A Phase 2 interventional study of Inetetamab and Pyrotinib in Breast Cancer, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Status unknown at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-12-23.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Phase 2, Interventional, and Treatment
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.
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!
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 71 is close to the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 466 studies on the registry; 271 are open to participants now.
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Subjects must meet all of the following conditions:
Exclusion Criteria:
Subjects were not allowed to participate in the study if they had any of the following conditions:
Inetetamab: 8mg/kg for the first dose, 6mg/kg for the following doses, every 3 weeks for one cycle. Pyrotinib: 400mg, oral, every day. Chemotherapy: the choice of physicians，as the following regimens: Capecitabine, 1000 mg/m2, d1-d14, 3-week cycle Gemcitabine, 1000 mg/m2, D1, D8, 3-week cycle Vinorelbine, 25-30 mg/m2, D1, D8, 3-week cycle Carboplatin, AUC = 6, 3-week cycle Albumin paclitaxel, 100 mg/m2, weekly Eribulin, 1.4 mg/m2, D1, D8, 3-week cycle
Drug: Inetetamab · Drug: Pyrotinib · Drug: Capecitabine · Drug: Gemcitabine · Drug: Vinorelbine · Drug: Carboplatin · Drug: Albumin paclitaxel · Drug: Eribulin
Inetetamab: 8mg/kg for the first dose, 6mg/kg for the following doses, every 3 weeks for one cycle.
Pyrotinib: 400mg, oral, every day.
Capecitabine, 1000 mg/m2, d1-d14, 3-week cycle
Also known as: xeloda or other names
Gemcitabine, 1000 mg/m2, D1, D8, 3-week cycle
Also known as: Gemzar or other names
Vinorelbine, 25-30 mg/m2, D1, D8, 3-week cycle
Also known as: Navelbine or other names
Carboplatin, AUC = 6, 3-week cycle
Also known as: Paraplatin or other names
Albumin paclitaxel, 100 mg/m2, weekly
Also known as: Abraxane or other names
Eribulin, 1.4 mg/m2, D1, D8, 3-week cycle
Also known as: Halaven
Objective Response Rate，ORR
Objective response rate assessed at 18 weeks after enrollment，that is about 6 cycles of treatment
Time frame: 18 weeks after enrollment
Progression Free Survival，PFS
The time from the beginning of treatment to the progression or death of the patient
Time frame: 2 years
overall survival，OS
The time from the beginning of treatment to the death of the patient
Time frame: 4 years
Clinical Benefit Rate，CBR
Clinical Benefit Rate assessed at 24 weeks after enrollment，that is about 8 cycles of treatment
Time frame: 24 weeks after enrollment
the rate of adverse events
The probability and severity of adverse reactions were analyzed up to 24 weeks after enrollment
Time frame: up to 24 weeks after enrollment
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)
Time frame: 1 year
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.
Time frame: the first week after the enrollment
Plan to share: No — As personal information of patients is involved, we decided not to share individual participant data of patients.
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University