Clinical trials: Her2 Positive Metastatic Breast Cancer
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
HER2 Positive Metastatic Breast Cancer
Pyrotinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer. (PHOEBE)
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER-1 and HER-2 receptors. This study is a randomized,open-label,multi-center,active-controlled, parallel design study of the combination of pyrotinib and capecitabine…
- Trial name
- NCT03080805
- Testing
- Pyrotinib Plus Capecitabine, Lapatinib Plus Capecitabine
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer
Efficacy and Safety of KN026 in Combination With HB1801 in the First-line Treatment of Subjects With HER2-positive Recurrent or Metastatic Breast Cancer.
This is a randomized, controlled, open-label, multicenter, phase Ш clinical study designed to compare the efficacy and safety of KN026 in combination with HB1801 to trastuzumab in combination with pertuzumab and docetaxel in the…
- Trial name
- NCT05838066
- Testing
- Recombinant Humanized Bispecific antibody against HER2，KN026, HB1801, Pertuzumab
- Where
- China
- Volunteers
- 880 people
- Sponsor
- Shanghai JMT-Bio Inc.
Metastatic Breast Adenocarcinoma, Breast Cancer
CR1447 in Endocrine Responsive-HER2neg and TN-ARpos Breast Cancer
SAKK 21/12 is a stratified, multicenter Phase II first in-human trial with transdermal CR1447 (4-OH-testosterone) and is directed to patients with endocrine responsive-HER2neg and TN-ARpos metastatic or locally advanced breast…
- Trial name
- NCT02067741
- Testing
- CR1447
- Where
- 13 sites in Switzerland
- Volunteers
- 29 people
- Sponsor
- Swiss Cancer Institute
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
ER-positive and HER2-negative Metastatic or Locally Advanced Breast Cancer, a Germline or Somatic BRCA Mutation, or a Deleterious Alteration of Other Genes Involved in Homologous Recombination Repair (HRR) or in MSI Status
Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients.
This study evaluates the efficacy of the combination of olaparib, durvalumab, and fulvestrant for the treatment of patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer with BRCA gene alterations…
- Trial name
- DOLAF (NCT04053322)
- Testing
- Durvalumab, Olaparib, Fulvestrant
- Where
- 2 sites in France
- Volunteers
- 172 people
- Sponsor
- UNICANCER
HER2-positive Breast Cancer
Tucatinib in Combination With Oral Etoposide andTrastuzumab in Patients With Metastatic HER2+ Breast Cancer
This is an open-label, multicenter, phase II study to evaluate the efficacy, safety, tolerability, pharmacokinetics of the combination of tucatinib-Oral VP16-trastuzumab in patients with HER2-positive metastatic breast cancer…
- Trial name
- TUC-TOC (NCT05955170)
- Testing
- Tucatinib in Combination of Oral VP16 and trastuzumab
- Where
- 13 sites in France
- Volunteers
- 66 people
- Sponsor
- Institut Curie
Metastatic Breast Cancer
Detect V / CHEVENDO (Chemo vs. Endo)
Chemo- versus endocrine therapy in combination with dual HER2-targeted therapy of Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus Kisqali® (ribociclib) in patients with HER2 positive and hormone-receptor positive…
- Trial name
- NCT02344472
- Testing
- pertuzumab, Trastuzumab, Capecitabine
- Where
- Germany
- Volunteers
- 271 people
- Sponsor
- Prof. Wolfgang Janni
Breast Cancer
Initial CDK 4/6 Inhibitor Plus Endocrine Therapy Versus Initial Chemotherapy in HR Positive, HER2 Negative Unresectable or Metastatic Breast Cancer
A multi-center, real world study to evaluate the clinical outcomes between initial CDK 4/6 Inhibitor plus endocrine therapy and initial chemotherapy in HR positive, HER2 negative unresectable or metastatic breast cancer.
- Trial name
- NCT06344793
- Where
- China
- Volunteers
- 608 people
- Sponsor
- Fudan University
Breast Cancer
Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer
This is a phase l/II study. The purpose of this study is to test the safety of the study drug neratinib in combination with a standard chemotherapy drug called capecitabine at different doses to find out what effects, if any, it…
- Trial name
- NCT03377387
- Testing
- Capecitabine, Neratinib, EORTC QLQ - BR23, EQ-5D-5L, EORTC QLQ-C30
- Where
- 10 sites in United States
- Volunteers
- 34 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
HER2 Positive Metastatic Breast Cancer
A Study to Evaluate the Pharmacokinetics of Margetuximab in Chinese Patients With HER2+ MBC
This is an open-label, Single-arm, Phase I clinical study to evaluate the pharmacokinetics, tolerability and safety of margetuximab plus chemotherapy in Chinese patients with advanced HER2+ breast cancer who have received…
- Trial name
- NCT04398108
- Testing
- Margetuximab Margetuximab-IV
- Where
- 3 sites in China
- Volunteers
- 16 people
- Sponsor
- Zai Lab (Shanghai) Co., Ltd.
Locally Advance Breast Cancer (LABC), Metastatic Breast Cancer (MBC)
A Phase Ib/II Study of BEZ235 and Trastuzumab in Patients With HER2-positive Breast Cancer Who Failed Prior to Trastuzumab
This is a prospective, multi-center, open-label, phase Ib/ II study (two parts) with patients that have locally advanced or metastatic HER2+ breast cancer.
- Trial name
- NCT01471847
- Testing
- BEZ235 + Trastuzumab Phase l/Phase ll), Lapatinib + Capecitabine (Phase II)
- Where
- 3 sites in Spain, United Kingdom
- Volunteers
- 5 people
- Sponsor
- Novartis Pharmaceuticals
Metastatic Breast Cancer, HER2-negative Breast Cancer
Alpelisib, Fulvestrant and Dapagliflozin for the Treatment of HR+, HER2 -, PIK3CA Mutant Metastatic Breast Cancer
This will be a single arm, open label pilot to test the combination of dapagliflozin, a commercially available SGLT-2 inhibitor, in combination with alpelisib + fulvestrant in patients with HR+/HER2- mBC.
- Trial name
- NCT05025735
- Testing
- Dapagliflozin 10Mg Tab
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Saint Luke's Health System
PIK3CA Mutation, Solid Tumor, Adult
First-in-Human Study of RLY-5836 in Advanced Breast Cancer and Other Solid Tumors
This is a Phase 1, first-in-human, open-label study designed to evaluate the maximum tolerated dose (MTD), recommended phase 2 dose (RP2D), safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor…
- Conditions
- PIK3CA Mutation, Solid Tumor, Adult, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- NCT05759949
- Testing
- RLY-5836, Fulvestrant, Palbociclib
- Where
- 7 sites in United States
- Volunteers
- 41 people
- Sponsor
- Relay Therapeutics, Inc.
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Testing the Safety of the Combination of Anti-Cancer Drugs CX-5461 (Pidnarulex) and Trastuzumab Deruxtecan (T-DXd) for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Solid Tumors and Breast Cancer
This phase I trial tests the safety, side effects, and best dose of pidnarulex in combination with trastuzumab deruxtecan in treating patients with breast cancer and other solid tumors that express varying levels of a protein…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Invasive Breast Carcinoma, Locally Advanced Breast Carcinoma
- Trial name
- NCT07137416
- Testing
- Biopsy Procedure, Biospecimen Collection, Echocardiography Test
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- National Cancer Institute (NCI)
HER2 Positive Metastatic Breast Cancer
ARX788 in HER2-positive, Metastatic Breast Cancer Subjects (ACE-Breast-03)
A Global, Phase 2 Study of ARX788 in HER2-positive Metastatic Breast Cancer Patients who were previously treated with T-DXd
- Trial name
- NCT04829604
- Testing
- ARX788
- Where
- 33 sites in United States, Australia and 1 more
- Volunteers
- 72 people
- Sponsor
- Ambrx, Inc.
Locally Advanced or Metastatic Breast Cancer
Phase II/III Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer
This study is designed to evaluate the safety and efficacy of SPH4336 combined with letrozole in first-line treatment of locally advanced or metastatic breast cancer
- Trial name
- NCT05744687
- Testing
- SPH4336 Tablets 400mg
- Where
- 9 sites in China
- Volunteers
- 374 people
- Sponsor
- Shanghai Pharmaceuticals Holding Co., Ltd
HER2-positive Locally Advanced or Metastatic Breast Cancer
A Phase III Trial of Pertuzumab Retreatment in Previously Pertuzumab Treated Her2-Positive Advanced Breast Cancer
The purpose of this study is to evaluate the efficacy and safety of pertuzumab, trastuzumab and chemotherapy as a pertuzumab retreatment compared to trastuzumab and chemotherapy in locally advanced or metastatic breast cancer…
- Trial name
- PRECIOUS (NCT02514681)
- Testing
- Trastuzumab, Pertuzumab, Docetaxel
- Where
- 3 sites in Japan
- Volunteers
- 226 people
- Sponsor
- Japan Breast Cancer Research Group
Metastatic Breast Cancer, HER2-negative Breast Cancer
Trial of 225Ac-DOTATATE (RYZ101) in Subjects With ER+, HER2-negative Unresectable or Metastatic Breast Cancer Expressing SSTRs.
Phase 1b/2 open-label trial of 225Ac-DOTATATE (RYZ101) in subjects with ER+, HER2-negative unresectable or metastatic breast cancer expressing SSTRs.
- Conditions
- Metastatic Breast Cancer, HER2-negative Breast Cancer, ER+ Breast Cancer, Advanced Breast Cancer
- Trial name
- TRACY-1 (NCT06590857)
- Testing
- RYZ101, Standard of Care Endocrine Therapy
- Where
- 31 sites in United States, Canada and 1 more
- Volunteers
- 64 people
- Sponsor
- RayzeBio, Inc.
HER2-positive Breast Cancer
A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer
This study is a registered phase III, randomized, open-label, multicenter study to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally advanced or metastatic HER2-positive breast cancer who had…
- Trial name
- NCT06316531
- Testing
- BL-M07D1, T-DM1
- Where
- China
- Volunteers
- 274 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.