Clinical Trials /

Study to Evaluate the Efficacy and Safety of CDK4/6 Inhibitor SHR6390 Combined With Pyrotinib in the Treatment of HER2-positive Advanced Breast Cancer

NCT03993964

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • 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

Clinical Trial IDs

  • ORG STUDY ID: HR-BLTN-014
  • NCT ID: NCT03993964

Conditions

  • Metastatic Breast Cancer

Interventions

DrugSynonymsArms
Pyrotinib combine with SHR6390Experimental: Pyrotinib + SHR6390

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
Experimental: Pyrotinib + SHR6390ExperimentalPyrotinib combine with SHR6390 should be administrate to all subjects. pyrotinib 400mg qd combined with SHR 6390 125mg qd
  • Pyrotinib combine with SHR6390

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.
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective Response Rate
Time Frame:from enrollment to progression or death (for any reason), assessed up to 100 months
Safety Issue:
Description:CR+PR

Secondary Outcome Measures

Measure:PFS
Time Frame:from enrollment to progression or death (for any reason),assessed up to 100 months
Safety Issue:
Description:Progression-Free Survival
Measure:OS
Time Frame:from enrollment to death (for any reason).assessed up to 100 months
Safety Issue:
Description:Overall Survival

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Sun Yat-sen University

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