A Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With Advanced Breast Cancer

March 11, 2021 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Open-label, Multicenter Phase II Study of TQB3616 Capsules Combined With Fulvestrant Injection in Subjects With HR-positive, HER2-negative Advanced Breast Cancer

This study is a multicenter, open-label, multi-cohort phase II clinical trials to evaluate the efficacy and safety of TQB3616 capsules combined with Fulvestrant injection in subjects with HR-positive and HER2-negative advanced and/or metastatic breast cancer, including Cohort 1 and Cohort 2. Each cohort will enroll 30-60 cases.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

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 Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100039
        • Recruiting
        • The Fifth Medical Center of PLA General Hospital
        • Principal Investigator:
          • Zefei Jiang, Doctor
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Not yet recruiting
        • Chongqing University Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Xiaohua Zeng, Doctor
    • Gansu
      • Lanzhou, Gansu, China, 730030
        • Not yet recruiting
        • Gansu Provincial Hostipal
        • Contact:
        • Principal Investigator:
          • Haiyun Huang, Doctor
        • Principal Investigator:
          • Jie Hao, Doctor
    • Guangdong
      • Guangzhou, Guangdong, China, 510062
        • Not yet recruiting
        • Guangdong General Hospital
        • Contact:
        • Principal Investigator:
          • Kun Wang, Doctor
      • Guangzhou, Guangdong, China, 510062
        • Not yet recruiting
        • Sun Yat-sen University Cancer Center
        • Contact:
        • Principal Investigator:
          • Yanxia Shi, Doctor
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Not yet recruiting
        • Guangxi Medical University Affiliated Tumor Hospital
        • Contact:
        • Principal Investigator:
          • Weimin Xie, Doctor
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Not yet recruiting
        • The Fourth Hospital of Hebei Medical University
        • Contact:
        • Principal Investigator:
          • Yunjiang Liu, doctor
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Not yet recruiting
        • Harbin medical university Affiliated Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Qingyuan Zhang, Doctor
    • Hunan
      • Changsha, Hunan, China, 410013
        • Not yet recruiting
        • Hunan Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Quzhang Ouyang, Doctor
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
        • Principal Investigator:
          • Jinhai Tang, Doctor
    • Liaoning
      • Dalian, Liaoning, China, 116027
        • Not yet recruiting
        • The Second Hospital of Dalian Medical University
        • Contact:
        • Principal Investigator:
          • Man Li, Doctor
      • Shenyang, Liaoning, China, 110042
        • Not yet recruiting
        • Liaoning cancer Hospital & Institute
        • Contact:
        • Principal Investigator:
          • Tao Sun, Doctor
    • Shanghai
      • Shanghai, Shanghai, China, 200123
        • Not yet recruiting
        • Shanghai East Hospital
        • Contact:
        • Principal Investigator:
          • Qun Li, Doctor
    • Shanxi
      • Xi'an, Shanxi, China, 710038
        • Not yet recruiting
        • The Second Affiliated Hospital of PLA Air Force Military Medical University
        • Contact:
        • Principal Investigator:
          • Haichuan Su, Doctor
      • Xi'an, Shanxi, China, 710061
        • Not yet recruiting
        • The First Affiliated Hospital of Xi'an Jiao Tong University
        • Principal Investigator:
          • Yu Ren, Doctor
        • Contact:
    • Xinjiang
      • Urumqi, Xinjiang, China, 830000
        • Not yet recruiting
        • Affiliated Tumor Hospital of Xinjiang Medical University
        • Contact:
        • Principal Investigator:
          • Bing Zhao, Doctor
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Not yet recruiting
        • The First Affiliated Hospital Zhejiang University School of Medicine
        • Principal Investigator:
          • Peng Shen
        • 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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 1.Understood and signed an informed consent form. 2.Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1; Life expectancy ≥ 3 months. 3. Histopathologically confirmed HR positive and HER2 negative advanced or metastatic breast cancer. 4.Cohort 1: patients had received ≤1 line of treatment. 5.Cohort 2: patients had not previously received systemic antitumor therapy. 6.Has at least one measurable lesion according to RECIST1.1 criteria. 7.Adequate laboratory indicators.

Exclusion Criteria:

  • 1. Concomitant disease and medical history:

    1. Has other malignant tumors within 3 years;
    2. Has multiple factors affecting oral medication;
    3. Unalleviated toxicity ≥ grade 1 due to any previous anticancer therapy;
    4. Has active or uncontrolled severe infections before the first dose;
    5. Cirrhosis, active hepatitis#
    6. Have a history of immunodeficiency; 2. Tumor-related symptoms and treatment:
    1. Has central nervous system metastases (CNS) and/or cancerous meningitis or leptomeningeal carcinomatosis;
    2. Had received chemotherapy within 3 weeks prior to the first dose, and had received radiotherapy , hormone therapy, or other anti-tumor therapy within 2 weeks prior to the first dose;

    3. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.

      3. Has known to be allergic to Fulvestrant injection , TQB3616 or any excipient.

      4. Has Participated in other clinical trials within 4 weeks before first dose. 5. According to the judgement of the investigators, there are other factors that may lead to the termination 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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQB3616 capsules combined with fulvestrant injection
TQB3616 capsules 180 mg given orally, once daily in 28-day cycle. Fulvestrant injection was given at a fixed dose of 500mg on day 1, day 15 of the first cycle and day 1 of each subsequent cycle, and each cycle is 28 days.
Drug: TQB3616 capsules
TQB3616 capsules 180 mg given orally, once daily in 28-day cycle.
Drug: Fulvestrant injection
Fulvestrant injection was given at a fixed dose of 500mg on day 1, day 15 of the first cycle and day 1 of each subsequent cycle, and each cycle is 28 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR) assessed by investigator
Time Frame: Baseline up to 24 months
ORR defined as percentage of participants achieving complete response (CR) and partial response (PR), recorded from the first dose until the first documented progressive disease (PD) or death from any cause, based on investigator.
Baseline up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: Baseline up to 24 months
PFS defined as the time from first dose until the first documented progressive disease (PD) or death from any cause.
Baseline up to 24 months
Overall survival (OS)
Time Frame: Baseline up to 24 months]
OS defined as the time from first dose to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.
Baseline up to 24 months]
Clinical benefit rate (CBR)
Time Frame: Baseline up to 24 months
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Baseline up to 24 months
Duration of Response (DOR)
Time Frame: Baseline up to 24 months
The time when the participants first achieved complete or partial remission to disease progression.
Baseline up to 24 months

Collaborators and Investigators

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

Sponsor

Chia Tai Tianqing Pharmaceutical Group 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)

February 4, 2021

Primary Completion (Anticipated)

January 31, 2023

Study Completion (Anticipated)

January 31, 2023

Study Registration Dates

First Submitted

March 11, 2021

First Submitted That Met QC Criteria

March 11, 2021

First Posted (Actual)

March 15, 2021

Study Record Updates

Last Update Posted (Actual)

March 15, 2021

Last Update Submitted That Met QC Criteria

March 11, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQB3616-II-01

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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