This study is to find out that if HER-2 positive and HR positive patients could benefit from trastuzumab and pertuzumab combined with palbociclib and endocrine therapy.
This study is a single-arm, open-label, multicenter, phase II clinical study. Subjects were eligible for screening and entered the trial period after enrollment and received treatment with palbociclib(125mg/day), trastuzumab(8 mg→6mg/every 3 week), pertuzumab(840 mg→420mg/every 3 week), combined with endocrine therapy until disease progression, or intolerable toxicity, or withdrawal of informed consent, or discontinuation of medication at the investigator 's discretion. On-study imaging assessments were performed according to RECIST 1.1 criteria and the site assessment was final.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
94
CDK4/6 inhibitor (Qilu) have got the cFDA approval and Trastuzumab (Hanquyou) have few data on combination use, this two drugs need clinical treatment data
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Yaxin Liu
Beijing, None Selected, China
Progression free survival(PFS)
calculated from the first administration time of the study drug to the disease progress or death. If the patient does not have PD or death on the study deadline, or has received other anti-tumor treatment, the deadline shall be the last efficacy evaluation result before the deadline or the start date of other anti-tumor treatment (whichever occurs first)
Time frame: 2 year
Objective response rate (ORR)
it refers to the proportion of patients who have the best response effect of CR or PR from the beginning of receiving the treatment plan of this study to the time when the patient's disease progresses out of the group. Tumor imaging examination shall be performed at baseline and every 2 cycles (6 weeks) thereafter. If the patient reaches CR or PR, it shall be confirmed after 6 weeks. If patients delay treatment due to toxicity, they still need to receive efficacy evaluation every 6 weeks.
Time frame: 2 year
Disease control rate (DCR)
refers to the proportion of patients who have achieved complete remission (CR), partial remission (PR) or stable disease (SD) at least once after receiving the treatment of this study protocol
Time frame: 2 year
Duration of remission (DoR)
from the date when CR or PR evidence was first found to the date when objective progress occurred or the date of death due to any reason, whichever is earlier. If the patient does not know whether the patient is PD or dead at the deadline of the study, the date of the last complete objective progression free disease assessment shall be taken as the data deletion.
Time frame: 2 year
Total survival (OS)
calculated from the first administration of the study drug to the death due to any reason.The OS of patients who still survived at the last follow-up is counted as the data deletion based on the time of the last follow-up. For patients who lost the interview, their OS was counted as data deletion based on the last confirmed survival time before the lost interview. The OS of data deletion is defined as the time from grouping to deletion
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Time frame: 2 year
time to treatment failure(TTF)
calculated from enrolled in the study to stop treatment resulted in any reason
Time frame: 2 year