Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer

June 3, 2024 updated by: Zhimin Shao, Fudan University

Study of Efficacy of Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Advanced Breast Cancer (Open, Randomized, Phase III)

This is a randomized, controlled, open-label, phase III study to explore the efficacy and safety of Apatinib in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF4 subtype of advanced breast cancer. The study was used to explore the efficacy of Apatinib in combination with standard endocrine therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

184

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 Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Inclusion Criteria:

  • Patients need to meet all of the following conditions

    • Patients must be ≥18 and ≤ 75 years of age;
    • Pathologically confirmed breast cancer is HR+/HER2- breast cancer (IHC ER >10%, or/and PR>10%, HER 0 OR +, if HER2++, FISH negative);
    • SNF4 subtype definition: SNF4 subtype confirmed by digital pathology of H&E sections;
    • Locally advanced breast cancer (radical local therapy is not possible) or metastatic breast cancer (without using adjuvant CDK4/6 inhibitors in the past, or one year after adjuvant CDK4/6 inhibitor therapy has ended);
    • No prior therapy (chemotherapy, targeted therapy, etc.) for advanced or metastatic breast cancer;
    • Patients with at least one measurable lesion that has not previously received radiation therapy and can be evaluated repeatedly according to RECIST 1.1;

    • The functions of the main organs are basically normal, and the following conditions are met:

      1. Blood routine examination standards should meet: HB≥90g/L (no blood transfusion within 14 days); ANC≥1.5×109/L; PLT≥75×109/L;
      2. Biochemical examination shall meet the following standards: TBIL≤1.5×ULN (upper limit of normal value); ALT and AST≤3 x ULN; In case of liver metastasis, ALT and AST≤5×ULN; Serum Cr ≤1.5×ULN, endogenous creatinine clearance > 50ml/min (Cockcroft-Gault formula);
    • ECOG performance status 0 or 1; The expected survival is more than 3 months;
    • Fertile female is required to use a medically approved contraceptive during study treatment and for at least 3 months after the last use of the study drug;
    • Patients voluntarily join the study, sign the informed consent, have good compliance, and cooperate with follow-up.

Exclusion Criteria:

  • Patients with any of the following conditions were excluded from the study

    • Patients with central nervous system metastasis out of control (symptoms need to use glucocorticoids or mannitol).
    • A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;
    • Radiotherapy, chemotherapy, surgery, other targeted therapy, and immunotherapy for advanced HR+/HER2- breast cancer within 4 weeks before the first administration of drugs used in this study.
    • Pregnant or lactating patients;
    • Other malignancies within the previous 3 years, excluding cured skin basal cell carcinoma and cervical carcinoma in situ;
    • Significant comorbid medical conditions, including mental illnesses that the investigator or sponsor believes would adversely affect the patient's participation in the study;
    • Allergic physique, or known allergic history of the drug components of this program; Or allergic to other monoclonal antibodies;
    • The investigator does not consider the patient suitable for participation in any other circumstances of the study.

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: Arm-A
Apatinib combined with cdk4/6i and Endocrine therapy.
Drug: Apatinib
Apatinib is a kind of TKI inhibitor.
Drug: CDK4/6 Inhibitor
Dalpiciclib (SHR6390) is a kind of CDK4/6 inhibitor that has demonstrated tolerability and preliminary clinical activity in patients with heavily pretreated hormone receptor-positive, HER2-negative advanced breast cancer.
Drug: Aromatase inhibitor and Fulvestrant
Endocrine therapy combined with CDK4/6 inhibitors is the standard first-line therapy for advanced luminal breast cancer. Investigators choose endocrine therapy including Letrozole, Anastrozole, Exemestane, and Fulvestrant. Postmenopausal participants should use Goserelin.
Active Comparator: Arm-B
cdk4/6i and Endocrine therapy.
Drug: CDK4/6 Inhibitor
Dalpiciclib (SHR6390) is a kind of CDK4/6 inhibitor that has demonstrated tolerability and preliminary clinical activity in patients with heavily pretreated hormone receptor-positive, HER2-negative advanced breast cancer.
Drug: Aromatase inhibitor and Fulvestrant
Endocrine therapy combined with CDK4/6 inhibitors is the standard first-line therapy for advanced luminal breast cancer. Investigators choose endocrine therapy including Letrozole, Anastrozole, Exemestane, and Fulvestrant. Postmenopausal participants should use Goserelin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival (PFS)
Time Frame: Approximately 5 years
The interval from randomization until the first occurrence of disease progression (according to RECIST 1.1) or death from any cause, which ever occurs first.
Approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Benefit Rate (CBR)
Time Frame: Approximately 5 years
CBR is the total percentage of participants who achieved a complete response, partial response, or had stable disease for 6 months or more.
Approximately 5 years
Objective Response Rate (ORR)
Time Frame: Approximately 5 years
ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR) based on BICR and investigator assessment using RECIST 1.1.
Approximately 5 years
Overall Survival (OS)
Time Frame: Approximately 5 years
OS is defined as the time from randomisation until the date of death due to any cause.
Approximately 5 years
Safety and tolerability
Time Frame: Approximately 5 years
Number of adverse events according to NCI-CTCAE Version 5.0 per each treatment arm.
Approximately 5 years

Collaborators and Investigators

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

Sponsor

Fudan University

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)

February 1, 2024

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 3, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

June 7, 2024

Last Update Submitted That Met QC Criteria

June 3, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCHBCC-N068

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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