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Trastuzumab(Henlius®) Combined With Pertuzumab(Perjeta®) and Chemotherapy in Chinese Patients With Her2-Positive Metastatic Breast Cancer Previously Treated With Trastuzumab | Clinical Trials | Clareo Health

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Trastuzumab(Henlius®) Combined With Pertuzumab(Perjeta®) and Chemotherapy in Chinese Patients With Her2-Positive Metastatic Breast Cancer Previously Treated With Trastuzumab

Phase II Study of Trastuzumab(Henlius®) Combined With Pertuzumab(Perjeta®) and Chemotherapy in Chinese Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer Previously Treated With Trastuzumab

NCT05188495•Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

Summary

Currently, data of the efficacy of trastuzumab plus pertuzumab and chemotherapy is limited in the HER2 positive metastatic breast cancer patients previously treated with trastuzumab during (neo)adjuvant and metastatic setting, and results are not consistent.The main purpose of this study is to evaluate the 6-month progression free survival(PFS) of trastuzumab(Henlius®) combined with Pertuzumab(Perjeta®) and Chemotherapy as first to third line therapy in Chinese patients with HER2 positive metastatic breast cancer who received trastuzumab previously.Primary Endpoint is 6-month Progression-free survival (PFS);Secondary Endpoint(s) include Progression-free survival (PFS) Overall Survival (OS);Objective Response Rate(ORR);

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Adults ≥18 years old
•2. Histologically confirmed invasive BC: incurable, immunohistochemistry (IHC) 3 + or fish confirmed gene amplification: HER2 / CEP 17 ratio ≥ 2, and either of the two analysis results is positive.
•3. Patients with metastatic breast cancer previously treated with trastuzumab 1) the number of lines receiving anti-HER2 treatment for metastatic diseases was 0-2 2) If the number of lines previously receiving anti-HER2 treatment for metastatic diseases is 0, it is required that the last time of preoperative( neoadjuvant) and / or postoperative (adjuvant) trastuzumab is more than 6 months before recurrence and metastasis.
•4. Measurable disease as defined per RECIST v.1.1. Patients with only central nervous system diseases are not suitable for inclusion.
•5. Left ventricular ejection fraction (LVEF) ≥ 50%, determined by echocardiography.
•6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
•7. Adequate organ and bone marrow function defined as follows,Confirmed by the following laboratory examination results within 7 days before randomization：
•* (1) Absolute Neutrophil Count (ANC) ≥1,500/mm3 (1.5 x 109 /L);
•* (2)Platelets ≥100,000/mm3 (100 x 109 /L);
•* (3) Hemoglobin ≥9 g/dL (90 g/L);（patients are allowed to reach these levels through blood transfusion or drug treatment）
+10 more criteria

Exclusion Criteria

•Patients presenting with any of the following will not be included in the study:
•1. History of receivingpatuzumab in the treatment of metastatic diseases (if used during adjuvant or neoadjuvant, the time from the last medication to recurrence and metastasis should be more than 12 months)
•2. History of other malignancy within the previous 5 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, synchronous or previously diagnosed HER2-positive BC, or cancers with a similar curative outcome as those mentioned above
•3. History of receiving chemotherapy or trastuzumab within 21 days before randomization (7 days in the case of weekly regimen)
•4. History of radiation therapy within 14 days before randomization
•5. Patients must recover from acute toxicity caused by previous treatment (to ≤ grade 1) before randomization.
•6. Untreated symptomatic progressive brain metastases occurred within 30 days before randomization.
•7. The cumulative dose of exposure to the following anthracyclines is detailed as follows:
•Doxorubicin \> 500 mg/m2 Epirubucin \> 720 mg/m2 Mitoxantrone \> 120 mg/m2 If other anthracyclines or several anthracyclines are used, the cumulative dose must be less than the equivalent dose of 500 mg / m2 adriamycin.
•8. Current unstable ventricular arrhythmia requiring treatment.
+8 more criteria

Locations (1)

Ruyan Zhang

Beijing, Beijing Municipality, China

Key Dates

Start Date

May 10, 2021

Primary Completion Date

December 10, 2023

Completion Date

December 10, 2023

Last Updated

January 12, 2022

Enrollment

ESTIMATED participants

Conditions

HER2-positive Metastatic Breast CancerPreviously Treated With TrastuzumabTrastuzumab Combined With Pertuzumab and Chemotherapy

Interventions

trastuzumab(Henlius®) combined with Pertuzumab(Perjeta®) and Chemotherapy

DRUG

Contacts

Ruyan Zhang

CONTACT

+861088196380 zhangruyan2016@163.com

Huiping Li

CONTACT

+861088196739 huipingli2012@hotmail.com

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Trastuzumab(Henlius®) Combined With Pertuzumab(Perjeta®) and Chemotherapy in Chinese Patients With Her2-Positive Metastatic Breast Cancer Previously Treated With Trastuzumab

Inclusion Criteria

Exclusion Criteria

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