer
This international, multicenter, prospective single arm Phase II biomarker discovery clinical trial with the primary objective of assessing the association of PFS with gene mutations, gene copy number aberrations and gene…
- Trial name
- PYTHIA (NCT02536742)
- Testing
- Palbociclib, Fulvestrant
- Where
- 19 sites in Belgium, Italy and 1 more
- Volunteers
- 124 people
- Sponsor
- ETOP IBCSG Partners Foundation
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Abexinostat, Palbociclib, and Fulvestrant for the Treatment of Breast or Gynecologic Cancer
This phase I trial investigates the side effects and best dose of abexinostat and palbociclib when given together with fulvestrant in treating patients with breast or gynecologic cancer.
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8
- Trial name
- NCT04498520
- Testing
- Abexinostat Tosylate, Fulvestrant, Palbociclib
- Sponsor
- Pamela Munster
Metastatic Breast Cancer
HER2-positive Metastatic Breast Cancer in Kazakhstan
Planned study population consists of approximately 240 adult patients with HER2-positive mBC receiving anti-HER2 therapy in 12 oncological centers (in each center it is expected to recruit about 20 patients) in different regions…
- Trial name
- NCT07593196
- Where
- 12 sites in Kazakhstan
- Volunteers
- 240 people
- Sponsor
- AstraZeneca
Metastatic Breast Cancer
Corrected QT Interval Effects of Trastuzumab Emtansine (T-DM1) in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer and the Safety and Tolerability of Combined T-DM1 and Pertuzumab in Patients With Early Disease Progression
This is a multicenter, open-label, single-arm Phase II study designed to evaluate the effect of T-DM1 on the duration of corrected QT (QTc) interval in patients with HER2-positive locally advanced or metastatic breast cancer and…
- Trial name
- NCT00943670
- Testing
- pertuzumab, Trastuzumab emtansine [Kadcyla]
- Volunteers
- 51 people
- Sponsor
- Genentech, Inc.
Breast Neoplasms, Cancer of the Breast
A Trial for HER2 Positive Breast Cancer Patients With Metastatic Disease
This phase II trial that includes Gemcitabine 1,250mg/m2 to be administered over approximately 30 minutes on days 1 and 8, every 21 days and Trastuzumab 8 mg/kg IV to be administered over 90 minutes on day 1 of the first cycle…
- Conditions
- Breast Neoplasms, Cancer of the Breast, Breast Cancer
- Trial name
- NCT00191373
- Testing
- Gemcitabine, Trastuzumab
- Where
- 13 sites in United States
- Volunteers
- 66 people
- Sponsor
- Eli Lilly and Company
Metastatic Breast Cancer
Durvalumab in Patients With HER-2 Positive Metastatic Breast Cancer Receiving Trastuzumab
The purpose of this study is to find the highest dose of durvalumab that can be tolerated without causing very severe side effects when receiving standard treatment and to see what effects the study drug has on this type of…
- Trial name
- NCT02649686
- Testing
- Durvalumab, Trastuzumab
- Where
- 3 sites in Canada
- Volunteers
- 15 people
- Sponsor
- Canadian Cancer Trials Group
Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma
A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors
This clinical trial is studying solid tumor cancers. A solid tumor is one that starts in part of your body like your lungs or liver instead of your blood.
- Conditions
- Breast Neoplasms, Gastroesophageal Junction Adenocarcinoma, HER2 Low Breast Neoplasms, HER2 Positive Breast Neoplasms
- Trial name
- NCT06157892
- Testing
- disitamab vedotin, tucatinib
- Where
- 135 sites in United States, Australia and 8 more
- Volunteers
- 54 people
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
Metastatic Breast Cancer, Locally Advanced Breast Cancer
Impact of Endocrine Therapy and Abemaciclib on Host and Tumor Immune Cell Repertoire/Function in Advanced ER+/HER2- Breast Cancer
The purpose of this study is to perform an in depth analysis of changes in the tumor immune microenvironment in patients undergoing treatment with standard of care endocrine therapy and abemaciclib in the advanced setting via…
- Conditions
- Metastatic Breast Cancer, Locally Advanced Breast Cancer, Hormone Receptor Positive Tumor
- Trial name
- NCT04352777
- Testing
- Abemaciclib, Fulvestrant, Aromatase Inhibitors
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Duke University
Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer
Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer
Trial design: Phase II, prospective, multi-center, randomized, open label, parallel group study in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer with gBRCA1/2 mutation, with 2:1…
- Conditions
- Hormone Receptor Positive HER-2 Negative Breast Cancer, Advanced or Metastatic Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- Trial name
- ELEMENT (NCT06201234)
- Testing
- Olaparib + Elacestrant, Olaparib
- Where
- 36 sites in Germany
- Volunteers
- 176 people
- Sponsor
- GBG Forschungs GmbH
Breast Cancer, Advanced Breast Cancer
OP-1250 (Palazestrant) vs. Standard of Care for the Treatment of ER+/HER2- Advanced Breast Cancer
This phase 3 clinical trial compares the safety and efficacy of palazestrant (OP-1250) to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one…
- Conditions
- Breast Cancer, Advanced Breast Cancer, Metastatic Breast Cancer, ER Positive Breast Cancer
- Trial name
- OPERA-01 (NCT06016738)
- Testing
- Palazestrant, Fulvestrant, Anastrozole
- Where
- 233 sites in United States, Argentina and 24 more
- Volunteers
- 510 people
- Sponsor
- Olema Pharmaceuticals, Inc.