Clinical trials: Her2 Positive Metastatic Breast Cancer
Metastatic HER2+ Advanced Breast Cancer
Real World-clinical Outcomes of Tucatinib, Trastuzumab, and Capecitabine Following Trastuzumab Deruxtecan (T-DXd) for the Treatment of HER2-positive Metastatic Breast Cancer.
A retrospective study of de-identified (to preserve patient privacy) patient information from the Flatiron Health Database to describe 3L and 4L real-world (rw) outcomes (e.g.
- Trial name
- NCT06961331
- Testing
- Tucatinib, Trastuzumab, Capecitabine
- Where
- United States
- Volunteers
- 86 people
- Sponsor
- Pfizer
Breast Cancer
A European Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced (LA) or Metastatic Breast Cancer (mBC) (SAMANTHA)
This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable LA/mBC.
- Trial name
- NCT02913456
- Where
- 54 sites in Austria, Bulgaria and 3 more
- Volunteers
- 629 people
- Sponsor
- Hoffmann-La Roche
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.
Breast Carcinoma Metastatic in Lymph Node, HER2 Positive Breast Carcinoma
Validation of TAD in HER-2 with More Than 2 Lymph Nodes
The main objective of the study is to validate the DAT technique in patients with Her2-positive breast cancer who have more than two positive axillary lymph nodes at diagnosis.
- Trial name
- DAD-HER2 (NCT06821490)
- Testing
- Targeted axillary dissection and subsequently a lymphadenectomy
- Where
- Spain
- Volunteers
- 21 people
- Sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
HER2-positive Metastatic Breast Cancer, Stage IV Breast Cancer
Discontinuation of Maintenance HER-2 Directed Therapy in Long-Term Survivors of Metastatic HER-2 Positive Breast Cancer
The purpose of this preliminary research study is to see if patients discontinuing maintenance Herceptin and/or other anti-HER-2 treatments with monitoring in addition to radiologic imaging and routine blood work will stay in…
- Trial name
- Free-HER (NCT05959291)
- Testing
- Discontinuation of Anti-HER-2 Maintenance Treatment
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Miami
Breast Cancer
A Phase III Study of Bevacizumab and Paclitaxel in Combination With Atezolizumab as a Treatment for Locally Advanced Unresectable or Metastatic Hormone Receptor-positive HER2 Negative Breast Cancer
JCOG1919E (AMBITION) is a randomized, open-label, phase 3 trial to evaluate efficacy and safety of bevacizumab and paclitaxel in combination with atezolizumab comparing to bevacizumab and paclitaxel in patients with HR-positive…
- Trial name
- AMBITION (NCT04732598)
- Testing
- Paclitaxel + bevacizumab therapy, Paclitaxel + bevacizumab + atezolizumab
- Where
- Japan
- Volunteers
- 281 people
- Sponsor
- Japanese Foundation for Cancer Research
Breast Cancer
Efficacy and Safety of Inetetamab Plus Pyrotiniband and Capecitabine in HER2-positive Metastatic Breast Cancer Patients With or Without Brain Metastasis
This study intends to include HER2-positive metastatic breast cancer patients (with or without brain metastasis) who have become resistant to previous treatment with trastuzumab.
- Trial name
- NCT06015100
- Testing
- Inetetamab plus pyrotiniband and capecitabine
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Yan Xue
HER2-positive Breast Cancer, Male Breast Cancer
Vaccine Therapy in Treating Patients Receiving Trastuzumab For HER2-Positive Stage IIIB-IV Breast Cancer
This phase II trial is studying how well vaccine therapy works in treating patients receiving trastuzumab for HER2-positive stage IIIB- IV breast cancer.
- Conditions
- HER2-positive Breast Cancer, Male Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
- Trial name
- NCT00343109
- Testing
- HER-2/neu intracellular domain protein, leukapheresis, laboratory biomarker analysis
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- University of Washington
Metastatic Breast Cancer
A Study of Trastuzumab-Mcc-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer
Study of trastuzumab emtansine (T-DM1) administered to patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.
- Trial name
- NCT00679211
- Testing
- Trastuzumab emtansine [Kadcyla]
- Volunteers
- 110 people
- Sponsor
- Genentech, Inc.
Breast Cancer
Artificial Intelligence and Machine Learning to Guide CDK4/6 Inhibitor Rechallenge in Breast Cancer.
The goal of this clinical trial is to learn if an artificial intelligence model will be able to select patients with advanced breast cancer who may respond to a second cyclin-dependent kinase 4/6 (CDK4/6) inhibitor after they…
- Trial name
- AIM-BRIGHT (NCT07227233)
- Testing
- A CDK4/6 inhibitor different from the first that the participant had received, plus fulvestrant., Treatment of physician's choice
- Where
- United States
- Volunteers
- 105 people
- Sponsor
- University of California, San Diego
Breast Cancer
MEtronomic TrEatment Option in Advanced bReast cAncer
This is a multi-center, randomized phase II trial that will randomise women with ER-positive, HER2-negative (Human Epidermal Growth factor Receptor 2-negative) metastatic or locally relapsed breast cancer in a ratio of 1:1 to…
- Trial name
- METEORA-II (NCT02954055)
- Testing
- Paclitaxel, Cyclophosphamide, Capecitabine
- Where
- 20 sites in Italy
- Volunteers
- 140 people
- Sponsor
- ETOP IBCSG Partners Foundation
Advanced Malignant Solid Neoplasm, Estrogen Receptor Positive
Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients
This phase I trial studies the side effects and best dose of everolimus and trastuzumab when given together with letrozole in treating patients with hormone receptor-positive and human epidermal growth factor (EGF) receptor 2…
- Conditions
- Advanced Malignant Solid Neoplasm, Estrogen Receptor Positive, HER2/Neu Positive, Postmenopausal
- Trial name
- NCT02152943
- Testing
- Everolimus, Laboratory Biomarker Analysis, Letrozole
- Where
- 5 sites in United States
- Volunteers
- 37 people
- Sponsor
- M.D. Anderson Cancer Center
Metastatic Breast Cancer, HER2 + Breast Cancer
A First-in-Human Phase 1 Safety and Biodistribution of [177Lu]Lu-ABY-271 in Subjects With HER2-positive Metastatic Breast Cancer
This is a FiH phase 1, open-label, two-stage, randomized trial to assess the safety, tolerability, and biodistribution of [177Lu]Lu-ABY-271 in subjects with HER2 positive metastatic breast cancer.
- Trial name
- NCT07081555
- Testing
- [177Lu]Lu-ABY-271
- Where
- 3 sites in Sweden
- Volunteers
- 21 people
- Sponsor
- Affibody
Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive
Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis
This phase II trial studies how well radiation therapy given with standard care palbociclib and hormone therapy work in treating patients with breast cancer that has spread from one part of the body to the bone.
- Conditions
- Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive, HER2/Neu Negative, Metastatic Breast Carcinoma
- Trial name
- ASPIRE (NCT03691493)
- Testing
- Anastrozole, Exemestane, Fulvestrant
- Where
- 10 sites in United States
- Volunteers
- 36 people
- Sponsor
- Emory University
Breast Cancer
A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
The main purpose of this study is to evaluate how effective nonsteroidal aromatase inhibitors (NSAI) plus abemaciclib are in postmenopausal women with breast cancer.
- Trial name
- MONARCH 3 (NCT02246621)
- Testing
- Abemaciclib, Anastrozole, Letrozole
- Where
- 155 sites in United States, Australia and 20 more
- Volunteers
- 493 people
- Sponsor
- Eli Lilly and Company
HER2 Positive Metastatic Breast Cancers
A Study of Tucatinib (ONT-380) Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer
The purpose of this study is to determine the maximal tolerated dose (MTD) or recommended phase 2 dose (RP2D) of tucatinib (ONT-380) and to assess the safety and tolerability of tucatinib (ONT-380) combined with capecitabine…
- Trial name
- NCT02025192
- Testing
- Tucatinib, Capecitabine, Trastuzumab
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- Seagen Inc.
Breast Cancer
Tucatinib, Palbociclib and Letrozole in Metastatic Hormone Receptor Positive and HER2-positive Breast Cancer
This is a multicenter run-in phase Ib / roll-over phase II study of triple targeted drug combination (HER2-targeted small molecule inhibitor tucatinib, CDK4/6 inhibitor palbociclib and aromatase inhibitor letrozole) as a first or…
- Trial name
- NCT03054363
- Testing
- Tucatinib in Combination with Palbociclib and Letrozole
- Where
- 6 sites in United States
- Volunteers
- 42 people
- Sponsor
- University of Colorado, Denver
Advanced Breast Cancer, Advanced or Metastatic Breast Cancer
A Study to Learn About the Study Medicine Called PF-08165784 in People With PIK3CA-Mutated Advanced or Metastatic Solid Tumors
The purpose of this study is to learn about the safety and effects of the study medicine (called PF-08165784) when given alone or together with other anti-cancer therapies.
- Conditions
- Advanced Breast Cancer, Advanced or Metastatic Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Metastatic Colorectal Adenocarcinoma
- Trial name
- NCT07897721
- Testing
- PF-08165784, Fulvestrant, Atirmociclib
- Volunteers
- 268 people
- Sponsor
- Pfizer
Breast Cancer, Metastatic Breast Cancer
Vinorelbine With Trastuzumab Emtansine in Pre-Treated HER2-Positive Metastatic Breast Cancer
The study proposes to evaluate the safety and efficacy of the combination of trastuzumab emtansine (T-DM1) and vinorelbine in HER2+ metastatic breast cancer patients.
- Trial name
- NCT02658084
- Testing
- Vinorelbine, Trastuzumab Emtansine
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of Miami
ER+, HER2-, Metastatic Breast Cancer
AZD9833 China PK Study
A Phase 1 Dose Escalation and Expansion Study of AZD9833 Alone or in Combination in Chinese patients with ER Positive, HER2 Negative, Metastatic Breast Cancer
- Trial name
- AZD9833 (NCT04818632)
- Testing
- AZD9833, AZD9833 with palbociclib, AZD9833 with everolimus
- Where
- 4 sites in China
- Volunteers
- 28 people
- Sponsor
- AstraZeneca