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Palbociclib Combine With Anti-HER2 Therapy in Triple Positive ABC

Primary Purpose

Breast Neoplasm Female

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
CDK4/6 inhibitor (Qilu),Trastuzumab (Hanquyou)
Sponsored by
Peking University Cancer Hospital & Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasm Female

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Sign the informed consent form and agree to comply with the requirements of the research protocol Recurrent or metastatic breast cancer confirmed by histology or cytology that cannot be operated, and has not received systematic treatment for recurrent or metastatic breast cancer. Estrogen receptor ER is positive (positive staining of ≥ 1% of tumor cell nucleus is positive) and HER2 is positive (immunohistochemistry is 3+, and/or 2+, and ISH is positive) Age ≥ 18 years old. ECOG physical status score is 0-1. Life expectancy ≥ 3 months. Be in a postmenopausal state. Suffer from one of the following diseases defined in RECIST 1.1, and the target lesion is not suitable for surgical treatment; The target lesion has not received radiotherapy or relapses in the radiotherapy field: At least one measurable lesion as the target lesion confirmed by CT or MRI Non measurable disease with only bone metastasis (osteogenic disease, osteolytic disease or osteolytic osteogenic mixture) Appropriate hematopoietic function, liver function and kidney function Exclusion Criteria: Visceral crisis, severe organ dysfunction accompanied by clinical symptoms and signs, and the clinician judges that it is necessary to receive chemotherapy based treatment as soon as possible to obtain disease relief, including but not limited to the following situations: liver metastasis accompanied by a rapid increase of more than 1.5 times of bilirubin or more than 3 times of transaminase; Or pulmonary metastasis with dyspnea at rest; Carcinomatous lymphangitis; Bone marrow metastasis was accompanied by severe decrease of hematopoietic function; As well as asthma, inflammatory breast cancer, etc. The subject has cancerous meningitis or has untreated central nervous system metastasis; Those who have received systematic and radical brain metastasis treatment (radiotherapy or surgery) in the past, and have been stable for at least 1 month as confirmed by imaging, and have stopped systemic hormone treatment (dose>10mg/day prednisone or other effective hormones) for more than 2 weeks, and have no clinical symptoms can be included. over 2 kind of Systematic treatment for metastatic breast cancer, including chemotherapy, endocrine therapy and biological targeting therapy, has been used previously. Have received any treatment of CDK4 and CDK6 inhibitors (or participated in any clinical trial of CDK4 and CDK6 inhibitors that have not been exposed). Have received radiotherapy within 28 days before enrollment. It is allowed to receive radiotherapy for relieving metastatic bone pain before enrollment, but the irradiated medullary bone shall not exceed 30% of the total amount. Patients with uncontrolled lung disease, severe infection, active digestive tract ulcer requiring treatment, coagulation disorders, severe uncontrolled diabetes, connective tissue disease or bone marrow function depression and other diseases cannot tolerate the study drug treatment.

Sites / Locations

  • Beijing Cancer Hospital
  • Yaxin LiuRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

four-drug treatment group

Arm Description

CDK4/6 inhibitor (Qilu): 125mg, oral Qd from the 1st to the 21st day of the 28 day cycle Trastuzumab (Hanquyou): on the first day of the 21 day cycle, the initial dose was 8mg/kg, and the intravenous infusion was 90 minutes; Every 3 weeks thereafter, the dose is 6mg/kg, and the intravenous infusion is 30~90 minutes Pertuzumab: on the first day of the 21 day cycle, the initial dose was 840mg, intravenous infusion was 60 minutes, and then once every 3 weeks, the dose was 420mg, and the infusion time was 30-60 minutes. Letrozole selected by the doctor: 2.5mg, oral Q24H or exemestane from the 1st to the 21st day of the 21 day cycle: 25mg, oral Q24H from the 1st to the 21st day of the 21 day cycle. The efficacy is evaluated every 2 months (CR, PR, SD, PD).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.
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
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.
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
time to treatment failure(TTF)
calculated from enrolled in the study to stop treatment resulted in any reason

Full Information

First Posted
December 14, 2022
Last Updated
July 31, 2023
Sponsor
Peking University Cancer Hospital & Institute
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1. Study Identification

Unique Protocol Identification Number
NCT05969184
Brief Title
Palbociclib Combine With Anti-HER2 Therapy in Triple Positive ABC
Official Title
Palbociclib Combine With Endocrine Therapy and Anti-HER2 Therapy in HR Positive and HER2 Positive Advanced Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 25, 2021 (Actual)
Primary Completion Date
December 25, 2023 (Anticipated)
Study Completion Date
December 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University Cancer Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm Female

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
we have only one single center participant and none of the roles in research needed to be mask
Allocation
N/A
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
four-drug treatment group
Arm Type
Experimental
Arm Description
CDK4/6 inhibitor (Qilu): 125mg, oral Qd from the 1st to the 21st day of the 28 day cycle Trastuzumab (Hanquyou): on the first day of the 21 day cycle, the initial dose was 8mg/kg, and the intravenous infusion was 90 minutes; Every 3 weeks thereafter, the dose is 6mg/kg, and the intravenous infusion is 30~90 minutes Pertuzumab: on the first day of the 21 day cycle, the initial dose was 840mg, intravenous infusion was 60 minutes, and then once every 3 weeks, the dose was 420mg, and the infusion time was 30-60 minutes. Letrozole selected by the doctor: 2.5mg, oral Q24H or exemestane from the 1st to the 21st day of the 21 day cycle: 25mg, oral Q24H from the 1st to the 21st day of the 21 day cycle. The efficacy is evaluated every 2 months (CR, PR, SD, PD).
Intervention Type
Drug
Intervention Name(s)
CDK4/6 inhibitor (Qilu),Trastuzumab (Hanquyou)
Other Intervention Name(s)
Pertuzumab,Letrozole,exemestane
Intervention Description
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
Primary Outcome Measure Information:
Title
Progression free survival(PFS)
Description
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
Secondary Outcome Measure Information:
Title
Objective response rate (ORR)
Description
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
Title
Disease control rate (DCR)
Description
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
Title
Duration of remission (DoR)
Description
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
Title
Total survival (OS)
Description
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
Time Frame
2 year
Title
time to treatment failure(TTF)
Description
calculated from enrolled in the study to stop treatment resulted in any reason
Time Frame
2 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Sign the informed consent form and agree to comply with the requirements of the research protocol Recurrent or metastatic breast cancer confirmed by histology or cytology that cannot be operated, and has not received systematic treatment for recurrent or metastatic breast cancer. Estrogen receptor ER is positive (positive staining of ≥ 1% of tumor cell nucleus is positive) and HER2 is positive (immunohistochemistry is 3+, and/or 2+, and ISH is positive) Age ≥ 18 years old. ECOG physical status score is 0-1. Life expectancy ≥ 3 months. Be in a postmenopausal state. Suffer from one of the following diseases defined in RECIST 1.1, and the target lesion is not suitable for surgical treatment; The target lesion has not received radiotherapy or relapses in the radiotherapy field: At least one measurable lesion as the target lesion confirmed by CT or MRI Non measurable disease with only bone metastasis (osteogenic disease, osteolytic disease or osteolytic osteogenic mixture) Appropriate hematopoietic function, liver function and kidney function Exclusion Criteria: Visceral crisis, severe organ dysfunction accompanied by clinical symptoms and signs, and the clinician judges that it is necessary to receive chemotherapy based treatment as soon as possible to obtain disease relief, including but not limited to the following situations: liver metastasis accompanied by a rapid increase of more than 1.5 times of bilirubin or more than 3 times of transaminase; Or pulmonary metastasis with dyspnea at rest; Carcinomatous lymphangitis; Bone marrow metastasis was accompanied by severe decrease of hematopoietic function; As well as asthma, inflammatory breast cancer, etc. The subject has cancerous meningitis or has untreated central nervous system metastasis; Those who have received systematic and radical brain metastasis treatment (radiotherapy or surgery) in the past, and have been stable for at least 1 month as confirmed by imaging, and have stopped systemic hormone treatment (dose>10mg/day prednisone or other effective hormones) for more than 2 weeks, and have no clinical symptoms can be included. over 2 kind of Systematic treatment for metastatic breast cancer, including chemotherapy, endocrine therapy and biological targeting therapy, has been used previously. Have received any treatment of CDK4 and CDK6 inhibitors (or participated in any clinical trial of CDK4 and CDK6 inhibitors that have not been exposed). Have received radiotherapy within 28 days before enrollment. It is allowed to receive radiotherapy for relieving metastatic bone pain before enrollment, but the irradiated medullary bone shall not exceed 30% of the total amount. Patients with uncontrolled lung disease, severe infection, active digestive tract ulcer requiring treatment, coagulation disorders, severe uncontrolled diabetes, connective tissue disease or bone marrow function depression and other diseases cannot tolerate the study drug treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huiping Li, Dr
Phone
01088196380
Email
huipingli2012@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yaxin Liu, Dr
Phone
01088196380
Email
liuyaxin0625@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaxin Liu, Dr
Organizational Affiliation
Peking University Cancer Hospital and Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Active, not recruiting
Facility Name
Yaxin Liu
City
Beijing
State/Province
None Selected
ZIP/Postal Code
100042
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yaxin Liu
Phone
01088196380
Email
liuyaxin0625@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
research plan would be share after completion of patients enroment.

Learn more about this trial

Palbociclib Combine With Anti-HER2 Therapy in Triple Positive ABC

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