Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer

April 7, 2026 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Evaluation of the Efficacy and Safety of TQB3616 Capsules Combined With Hormonal Therapy in a Phase II Clinical Trial for Cyclin-dependent Kinases 4 and 6（CDK4/6)Inhibitor-Resistant, Hormone Receptor(HR)-Positive, Human Epidermal Growth Factor Receptor 2(HER2)-Negative Recurrent/Metastatic Breast Cancer

Evaluation of the Efficacy and Safety of TQB3616 Capsules Combined with Hormonal Therapy in a Phase II Clinical Trial for Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor-Resistant, HR-Positive, HER2-Negative Recurrent/Metastatic Breast Cancer.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Quchang Ou Yang, Doctor
  • Phone Number: 13973135318
  • Email: oyqc1969@126.com

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233000
        • The First Affilliated Hospital of Bengbu Medical University
    • Guangdong
      • Jiangmen, Guangdong, China, 529000
        • Jiangmen Central Hospital
    • Hebei
      • Xingtai, Hebei, China, 54000
        • Xingtai People's Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Harbin Medical University Cancer Hostipal
    • Henan
      • Luohe, Henan, China, 462000
        • Luohe Central Hospital
    • Hunan
      • Changsha, Hunan, China, 410010
        • Hunan Cancer Hospital
    • Jiangsu
      • Nanjing, Jiangsu, China, 210003
        • Jiangsu Provincial People's Hospital
      • Nantong, Jiangsu, China, 226600
        • Hai'an People's Hospital
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Liaoning Cancer Hospital
    • Shandong
      • Jinan, Shandong, China, 250117
        • Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)
    • Shanxi
      • Xi’an, Shanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiao Tong University
    • Sichuan
      • Luzhou, Sichuan, China, 646000
        • The Affiliated Hospital of Southwest Medical University
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300202
        • Tianjin Medical University Cancer Institute & 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects voluntarily join the study, sign the informed consent form, and have good compliance
  • Aged 18 to 75 years, with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0~1; expected survival time of more than 3 months.
  • Postmenopausal or premenopausal/perimenopausal female patients
  • Progressed after prior treatment with CDK4/6 inhibitors
  • At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
  • Good major organ function
  • Women of childbearing potential must agree to use contraception during the study and for 6 months after its completion.

Exclusion Criteria:

  • Subjects with a previous pathological diagnosis of HER2-positive breast cancer.
  • Subjects with inflammatory breast cancer or occult breast cancer.
  • Subjects who have had or currently have other malignant tumors within 5 years prior to randomization.
  • Subjects with unresolved toxicity (greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1) from prior treatment, excluding alopecia.
  • Subjects who have undergone major surgical procedures, incisional biopsies, or significant traumatic injuries within 28 days prior to the first dose.
  • Subjects with non-tumor-related unresolved wounds, ulcers, or fractures.
  • Subjects with multiple factors affecting oral medication intake and absorption.
  • Subjects with arterial or deep vein thrombotic events within 6 months prior to the first dose.
  • Subjects with ≥ Grade 2 myocardial ischemia or myocardial infarction, arrhythmia, angina requiring anti-anginal medication, clinically significant valvular heart disease, or uncontrolled hypertension.
  • Subjects with a history of interstitial lung disease/pneumonitis (non-infectious) requiring steroid intervention or currently having interstitial lung disease/pneumonitis, or subjects with suspected interstitial lung disease/pneumonitis on screening imaging that cannot be excluded.
  • Subjects with active or uncontrolled serious infections (≥CTCAE Grade 2 infection) or unexplained fever >38.5°C within 28 days prior to the first dose.
  • Subjects with a history of abuse of psychotropic drugs that cannot be abstained from or those with psychiatric disorders.
  • Subjects with (pseudo) cirrhosis, active hepatitis.
  • Subjects with renal failure requiring hemodialysis or peritoneal dialysis.
  • Subjects with a history of immunodeficiency diseases, organ transplants, or hematopoietic stem cell transplants.
  • Subjects who have previously received fulvestrant or other oral Selective Estrogen Receptor Degrader (SERD) class drugs.
  • Subjects who have previously received anti-HER2 therapy.
  • Subjects who have previously received antibody-drug conjugate therapy.
  • Subjects who have participated in other anti-tumor clinical trials and taken investigational drugs within 4 weeks prior to the first dose.
  • Subjects judged by the investigator to have serious accompanying diseases that severely endanger the safety of the subject or affect the completion of the study, or subjects who are deemed unsuitable for enrollment for other reasons

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TQB3616 capsule+Fulvestrant Injection
Drug: TQB3616 capsule+Fulvestrant Injection
TQB3616 capsule is a CDK2/4/6 inhibitor and Fulvestrant injection is an anti-estrogen medication, and its pharmacological mechanism mainly exerts its therapeutic effect by inhibiting the action of aromatase.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: Baseline up to 12 months
The proportion of patients achieving complete response and partial response among the total evaluable cases.
Baseline up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: Baseline up to 12 months
Progression Free Survival (PFS) is defined as the length of time from the start of treatment until the disease progresses or the patient dies from any cause.
Baseline up to 12 months
Duration of Response
Time Frame: Baseline up to 12 months
The time from the first assessment of the tumor as a complete response or partial response to the first occurrence of disease progression or death from any cause.
Baseline up to 12 months
Disease Control Rate
Time Frame: Baseline up to 12 months
The percentage of subjects with a complete response, partial response, or stable disease as determined by RECIST 1.1.
Baseline up to 12 months
Clinical Benefit Rate
Time Frame: From the first dose to complete response, partial response, or stable disease for ≥24 weeks
The percentage of subjects with a complete response, partial response, or stable disease for ≥24 weeks as determined by RECIST 1.1.
From the first dose to complete response, partial response, or stable disease for ≥24 weeks
Overall Survival
Time Frame: Baseline up to 24 months
The time from the start of initial treatment to death from any cause
Baseline up to 24 months
Adverse event (AE)
Time Frame: From the subject's signing of the informed consent form to 28 days after the last dose or the start of new anti-tumor therapy (whichever occurs first)
Incidence and severity of adverse events
From the subject's signing of the informed consent form to 28 days after the last dose or the start of new anti-tumor therapy (whichever occurs first)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 20, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TQB3616-II-04

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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