Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04681911
Other study ID # 2020-KY-125
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date September 9, 2020
Est. completion date September 9, 2024

Study information

Verified date December 2020
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact Jianli Zhao
Phone 86-20-34070870
Email zhaojli5@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

HER2-targeted therapy after the failure of trastuzumab treatment has become a new difficulty and challenge. Inetetamab, a new antibody to optimize the ADCC effect, has become one of the second-line treatment options after trastuzumab fails, showing good survival benefits. Pyrotinib, another second-line HER2 targeted drug, is a typical representative of TKI drugs, which not only has a strong HER2 antagonistic effect but also can synergize with monoclonal antibodies to amplify the ADCC effect. Pyrotinib and Inetetamab showed excellent anti-tumor efficacy and good safety in TKI and optimized ADCC respectively. we plan to carry out a phase II single-arm clinical study to evaluate the efficacy and safety of "Inetetamab combined with Pyrotinib and chemotherapy" in the treatment of her positive metastatic breast cancer.


Description:

Trastuzumab is the first target drug for HER2 positive metastatic breast cancer, which can significantly improve the survival of patients with HER2 positive metastatic breast cancer and become the first-line standard treatment. However, the selection of second-line targeted drugs after the failure of trastuzumab treatment has become a new difficulty and challenge. Studies have shown that the ADCC effect is one of the main mechanisms of the anti-tumor effect of trastuzumab. Therefore, Inetetamab, a new antibody to optimize the ADCC effect, has become one of the second-line treatment options after trastuzumab fails, showing good survival benefits. Pyrotinib, another second-line HER2 targeted drug, is a typical representative of TKI drugs, which not only has a strong HER2 antagonistic effect but also can synergize with monoclonal antibodies to amplify the ADCC effect. As two important class 1.1 innovative drugs in China, Pyrotinib and Inetetamab showed excellent anti-tumor efficacy and good safety in TKI and optimized ADCC respectively. Considering that the current guidelines recommend the combination of multiple anti-HER2 targeted drugs, and basic research also shows that Pyrotinib and Inetetamab have a synergistic effect, we plan to carry out a phase II single-arm clinical study to evaluate the efficacy and safety of "Inetetamab combined with Pyrotinib and chemotherapy" in the treatment of her positive metastatic breast cancer, so as to provide better results for patients with HER2 positive metastatic breast cancer Treatment options!


Recruitment information / eligibility

Status Recruiting
Enrollment 71
Est. completion date September 9, 2024
Est. primary completion date September 9, 2023
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: Subjects must meet all of the following conditions: 1. Adult female patients (age 18-70 years) with metastatic breast cancer confirmed by pathology or imaging; 2. Pathological diagnosis of HER-2 was positive (definition: immunohistochemical results were + + + or in situ hybridization results were positive); 3. Received trastuzumab treatment in the past; 4. the patients have received 1-3 treatments for metastatic breast cancer in the past; 5. According to RECIST 1.1, patients with at least one target lesion or simple bone metastasis can be evaluated; 6. ECoG score of physical status was less than 2, and the expected survival time was not less than 3 months; 7. Prior treatment-related toxicity should be reduced to NCI CTCAE (version 5.0) = 1 degree (except for hair loss or other toxicity which is considered as no risk to patient's safety according to the investigator's judgment) 8)LVEF=50%; 9) Sufficient functional reserve of bone marrow 1. White blood cell count (WBC) = 3.0 × 10 ^ 9 / L, 2. Neutrophil count (ANC) = 1.5 × 10 ^ 9 / L, 3. Platelet count (PLT) = 100 × 10 ^ 9 / L 10) Previous treatment-related toxicity should be relieved as NCI CTCAE (version 5.0) = 1 degree, total bilirubin (TBIL) = 1.5 × upper limit of normal value (ULN), alanine aminotransferase (ALT / AST) = 2.5 × ULN (liver metastasis patients = 5xuln), serum creatinine = 1.5 × ULN or creatinine clearance rate (CCR) = 60 ml / min; 11) Be able to understand the research process, volunteer to participate in the study, and sign informed consent. Exclusion Criteria: Subjects were not allowed to participate in the study if they had any of the following conditions: 1. No trastuzumab treatment was received; 2. Have received more than 3 therapeutic regimens for metastatic breast cancer; 3. No treatment for metastatic breast cancer was received; 4. Patients who are known to be allergic to active or other components of the study drug. 5. They received radiotherapy, chemotherapy, endocrine therapy within 4 weeks before enrollment, or were participating in any clinical trials of intervention drugs; 6. Pregnant or lactating women, women of childbearing age who refused to take effective contraceptive measures during the study period. 7. Any other situation in which the researcher considers that the patient is not suitable for the study may interfere with the concomitant diseases or conditions involved in the study, or there are any serious medical barriers that may affect the safety of the subjects (e.g., uncontrollable heart disease, hypertension, active or uncontrollable infection, active hepatitis B virus infection)

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Inetetamab
Inetetamab: 8mg/kg for the first dose, 6mg/kg for the following doses, every 3 weeks for one cycle.
Pyrotinib
Pyrotinib: 400mg, oral, every day.
Capecitabine
Capecitabine, 1000 mg/m2, d1-d14, 3-week cycle
Gemcitabine
Gemcitabine, 1000 mg/m2, D1, D8, 3-week cycle
Vinorelbine
Vinorelbine, 25-30 mg/m2, D1, D8, 3-week cycle
Carboplatin
Carboplatin, AUC = 6, 3-week cycle
Albumin paclitaxel
Albumin paclitaxel, 100 mg/m2, weekly
Eribulin
Eribulin, 1.4 mg/m2, D1, D8, 3-week cycle

Locations

Country Name City State
China Sun Yat Sen Memorial Hospital,Sun Yat sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (3)

Li X, Yang C, Wan H, Zhang G, Feng J, Zhang L, Chen X, Zhong D, Lou L, Tao W, Zhang L. Discovery and development of pyrotinib: A novel irreversible EGFR/HER2 dual tyrosine kinase inhibitor with favorable safety profiles for the treatment of breast cancer. — View Citation

Ma F, Li Q, Chen S, Zhu W, Fan Y, Wang J, Luo Y, Xing P, Lan B, Li M, Yi Z, Cai R, Yuan P, Zhang P, Li Q, Xu B. Phase I Study and Biomarker Analysis of Pyrotinib, a Novel Irreversible Pan-ErbB Receptor Tyrosine Kinase Inhibitor, in Patients With Human Epi — View Citation

Ma F, Ouyang Q, Li W, Jiang Z, Tong Z, Liu Y, Li H, Yu S, Feng J, Wang S, Hu X, Zou J, Zhu X, Xu B. Pyrotinib or Lapatinib Combined With Capecitabine in HER2-Positive Metastatic Breast Cancer With Prior Taxanes, Anthracyclines, and/or Trastuzumab: A Rando — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Response Rate,ORR Objective response rate assessed at 18 weeks after enrollment,that is about 6 cycles of treatment 18 weeks after enrollment
Secondary Progression Free Survival,PFS The time from the beginning of treatment to the progression or death of the patient 2 years
Secondary overall survival,OS The time from the beginning of treatment to the death of the patient 4 years
Secondary Clinical Benefit Rate,CBR Clinical Benefit Rate assessed at 24 weeks after enrollment,that is about 8 cycles of treatment 24 weeks after enrollment
Secondary the rate of adverse events The probability and severity of adverse reactions were analyzed up to 24 weeks after enrollment up to 24 weeks after enrollment
Secondary Quality of life scale score,QoL The quality of life score of patients during treatment was analyzed(FACT-B). Performance Status Rating (PSR) was demonstrated for the FACT-B total score, which is the result of the following subscale scores: SWB (the Social / family Well-Being subscale) , EWB (the Emotional Well-Being subscale), AC (Additional Concerns subscale), PWB (the Physical Well-Being subscale), FWB (the Functional Well-Being subscale) 1 year
Secondary Exploration of biomarkers Objective to explore the correlation between biomarkers and the ORR. The biomarkers will be test by nest-generation sequence, which include 520 genes and tumor mutation burden, like ERBB2/TP53/PIK3CA/ERBB4/CCND1 and so on. the first week after the enrollment
See also
  Status Clinical Trial Phase
Terminated NCT04066790 - Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer Phase 2
Completed NCT04890327 - Web-based Family History Tool N/A
Completed NCT03591848 - Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility N/A
Recruiting NCT03954197 - Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients N/A
Terminated NCT02202746 - A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer Phase 2
Active, not recruiting NCT01472094 - The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
Completed NCT06049446 - Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
Withdrawn NCT06057636 - Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study N/A
Recruiting NCT05560334 - A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations Phase 2
Active, not recruiting NCT05501769 - ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer Phase 1
Recruiting NCT04631835 - Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer Phase 1
Completed NCT04307407 - Exercise in Breast Cancer Survivors N/A
Recruiting NCT03544762 - Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation Phase 3
Terminated NCT02482389 - Study of Preoperative Boost Radiotherapy N/A
Enrolling by invitation NCT00068003 - Harvesting Cells for Experimental Cancer Treatments
Completed NCT00226967 - Stress, Diurnal Cortisol, and Breast Cancer Survival
Recruiting NCT06006390 - CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors Phase 1/Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06019325 - Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy N/A
Recruiting NCT05622240 - 99mTc-MIRC213 SPECT/CT for the Detection of HER2-positive Breast Cancer Early Phase 1