A Phase 3 interventional study of Trastuzumab and Pertuzumab in HER2+ Breast Cancer, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 2 sites in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-06-23.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Phase 3, Interventional, and Treatment
This is an open, prospective and interventional clinical study. Patients with advanced Human Epidermal Growth Factor Receptor 2 (HER2) positive breast cancer resistant to trastuzumab will be enrolled in the study. Histological specimens obtained from different metastatic foci of patients, are used to conduct genome-wide sequencing together with Circulating tumor DNA (ctDNA) of blood samples. Meanwhile, investigator will construct PDO model based on biopsy tissue. Patients as well as their paired Patient-derived organoids (PDO) models are divided into six groups according to genomic signatures. Each group of patients will receive the best targeted treatment scheme from the current clinical perspective, while the matched PDO model will accept a variety of potential effective schemes intervention. The future treatment plan of patients will be timely adjusted based on the tumor inhibition rate of PDO models. This study is the first time to explore the best individualized application sequence of targeted therapy for refractory HER2 positive breast cancer by combining genome sequencing with drug sensitivity test of PDO model. The results are expected to improve the prognosis of patients with advanced HER2 positive breast cancer.
In previous studies, investigator found that dynamic genomics detection of metastatic foci can fully reveal the mechanism of trastuzumab resistance. Different anti-HER2 treatment strategies for different mechanisms can improve the efficacy of HER2 positive advanced breast cancer, and the PDO drug sensitivity test model of breast cancer can be prior to patients' response to the exact efficacy of specific regimens.This study aimed to explore the optimal individualized drug combination and order for patients with advanced HER2 positive breast cancer resistant to trastuzumab based on a variety of existing diagnosis and treatment methods. This is an open, prospective and interventional clinical study. Patients with advanced HER2 positive breast cancer resistant to trastuzumab will be enrolled in the study. Histological specimens obtained from different metastatic foci of patients, are used to conduct genome-wide sequencing together with ctDNA of blood samples. Meanwhile, investigator will construct PDO model based on biopsy tissue. Patients as well as their paired PDO models are divided into six groups according to genomic signatures. Each group of patients will receive the best targeted treatment scheme from the current clinical perspective, while the matched PDO model will accept a variety of potential effective schemes intervention. The future treatment plan of patients will be timely adjusted based on the tumor inhibition rate of PDO models. This study is the first time to explore the best individualized application sequence of targeted therapy for refractory HER2 positive breast cancer by combining genome sequencing with drug sensitivity test of PDO model. The results are expected to improve the prognosis of patients with advanced HER2 positive breast cancer.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 120 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Phenotype was signatured by HER2 low expression.
Drug: Trastuzumab · Drug: Pertuzumab · Drug: Nab paclitaxel
Signatured by wild type HER2 amplified.
Drug: Trastuzumab · Drug: Pertuzumab · Drug: Nab paclitaxel
Signatured by HER2 mutation.
Drug: Pyrotinib · Drug: Capecitabine
Signatured by HER2 downstream mutation of PI3KCA, TP53 or PTEN.
Drug: Trastuzumab · Drug: Nab paclitaxel · Drug: T-DM1 · Drug: Everolimus
Signatured by both ER and PR strongly expressed,or CCND1 amplified.
Drug: Trastuzumab · Drug: CDK4/6 inhibitor · Drug: AI
Signatured by high TMB or PD-L1 positively expressed.
Drug: Trastuzumab · Drug: Anti-PD-1 monoclonal antibody
Trastuzumab (6mg/Kg, iv.drip, d1, q3w)
Also known as: herceptin；Inetetamab
Patuzumab (420mg iv.drip, d1,q3w)
Also known as: Perjeta
nab-paclitaxel (200mg iv.drip, d1,d8, q3w)
Also known as: Abraxane
Pyroltinib (400mg po qd)
Also known as: SHR-1258
Capecitabine (1250mg/m2, po, bid, d1-d14, q3w).
T-DM1(3.6mg/Kg, iv.drip, d1, q3w)
Also known as: Trastuzumab Emtansine
Everolimus (4mg, po, qd)
Also known as: RAD001
Palbociclib (125mg, po, qd)
Also known as: Palbociclib；
Letrozole (2.5mg, qd).
Also known as: Letrozole
Cindilimab (200mg, iv.drip, d1, q3w)
Also known as: Sintilimab
ORR
objective response rate (ORR) according to RECIST (version 1.1) of each group
Time frame: Up to six weeks, first evaluation
PDO model inhibition rate
Tumor regression rate based on the calculation of the long diameter in each group
Time frame: during the procedure
PFS1
Progress free survival (PFS) according to RECIST (version 1.1) of each group
Time frame: during the procedure
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
First Affiliated Hospital Xi'an Jiaotong University