HER2-positive Breast Cancer Project Initiated by Investigators

April 20, 2022 updated by: Xichun Hu, Fudan University

An Open-clinical Trial Phase Ⅱ, Injection of A166 for HER2-positive Patients With Refractory Unresectable Locally Advanced or Metastatic Breast Cancer；KL166-IIS-001

This study will assess the objective response rate (ORR), safety, progression-free survival (PFS) , overall survival (OS), 6-month survival rate, 12-month survival rate, 18-month survival rate, 24-month survival rate, disease control rate (DCR), clinical benefit rate (CBR), duration of response (DOR) and Time to Response (TTR). Injection of A166 for HER2-positive patients with refractory unresectable locally advanced or metastatic breast cancer who have failed previous ADC drug therapy.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

48

Phase

  • Phase 2

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

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. Male or female patient ≥ 18 years and ≤ 75 years when signing the informed consent form; 2. Breast cancer patients by histopathology and/or cytology documented, including:

    a) Participants with unresectable locally advanced or metastatic breast cancer; b) Evaluated or tested as HER2-positive expression. The definition of HER2 positive in this study: immunohistochemistry (IHC) was 2+ and confirmed by fluorescence in situ hybridization (FISH), or IHC was 3+; 3. Have received at least 3 targeted therapies for locally advanced or metastatic disease, including:

    1. Disease progression after receiving at least 1 trastuzumab-containing (including a biosimilar of trastuzumab on the market)-based treatment;
    2. After receiving at least one anti-HER2 tyrosine kinase inhibitor (lapatinib or pyrrotinib)-based treatment plan, the disease progresses or cannot tolerate toxic and side effects;

    3. The disease progresses or cannot tolerate toxic and side effects after receiving treatment with antibody-conjugated drugs targeting HER2 (such as T-DM1 or other ADCs); Note: Adjuvant therapy and anti-HER2 therapy used in the neoadjuvant treatment stage before radical treatment are not counted, but recurrence or metastasis occurs during the last anti-HER2 medication period or within one year after the end, it can be regarded as a plan.

      4. Have previously received taxanes to treat breast cancer;

      Exclusion Criteria:

  • 1. Serious or uncontrollable heart diseases that require treatment, including:

    1. Congestive heart failure graded 3 or 4 by the New York College of Cardiology (NYHA);
    2. Unstable angina pectoris that cannot be controlled by drugs;
    3. Myocardial infarction occurred within 6 months before the first administration of the study treatment;
    4. Severe arrhythmia requiring medical treatment (except for atrial fibrillation or paroxysmal supraventricular tachycardia); 2. Baseline measurement, QTc interval, male> 450 msec, female> 470 msec; 3. Clinically active interstitial lung disease; 4. Patients with primary central nervous system (CNS) malignant tumors or CNS metastases that have failed local treatment; for asymptomatic brain metastases, or with stable clinical symptoms and no need for steroids and other brain metastases within 4 weeks before the first administration of the trial drug Treated patients can be included in the group; 5. Those who are known to have a history of hypersensitivity to other monoclonal antibodies or allergic to A166 and its components for injection; 6. Those who have permanently discontinued trastuzumab due to any toxicity;

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Group Assignment
This study adopts an open research design and selects patients with refractory HER2-positive unresectable locally advanced or metastatic breast cancer who have failed previous ADC drug treatment. The patients who met the enrollment conditions were treated with injection of A166.
Drug: Injection of A166
4.8 mg/kg for each 21 (±3) -day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate（ORR）
Time Frame: 2 years
ORR is defined as the percentage of subjects who have achieved complete response and partial response according RECIST 1.1.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival(PFS)
Time Frame: 2 years
PFS is defined as the time between date of first dose of study therapy and date of progression or death according RECIST 1.1.
2 years
Disease control rate(DCR)
Time Frame: 2 years
DCR is defined as cases where objective remission(assessed as complete remission or partial remission according RECIST 1.1 standard) or stable disease during the study.
2 years
Clinical benefit rate(CBR)
Time Frame: 2 years
CBR is defined as the proportion of patients with a complete or partial response or with stable disease according RECIST 1.1
2 years
Duration of rate(DOR)
Time Frame: 2 years
DOR is defined the time between the first tumor evaluation for CR or PR and the first evaluation for PD(Progressive Disease) or death from any cause according RECIST 1.1.
2 years
Time to response(TTR)
Time Frame: 2 years
TTP is defined as the time between randomization and objective tumor progression according RECIST 1.1; TTP does not include death
2 years
Overall survival(OS)
Time Frame: 2 years
Overall survival(OS) is defined as the time from first dose of study therapy to the date of death(any case).Subjects who are alive censored at the last known time that the subject was alive.
2 years

Collaborators and Investigators

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

Sponsor

Fudan University

Investigators

  • Principal Investigator: Xichun Hu, Doctor, Chief Physician

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

January 14, 2022

First Submitted That Met QC Criteria

April 20, 2022

First Posted (Actual)

April 26, 2022

Study Record Updates

Last Update Posted (Actual)

April 26, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KL166-IIS-001

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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