Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced or Metastatic Hormone Receptor(HR)-Positive and Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Breast Cancer

December 5, 2025 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Phase Ib/II Clinical Trial to Evaluate the Efficacy and Safety of TQB3912 Tablets in Combination With Fulvestrant Injection± TQB3616 Capsules in Patients With Locally Advanced or Metastatic HR-positive and HER2-negative Breast Cancer.

This trial was designed to evaluate the maximum tolerated dose (MTD) and phase II recommended dose (RP2D) in subjects with TQB3912 tablets combined with fulvestrant injection and TQB3616 capsules for locally advanced or metastatic HR-positive and HER2-negative breast cancer.And the effectiveness of TQB3912 tablets combined with fulvestrant injection ±TQB3616 capsules in locally advanced or metastatic HR-positive and HER2-negative breast cancer subjects was evaluated by evaluating ORR, PFS, DOR, DCR, CBR, OS, etc., and at the same time, Assess its safety and pharmacokinetic (PK) characteristics.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

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 (Actual)

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.
8

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
  • Phase 1

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 Ouyang, Doctor
  • Phone Number: 0731-89762160
  • Email: oyqc1969@126.com

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233000
        • the First Affiliated Hospital of Bengbu Medical College
    • Fujian
      • Fuzhou, Fujian, China, 350009
        • Fuzhou First General Hospital
      • Quanzhou, Fujian, China, 362000
        • Quanzhou First Hospital
    • Guangdong
      • Meizhou, Guangdong, China, 514000
        • Meizhou peoples Hospital
    • Guizhou
      • Guiyang, Guizhou, China, 550002
        • Guizhou Provincial People's Hospital
      • Guiyang, Guizhou, China, 550001
        • Guizhou Medical University Affiliated Cancer Hospital Co., LTD
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • Harbin Medical University Cancer
    • Hubei
      • Wuhan, Hubei, China, 430071
        • Zhongnan Hospital of Wuhan University
    • Hunan
      • Yongzhou, Hunan, China, 425002
        • Yongzhou Central Hospital
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Liaoning Cancer Hospital
    • Shaanxi
      • Xi'an, Shaanxi, China, 710061
        • The First Affiliated Hospital of Xi'an Jiao Tong University
    • Shanxi
      • Taiyuan, Shanxi, China, 030000
        • Shanxi Cancer Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300202
        • Tianjin Cancer Hospital Airport Hospital
      • Tianjin, Tianjin Municipality, China, 300202
        • Tianjin Medical University Cancer Institute & Hospital
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Xinjiang Medical University Affiliated Cancer Hospital
    • Zhejiang
      • Ningbo, Zhejiang, China, 315000
        • Ningbo Medical Center Lihuili Hospital
      • Taizhou, Zhejiang, China, 31800
        • Taizhou Central Hospital (Taizhou University Affiliated 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:

  • The subjects voluntarily joined the study, signed an informed consent form, and had good compliance.
  • Age: 18-75 years old; Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score: 0~1 point; estimated survival time exceeds 3 months.
  • Women can be in the late period of menopause and before menopause/innerspring. If they are before menopause/siege period, they must continue to receive ovarian function inhibitory treatment during the research period to enter the group.
  • Anthropologically confirmed HR-positive and HER2-negative breast cancer.
  • Locally advanced or metastatic diseases that cannot undergo radical surgery.
  • Queue 1 Previous treatment requirements: progress after endocrine therapy; Queue 2 Previous treatment requirements: progress after endocrine therapy.
  • Have one or more phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA)/v-akt murine thymoma viral oncogene homolog 1 (AKT1)/phosphatase and tensin homolog deleted on chromosome ten (PTEN) gene mutations.
  • At least one measurable lesion exists according to the RECIST 1.1 standard.
  • Good function of the main organs
  • Female subjects of childbearing age should agree that contraceptive measures (such as Buds, contraceptives or condoms) must be used during the study period and within 6 months after the study ends; the serum pregnancy test is negative within 7 days before the study enrollment. , and must be non-lactation subjects; male subjects should agree to adopt contraceptive measures within 6 months after the end of the study period.

Exclusion Criteria:

  • It is known to suffer from spinal cord compression, cancerous meningitis, symptoms with brain metastasis or symptoms control for less than 4 weeks.

  • Combined diseases and medical history:

    1. Have appeared within 3 years or have also suffered from other malignant tumors;
    2. Adverse reactions from previous treatments have not been restored to CTCAE 5.0 grade≤1;
    3. It affects oral and drug absorption
    4. Those who have received major surgical treatment within 4 weeks before the first medication, obvious traumatic injury or expected to undergo major surgery during the study treatment, or have long-term uncured wounds or fractures;
    5. Congenital bleeding , coagulation dysfunction disease;
    6. Arterial/deep thrombosis events occurred;
    7. Blood pressure control was not ideal;
    8. Major cardiovascular disease;
    9. Uncontrolled ≥CTCAE level 2 within 14 days before the start of study treatment
    10. A history of active tuberculosis, pulmonary fibrosis or pneumonia;
    11. a past or currently associated with interstitial lung disease/pneumonia;
    12. active viral hepatitis and poor control;
    13. treatment is required
    14. uncontrollable kidney disease;
    15. a history of immunodeficiency;
    16. a person who is prepared to undergo or has undergone genealogical bone marrow transplants or solid organ transplants;
    17. uncontrollable diabetes;
    18. a person who suffers from People with epilepsy and need treatment;
    19. People with a history of psychotropic substance abuse and cannot be abstained or have mental disorders.

  • Tumor-related symptoms and treatment:

    1. If it is not controlled, the third gap effusion still needs to be repeatedly drained;
    2. There is lung cancer pharyngitis;
    3. During the study period, the tumor is very likely to invade important blood vessels and cause it Fatal severe bleeding;
    4. Use strong CYP3A4 inhibitor or strong inducer, and the drug half-life is less than 3 before the start of the study treatment;
    5. Have received anti-tumor treatment within 3 weeks before the start of the study treatment, and the washing is calculated from the end of the last treatment
    6. Within 2 weeks before the start of the study treatment, Chinese patent medicine treatment with anti-tumor indications was received in the National Medical Products Administration (NMPA) approved drug instructions.

  • Research and treatment related:

    1. Used phosphatidylinositol 3 kinase (PI3K)/AKT/mammalian target of rapamycin (mTOR) inhibitors;
    2. Used fulvestrant or other selective estrogen receptor degrading agents (SERD);
    3. Used in any study drug or drug Allergic to any ingredient or excipient;
    4. a history of live attenuated vaccination within 28 days before the first medication or planned to undergo live attenuated vaccination during the study period;
    5. is receiving systemic glucocorticoid therapy or any other form of immunosuppression therapy, and Continued use within 2 weeks before the start of the study treatment
  • According to the judgment of the researcher, there are situations that seriously endanger the safety of the subject or affect the subject's completion of the research.

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: TQB3912 tablets in combination with fulvestrant injection± TQB3616 capsules
TQB3912 tablets 120 mg quaque die (QD), + fulvestrant injection 500 mg quaque 4 week(Q4W) (C1D15),28 days as a treatment cycle. Or TQB3912 tablets 120 mg quaque die(QD)+TQB3616 capsules 80 mg/120 mg QD +fulvestrant injection 500 mg quaque 4 week(Q4W) (C1D15), 28 days as a treatment cycle.
Drug: TQB3912 tablets in combination with fulvestrant injection± TQB3616 capsules
Protein kinase B(AKT) inhibitors+Cyclin-dependent kinase 4/6(CDK4/6) Inhibitor+Estrogen receptor antagonists.

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
Maximum tolerated dose (MTD)
Time Frame: 4 months after Queue 2 begins enrollment
Phase Ib of Queue 2maximum tolerated dose (MTD, if any)
4 months after Queue 2 begins enrollment
phase II recommended dose (RP2D)
Time Frame: 4 months after Queue 2 begins enrollment
Phase II Queue 2: phase II recommended dose (RP2D).
4 months after Queue 2 begins enrollment
Objective Remission Rate (ORR)
Time Frame: 8 to 16 weeks after enrollment
Cohort 1, Phase II of Cohort 2: Objective Remission Rate (ORR).
8 to 16 weeks after enrollment

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 (PFS)
Time Frame: From enrollment to disease progression, an average of 14 months
Refers to the time from the beginning of the first treatment to the first progression of the disease or death for any cause (whichever occurs first).
From enrollment to disease progression, an average of 14 months
Duration of response (DOR)
Time Frame: From enrollment to disease progression, an average of 14 months
Patient from the date of first documentation of objective remission of the tumor to the date of first documentation of objective progression of the tumor or the date of death due to any cause.
From enrollment to disease progression, an average of 14 months
Disease control rate (DCR)
Time Frame: 8 to 16 weeks after enrollment
Proportion of participants with complete response, partial response, and stable disease as rated by RECIST v1.1 criteria for best overall efficacy after enrollment of all patients.
8 to 16 weeks after enrollment
Clinical benefit ratio (CBR)
Time Frame: ≥24 weeks after enrollment
Refers to the percentage of subjects with complete remission (CR), partial remission (PR), or stable disease (SD) determined by the investigator based on RECIST 1.1 for 24 weeks.
≥24 weeks after enrollment
Overall survival (OS)
Time Frame: From enrollment to subject death, it is expected to be evaluated until 5 years
The time from randomization to death due to any cause.
From enrollment to subject death, it is expected to be evaluated until 5 years
Number of patients with adverse events (AEs) and serious adverse events (SAEs)
Time Frame: Within 28 days after dosing
Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Within 28 days after dosing
Peak time (Tmax)
Time Frame: Within 24 hours after dosing
Refers to the time after a single dose, the blood drug concentration reaches its peak.
Within 24 hours after dosing
Peak concentration (Cmax)
Time Frame: 30 minuets pre-dose at cycle 1 day 1, 8 and day 28. 30 minuets,1, 2, 3, 4, 6, 8, 12, 24 hours after dose at cycle 1 day 1 and day 28. Each cycle is 28 days
Maximum plasma drug concentration.
30 minuets pre-dose at cycle 1 day 1, 8 and day 28. 30 minuets,1, 2, 3, 4, 6, 8, 12, 24 hours after dose at cycle 1 day 1 and day 28. Each cycle is 28 days
Elimination half life (t1/2)
Time Frame: Within 1～7 days after dose
The time it takes for the drug to eliminate half of the body, or the time it takes for the blood drug concentration to be reduced by half.
Within 1～7 days after dose
Area under plasma concentration-time curve (AUC0-∞)
Time Frame: Within 28 days after dosing
The first dosing begins to extrapolate to an infinity plasma concentration-area under the time curve.
Within 28 days after dosing

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.
May 16, 2025

Primary Completion (Actual)

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.
November 20, 2025

Study Completion (Actual)

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.
November 20, 2025

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).
February 22, 2025

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.
February 27, 2025

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.
February 28, 2025

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.
December 12, 2025

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.
December 5, 2025

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.
December 1, 2024

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.
  • TQB3912-TQB3616-Ib/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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings