Clinical trials: HER2 Low Metastatic Breast Cancer
Breast Neoplasms, Breast Cancer
HER2 TREAT Study: Retrospective Study to Estimate the Prevalence of HER2-low in Unresectable and/or Metastatic Breast Cancer Patients Who Progress on Anti-Cancer Therapy Identified as HER2-Negative From Patient Medical Records in The Gulf Cooperation Council
HER2-low Breast cancer (BC) has emerged as a new subtype of BC with distinct clinical, pathological, and prognostic features. Little is known about the prevalence of the HER2-low subtype in HER2-negative patients, and previous…
- Conditions
- Breast Neoplasms, Breast Cancer, Breast Carcinoma, Genes
- Trial name
- NCT06125314
- Where
- 7 sites in Kuwait, Qatar and 2 more
- Volunteers
- 517 people
- Sponsor
- AstraZeneca
Breast Cancer Metastatic, HER2-positive Metastatic Breast Cancer
Dose-Expansion Modular Study To Explore the Safety, Tolerability, and Anti-tumor Activity of HER3- DXd Monotherapy and Combinations in Patients With Inoperable Advanced Breast Cancer (ABC) After Progression on T-DXd
ICARUS-BREAST02 is an open-label, multicenter, phase 1b/2, platform study that aims to evaluate the safety, tolerability, and efficacy of HER3-DXd monotherapy and in combination with other anti-cancer agents in patients with ABC.
- Conditions
- Breast Cancer Metastatic, HER2-positive Metastatic Breast Cancer, HER2 Low Breast Carcinoma, Advanced Breast Cancer
- Trial name
- ICARUSBREAST02 (NCT06298084)
- Testing
- Patritumab deruxtecan, Olaparib
- Where
- France
- Volunteers
- 152 people
- Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
Early Breast Cancer, Metastatic Breast Cancer
Real-World Data of Clinicopathological Characteristics and Management of Breast Cancer Patients According to HER2 Status
This is a data-driven, retrospective, longitudinal, population- based, observational, multi-centered study using secondary data captured from congruent electronic health records (EHRs).
- Conditions
- Early Breast Cancer, Metastatic Breast Cancer, Locally Advanced Breast Cancer
- Trial name
- RosHER (NCT05217381)
- Where
- 7 sites in Spain
- Volunteers
- 18,533 people
- Sponsor
- MedSIR
HER2-negative Breast Cancer, Metastatic Breast Cancer
Predicting Olaparib Sensitivity in Patients With Unresectable Locally Advanced/Metastatic HER2-negative Breast Cancer.
The primary objetive is to assess the capacity of the RAD51-foci score to predict the efficacy of olaparib in BRCA1/2, PALB2 or RAD51C/D mut advanced breast cancer (cohort 1).
- Conditions
- HER2-negative Breast Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer
- Trial name
- RADIOLA (NCT05340413)
- Testing
- Olaparib
- Where
- 5 sites in Spain
- Volunteers
- 65 people
- Sponsor
- SOLTI Breast Cancer Research Group
HER2 Low Advanced or Metastatic Breast Cancer
A Phase Ⅰb/Ⅱ Clinical Study of SHR-A1811 Combined With Other Therapies in Patients With HER2 Low Advanced or Metastatic Breast Cancer.
This study aims to evaluate the safety, tolerability, PK and preliminary anti-tumour activity of SHR-A1811 combined with other therapies in patients with HER2 low advanced or metastatic breast cancer.
- Trial name
- NCT05792410
- Testing
- SHR-A1811 & Dalpiciclib Isethionate Tablets, SHR-A1811 & Fulvestrant, SHR-A1811 & Bevacizumab injection
- Volunteers
- 300 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Metastatic Breast Cancer, ER-positive Breast Cancer
A Randomised Trial Comparing Trastuzumab Deruxtecan to CDK4/6 Inhibitors in Non-luminal A, ER-positive/HER2-low Metastatic Breast Cancer
The objective of this trial, DBCG R25, will be to evaluate the effect of trastuzumab-deruxtecan versus standard of care on progression-free survival (PFS) in first-line for patients with non-Luminal A, ER-positive/HER2-negative…
- Conditions
- Metastatic Breast Cancer, ER-positive Breast Cancer, Luminal B, Her2 Enriched
- Trial name
- DISCORDANT (NCT06585969)
- Testing
- Trastuzumab deruxtecan (T-DXd), Ribociclib with ET, Abemaciclib with ET
- Sponsor
- Danish Breast Cancer Cooperative Group
Breast Carcinoma
Study in Metastatic Breast Cancer Patients Receiving Eftilagimod Alpha or Placebo in Combination With Paclitaxel Chemotherapy
The goal of this clinical trial is to compare the safety and efficacy of eftilagimod alpha (efti) in combination with paclitaxel standard of care chemotherapy in participants with metastatic breast cancer.
- Trial name
- AIPAC-003 (NCT05747794)
- Testing
- eftilagimod alpha, Paclitaxel
- Where
- 22 sites in United States, Belgium and 3 more
- Volunteers
- 72 people
- Sponsor
- Immutep S.A.S.
Breast Cancer
A Study Comparing BL-M07D1 With DS-8201 in Patients With HR-Positive, HER2-Low Expressing Recurrent/Metastatic Breast Cancer
This trial is a randomized, open-label, multicenter Phase II study designed to evaluate the efficacy and safety of BL-M07D1 in patients with unresectable locally recurrent or metastatic HR-positive, HER2-low expressing breast…
- Trial name
- NCT07678957
- Testing
- BL-M07D1, DS-8201
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd.
Breast Cancer
SHR-A1811 in Combination With Adebrelimab for the Treatment of HER2 Low-expressing Metastatic Breast Cancer
To evaluate the efficacy and safety of the SHR-A1811 in combination with Adebrelimab regimen in HER2 low-expressing metastatic breast cancer
- Trial name
- NCT06411457
- Testing
- SHR-A1811+Adebrelimab
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Breast Cancer
HER2-low Unresectable and/or Metastatic Breast Cancer in Russia
Planned study population consists of approximately 3,150 adult patients with HER2-negative (IHC 0, + or IHC2+/ISH-) unresectable or metastatic BC enrolled to the study in order to obtain approximately 2,000 patients with…
- Trial name
- NCT05913440
- Where
- 40 sites in Russia
- Volunteers
- 1,669 people
- Sponsor
- AstraZeneca
Metastatic Breast Cancer
Low -Dose-bevacizumab and Pemetrexed Versus TPC in Metastatic HER2-negative Breast Cancer Patients
This is a single-center, open, randomized, controlled phase 2 clinical trial designed to compare low-dose-bevacizumab and pemetrexed with TPC in metastatic HER2-negative breast cancer patients after failure of taxanes and…
- Trial name
- NCT02829008
- Testing
- low-dose-bevacizumab/pemetrexed, Treatment of physician's choice
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Chinese Academy of Medical Sciences
Breast Cancer
Discontinuation of CDK4/6 Inhibitors in Patients With Metastatic HR Positive, HER2 Negative Breast Cancer
This is a low-intervention, randomized, non-comparative, open-label, multicenter, prospective, phase II trial investigating discontinuation of CDK4/6 inhibitors in patients with metastatic HR positive, HER2 negative breast cancer…
- Trial name
- NCT06207734
- Testing
- Continuation of CDK4/6 inhibitor Palbociclib, Discontinuation of CDK4/6 inhibitor Palbociclib, Continuation of CDK4/6 inhibitor -Palbociclib
- Where
- 13 sites in Germany
- Volunteers
- 120 people
- Sponsor
- Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
HER2-positive Breast Cancer, Metastatic Cancer
PRE-ISPY Phase I/II Oncology Platform Program
PRE-ISPY Phase I/II (I-SPY-P1) is an open-label, multisite platform study with multiple ongoing drug regimen arms added by protocol amendment which is designed to evaluate single agents or combinations in locally advanced…
- Conditions
- HER2-positive Breast Cancer, Metastatic Cancer, Metastatic Breast Cancer, Metastatic
- Trial name
- PRE-ISPY (NCT05868226)
- Testing
- ALX148, Fam-Trastuzumab Deruxtecan-Nxki, Zanidatamab
- Where
- 10 sites in United States
- Volunteers
- 280 people
- Sponsor
- QuantumLeap Healthcare Collaborative
Breast Cancer, HER2-low Breast Cancer
TReatment of ADC-Refractory Breast CancEr With Dato-DXd or T-DXd: TRADE DXd
The purpose of this study is to test the safety and effectiveness of the sequence of two investigational drugs (trastuzumab deruxtecan followed by datopotamab deruxtecan, or datopotamab deruxtecan followed by trastuzumab…
- Conditions
- Breast Cancer, HER2-low Breast Cancer, Metastatic Breast Cancer, HER2-negative Breast Cancer
- Trial name
- TRADE DXd (NCT06533826)
- Testing
- Trastuzumab Deruxtecan, Datopotamab Deruxtecan
- Where
- 11 sites in United States
- Volunteers
- 357 people
- Sponsor
- Ana C Garrido-Castro, MD
Breast Cancer Stage IV, HER2-low Breast Cancer
HER2-PET as a Precision Imaging Tool for Treatment With HER2-ADC in HER2-expressing mBC
This is a prospective, multi-center, open-label, exploratory diagnostic phase II imaging trial for patients with metastatic breast cancer with at least one line of systemic therapy.
- Conditions
- Breast Cancer Stage IV, HER2-low Breast Cancer, Molecular Imaging
- Trial name
- NCT06830382
- Testing
- Positron emission tomografy with [68Ga]Ga-ABY-025
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Renske Altena
Hormone Receptor Positive, HER2-low or HER2-ultralow
A Study of Patritumab Deruxtecan (HER3-DXd) in Combination With Trastuzumab Deruxtecan (T-DXd) in Participants With HR-Positive, HER2-Low or HER2-Ultralow Unresectable or Metastatic Breast Cancer
The primary purpose of the study is to assess the safety, tolerability, and anti-tumor activity of HER3-DXd and T-DXd in the combination dosing regimens in participants with hormone receptor positive, HER2-low or HER2-ultralow…
- Conditions
- Hormone Receptor Positive, HER2-low or HER2-ultralow, Unresectable or Metastatic Breast Cancer
- Trial name
- NCT07701941
- Testing
- Patritumab deruxtecan, Trastuzumab deruxtecan
- Where
- 72 sites in United States, Belgium and 6 more
- Volunteers
- 220 people
- Sponsor
- Daiichi Sankyo
Breast Cancer Metastatic
A Phase II Study of SHR-A1811 Combined With Radiotherapy in HER2-positive and HER2-low Breast Cancer Brain Metastases
A prospective, single-arm study to explore the efficacy and safety of SHR-A1811 combined with radiotherapy in patients with HER2-positive or HER2-low brain metastases
- Trial name
- NCT06975462
- Testing
- SHR-A1811 and radiotherapy
- Volunteers
- 30 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8
Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial
This phase II ComboMATCH treatment trial studies the effect of adding a drug called BYL719 (alpelisib) to the usual treatment of olaparib in patients with breast cancer that has spread from where it first started (breast) to…
- Conditions
- Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Metastatic HER2-Negative Breast Carcinoma, Unresectable HER2-Negative Breast Carcinoma
- Trial name
- NCT05967286
- Testing
- Alpelisib, Biopsy, Biospecimen Collection
- Sponsor
- National Cancer Institute (NCI)
Metastatic Breast Cancer, HER2 Low Breast Carcinoma
ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer
The goal of this study is to evaluate the safety and efficacy of elacestrant in combination with trastuzumab deruxtecan (T-DXd) in participants with hormone receptor-positive (HR+), HER2-low or HER2-ultralow, metastatic breast…
- Conditions
- Metastatic Breast Cancer, HER2 Low Breast Carcinoma, HER2-negative Breast Cancer, Breast Cancer
- Trial name
- ERADICATE (NCT07198724)
- Testing
- Elacestrant, Trastuzumab Deruxtecan
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Kristina A. Fanucci
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)