A Phase Ⅲ Study of the Efficacy and Safety of Hemay022+Aromatase Inhibitor(AI) in Participants With ER+/HER2+ Advanced or Metastatic Breast Cancer (Fillful-03)

July 1, 2022 updated by: Tianjin Hemay Oncology Pharmaceutical Co., Ltd

A Randomized, Multicenter, Parallel,Phase III Open-label Study of the Efficacy and Safety of Hemay022 + AI in Patients With ER+/HER2+ Advanced or Metastatic Breast Cancer Who Have Received Prior Trastuzumab-Based Therapy

This is a Phase III, randomized, multicenter, 2-arm, open-label clinical trial designed to compare the safety and efficacy of Hemay022+Aromatase inhibitor(AI) with that of capecitabine + lapatinib in participants with ER+/HER2+ locally advanced or metastatic breast cancer. Participants will be treated until disease progression (PD), unmanageable toxicity, or study termination. Once disease progression is reported, all participants will be followed for survival every 3 months until death, loss to follow-up.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

339

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Age ≥18 years old；
  2. Subjects must give informed consent to the study before the study entry and voluntarily sign a written informed consent form;
  3. Breast cancer subjects diagnosed by pathology;
  4. ER positive and HER2 over-expression;
  5. Advanced/metastatic breast cancer that has previously received treatment failure with trastuzumab (or trastuzumab biosimilar) regimen;
  6. Measurable and/or nonmeasurable disease;
  7. (Eastern Cooperative Oncology Group)ECOG Performance Status of 0-1;
  8. The estimated survival time is more than 3 months;
  9. Postmenopausal women;
  10. Adequate bone marrow, liver, kidney, and coagulation Bone Marrow Function;
  11. All previous treatment-related toxicities must be Common Terminology Criteria of Adverse Events (CTCAE ,version 5.0) ≤ Grade 2 at the time of randomization, except for hair loss, pigmentation, and long-term toxicity caused by radiotherapy (which cannot be recovered by the investigator's judgment)；
  12. Women patients of childbearing age (including their partners) have no pregnancy plan and voluntarily take effective contraceptive measures from the signing of the informed consent form to 3 months after the last medication.

Exclusion Criteria:

  1. Patients with visceral crisis;
  2. Patients with the presence of spinal cord compression or brain, meningeal metastases;
  3. Patients who have been treated with a small molecule HER2 tyrosine kinase inhibitor (HER2-TKI) (medication course ≤2 weeks is excluded)
  4. Have received radiotherapy within 4 weeks prior to study；
  5. Have received chemotherapy for advanced breast cancer> 1 lines ;
  6. Patients with parenteral nutrition; malabsorption syndrome; or any condition possibly affecting drug absorption or inability to tolerate oral medications;
  7. Use of any drug that inhibits or induces hepatic metabolism of Hemay022 within 2 weeks prior to study and entire study duration;
  8. Patients who are known to have a history of allergies to Hemay022, lapatinib、AI (letrozole, exemestane) capecitabine or similar drugs;
  9. Left ventricular ejection fraction (LVEF) <50％;
  10. Positive blood for human immunodeficiency virus (HIV antibody); Positive hepatitis B surface antigen and HBV-DNA>upper limit of normal; Active hepatitis C virus (HCV) infection
  11. Patients with active infection requiring intravenous anti-infective treatment
  12. Arrhythmias requiring treatment ;
  13. Confirmed QTc prolongation (≥500ms) ;
  14. People with a history of interstitial lung disease that needs treatment, a history of radiation pneumonitis, or clinically active interstitial lung disease
  15. Have received other clinical trial drugs within 4 weeks before the study
  16. Major surgery or injury less than 4 weeks before the study
  17. The study period must be accompanied by other antitumor therapy，such as chemotherapy, targeted therapy, hormone therapy, immunotherapy, radiotherapy (except symptomatic local radiotherapy)
  18. Any other malignant cancer within 5 years with the exception of adequately treated cervical cancer in situ or basal and squamous cutaneous cell carcinomas
  19. Any condition that would make the subject inappropriate for this study by the investigator's judgment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hemay022 and AI
Hemay022 in combination with AI will be taken orally once daily. Planned dose of Hemay022 will be 500mg daily for 21 days.
Drug: Hemay022+AI
hemay022：orally once daily，A 21-day cycle
Active Comparator: Lapatinib and Capecitabine
lapatinib in combination with capecitabine will be taken in suitable dose until disease progression or death, etc.
Drug: Lapatinib+Capecitabine
Take the pills according to the instructions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median progression-free survival（mPFS）based on Independent Review Committee (IRC) assessment according to RECIST v1.1
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 month
PFS defined as the proportion of patients alive and without progression
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS) of the two group according to RECIST v1.1
Time Frame: From date of randomization until the date of death from any cause, whichever came first,assessed up to 36 months
OS is defined as the time from random to any cause of death
From date of randomization until the date of death from any cause, whichever came first,assessed up to 36 months
Objective response rate ( ORR, partial response rate+ complete response rate) according to RECIST v1.1
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 month
ORR defined as the proportion of subjects in complete response (CR) or (partial response) PR
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 month
Clinical benefit rate (CBR) according to RECIST v1.1
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 month
Clinical benefit rate defined as percentage of patients with stable disease (SD) ≥ 6 months/partial response (PR)/complete response (CR)
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 month
Duration of Response (DOR) according to RECIST v1.1
Time Frame: From the first recorded CR or PR until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 month
DOR defined as the duration after the first assessment as CR or PR, only applicable to subjects who have achieved remission
From the first recorded CR or PR until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 month
Time to Response (TTR)
Time Frame: From date of randomization until the date of the first recorded CR or PR assessed up to 36 month
TTR defined as the time from random to CR or PR for the first time
From date of randomization until the date of the first recorded CR or PR assessed up to 36 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Hemay Oncology Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2022

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

October 26, 2021

First Submitted That Met QC Criteria

November 4, 2021

First Posted (Actual)

November 16, 2021

Study Record Updates

Last Update Posted (Actual)

July 6, 2022

Last Update Submitted That Met QC Criteria

July 1, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM022BC3C01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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