Study to Evaluate the Efficacy and Safety of CDK4/6 Inhibitor SHR6390 Combined With Pyrotinib in the Treatment of HER2-positive Advanced Breast Cancer
Primary Purpose
Metastatic Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Pyrotinib combine with SHR6390
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Local recurrent or metastatic breast cancer suitable for chemotherapy, confirmed histologically.
- HER2-positive breast cancer(according to 2018 ASCO/CAP HER2 test guideline).
- Patients with HER2-positive metastatic breast cancer who had received ≤ 1-line treatment in the past;
- 18-70 years old.
- ECOG PS 0~1.
- life expectancy is not less than 12 weeks.
- at least one measurable lesion according to RECIST 1.1.
- ANC ≥ 2.0×109/L,PLT ≥ 100×109/L,Hb ≥ 90 g/L;TBIL≤1.5ULN;ALT and AST≤3×ULN(ALT and AST≤5×ULN if liver metastasis);BUN and Cr≤1.5×ULN
- LVEF ≥ 50% and QTc≤470 ms.
Exclusion Criteria:
- Patients with symptomatic brain metastasis;
- Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption.
- patient who received radiotherapy, chemotherapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks before admission; those who received anti-tumor endocrine therapy after screening period
- Participated in other drug clinical trials within 4 weeks before admission
- Tyrosine kinase inhibitors targeting HER2 (Neratinib, Lapatinib, pyrotinib, etc.) have been used or are being used in the past.
- Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
- A history of immunodeficiency, including HIV positive, HCV,, or other acquired, congenital immunodeficiency disorders, or organ transplantation, is known.
- Has suffered from any heart disease
- Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial
- According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).
- Moderate infection occurs within 4 weeks before the first administration (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs according to clinical criteria), fever(> 38.5 ℃) of unknown origin occurs during the screening period/before the first administration.
- Researchers believe that patients are not suitable for any other situation in this study.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental: Pyrotinib + SHR6390
Arm Description
Pyrotinib combine with SHR6390 should be administrate to all subjects. pyrotinib 400mg qd combined with SHR 6390 125mg qd
Outcomes
Primary Outcome Measures
Objective Response Rate
CR+PR
Secondary Outcome Measures
PFS
Progression-Free Survival
OS
Overall Survival
Full Information
NCT ID
NCT03993964
First Posted
June 13, 2019
Last Updated
June 20, 2019
Sponsor
Sun Yat-sen University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03993964
Brief Title
Study to Evaluate the Efficacy and Safety of CDK4/6 Inhibitor SHR6390 Combined With Pyrotinib in the Treatment of HER2-positive Advanced Breast Cancer
Official Title
A Multicenter, Phase II Open Label Study of Pyrotinib Maleate Combined With CDK4/6 Inhibitor SHR6390 in Treatment of HER2-positive Metastatic Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 15, 2019 (Anticipated)
Primary Completion Date
October 30, 2020 (Anticipated)
Study Completion Date
April 15, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The main purpose of this study was to observe the efficacy and safety of treatment with pyrotinib and CDK4/6 inhibitor SHR6390 for HER2-positive metastatic breast cancer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental: Pyrotinib + SHR6390
Arm Type
Experimental
Arm Description
Pyrotinib combine with SHR6390 should be administrate to all subjects. pyrotinib 400mg qd combined with SHR 6390 125mg qd
Intervention Type
Drug
Intervention Name(s)
Pyrotinib combine with SHR6390
Intervention Description
SHR6390 is a novel small molecule inhibitor specifically targeting the CDK4/6 pathway. Pyrotinib is an irreversible pan-ErbB inhibitor which shows promising antitumour activity in patients with HER2-positive metastatic breast cancer
Primary Outcome Measure Information:
Title
Objective Response Rate
Description
CR+PR
Time Frame
from enrollment to progression or death (for any reason), assessed up to 100 months
Secondary Outcome Measure Information:
Title
PFS
Description
Progression-Free Survival
Time Frame
from enrollment to progression or death (for any reason),assessed up to 100 months
Title
OS
Description
Overall Survival
Time Frame
from enrollment to death (for any reason).assessed up to 100 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Local recurrent or metastatic breast cancer suitable for chemotherapy, confirmed histologically.
HER2-positive breast cancer(according to 2018 ASCO/CAP HER2 test guideline).
Patients with HER2-positive metastatic breast cancer who had received ≤ 1-line treatment in the past;
18-70 years old.
ECOG PS 0~1.
life expectancy is not less than 12 weeks.
at least one measurable lesion according to RECIST 1.1.
ANC ≥ 2.0×109/L,PLT ≥ 100×109/L,Hb ≥ 90 g/L;TBIL≤1.5ULN;ALT and AST≤3×ULN(ALT and AST≤5×ULN if liver metastasis);BUN and Cr≤1.5×ULN
LVEF ≥ 50% and QTc≤470 ms.
Exclusion Criteria:
Patients with symptomatic brain metastasis;
Unable to swallow, chronic diarrhea and intestinal obstruction, there are many factors affecting drug use and absorption.
patient who received radiotherapy, chemotherapy, surgery (excluding local puncture) or molecular targeted therapy within 4 weeks before admission; those who received anti-tumor endocrine therapy after screening period
Participated in other drug clinical trials within 4 weeks before admission
Tyrosine kinase inhibitors targeting HER2 (Neratinib, Lapatinib, pyrotinib, etc.) have been used or are being used in the past.
Other malignant tumors, excluding cured cervical carcinoma in situ, skin basal cell carcinoma or skin squamous cell carcinoma, have been diagnosed in the past five years.
A history of immunodeficiency, including HIV positive, HCV,, or other acquired, congenital immunodeficiency disorders, or organ transplantation, is known.
Has suffered from any heart disease
Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial
According to the judgement of the researchers, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of research (including, but not limited to, severe hypertension, severe diabetes, active infections, etc.).
Moderate infection occurs within 4 weeks before the first administration (e.g. intravenous drip of antibiotics, antifungal or antiviral drugs according to clinical criteria), fever(> 38.5 ℃) of unknown origin occurs during the screening period/before the first administration.
Researchers believe that patients are not suitable for any other situation in this study.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study to Evaluate the Efficacy and Safety of CDK4/6 Inhibitor SHR6390 Combined With Pyrotinib in the Treatment of HER2-positive Advanced Breast Cancer
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