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Breast CancerPhase 1/2NCT06851442

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

A Phase 1/2 study testing TQB3912 tablets in combination with fulvestrant injection± TQB3616 capsules in people with Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 17 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Breast Cancer
What is being tested?
TQB3912 tablets in combination with fulvestrant injection± TQB3616 capsules
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
17 sitesChina
Study dates
16 May 2025to 20 Nov 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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.

Who cannot join

  • 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:
  • Have appeared within 3 years or have also suffered from other malignant tumors;
  • Adverse reactions from previous treatments have not been restored to CTCAE 5.0 grade≤1;
  • It affects oral and drug absorption
  • 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;
Show all 35Show fewer
  • Congenital bleeding , coagulation dysfunction disease;
  • Arterial/deep thrombosis events occurred;
  • Blood pressure control was not ideal;
  • Major cardiovascular disease;
  • Uncontrolled ≥CTCAE level 2 within 14 days before the start of study treatment
  • A history of active tuberculosis, pulmonary fibrosis or pneumonia;
  • a past or currently associated with interstitial lung disease/pneumonia;
  • active viral hepatitis and poor control;
  • treatment is required
  • uncontrollable kidney disease;
  • a history of immunodeficiency;
  • a person who is prepared to undergo or has undergone genealogical bone marrow transplants or solid organ transplants;
  • uncontrollable diabetes;
  • a person who suffers from People with epilepsy and need treatment;
  • People with a history of psychotropic substance abuse and cannot be abstained or have mental disorders.
  • Tumor-related symptoms and treatment:
  • If it is not controlled, the third gap effusion still needs to be repeatedly drained;
  • There is lung cancer pharyngitis;
  • During the study period, the tumor is very likely to invade important blood vessels and cause it Fatal severe bleeding;
  • Use strong CYP3A4 inhibitor or strong inducer, and the drug half-life is less than 3 before the start of the study treatment;
  • 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
  • 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:
  • Used phosphatidylinositol 3 kinase (PI3K)/AKT/mammalian target of rapamycin (mTOR) inhibitors;
  • Used fulvestrant or other selective estrogen receptor degrading agents (SERD);
  • Used in any study drug or drug Allergic to any ingredient or excipient;
  • a history of live attenuated vaccination within 28 days before the first medication or planned to undergo live attenuated vaccination during the study period;
  • 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.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

China17 sites

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233000

  • Fuzhou First General Hospital

    Fuzhou, Fujian, 350009

  • Guizhou Medical University Affiliated Cancer Hospital Co., Ltd

    Guiyang, Guizhou, 550001

  • Guizhou Provincial People's Hospital

    Guiyang, Guizhou, 550002

  • Harbin Medical University Cancer

    Harbin, Heilongjiang, 150000

  • Meizhou peoples Hospital

    Meizhou, Guangdong, 514000

  • Ningbo Medical Center Lihuili Hospital

    Ningbo, Zhejiang, 315000

  • Quanzhou First Hospital

    Quanzhou, Fujian, 362000

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, 110000

  • Shanxi Cancer Hospital

    Taiyuan, Shanxi, 030000

  • Taizhou Central Hospital (Taizhou University Affiliated Hospital)

    Taizhou, Zhejiang, 31800

  • Tianjin Cancer Hospital Airport Hospital

    Tianjin, Tianjin Municipality, 300202

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, Tianjin Municipality, 300202

  • Xinjiang Medical University Affiliated Cancer Hospital

    Ürümqi, Xinjiang, 830000

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 430071

  • The First Affiliated Hospital of Xi'an Jiao Tong University

    Xi'an, Shaanxi, 710061

  • Yongzhou Central Hospital

    Yongzhou, Hunan, 425002

Other trials in China

About this study

Official title: 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.

Conditions
Breast Cancer
Being tested
TQB3912 tablets in combination with fulvestrant injection± TQB3616 capsules
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TQB3912 tablets in combination with fulvestrant injection± TQB3616 capsulesDrug

    Protein kinase B(AKT) inhibitors+Cyclin-dependent kinase 4/6(CDK4/6) Inhibitor+Estrogen receptor antagonists.

Study groups in NCT06851442
Study groupRoleWhat they receive
TQB3912 tablets in combination with fulvestrant injection± TQB3616 capsulesExperimentalTQB3912 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.
Receives: Drug: TQB3912 tablets in combination with fulvestrant injection± TQB3616 capsules

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD)

    Phase Ib of Queue 2maximum tolerated dose (MTD, if any)

    Measured: 4 months after Queue 2 begins enrollment

  2. phase II recommended dose (RP2D)

    Phase II Queue 2: phase II recommended dose (RP2D).

    Measured: 4 months after Queue 2 begins enrollment

  3. Objective Remission Rate (ORR)

    Cohort 1, Phase II of Cohort 2: Objective Remission Rate (ORR).

    Measured: 8 to 16 weeks after enrollment

Secondary outcomes (10)

  1. Progression-free survival (PFS)

    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).

    Measured: From enrollment to disease progression, an average of 14 months

  2. Duration of response (DOR)

    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.

    Measured: From enrollment to disease progression, an average of 14 months

  3. Disease control rate (DCR)

    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.

    Measured: 8 to 16 weeks after enrollment

  4. Clinical benefit ratio (CBR)

    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.

    Measured: ≥24 weeks after enrollment

  5. Overall survival (OS)

    The time from randomization to death due to any cause.

    Measured: From enrollment to subject death, it is expected to be evaluated until 5 years

  6. Number of patients with adverse events (AEs) and serious adverse events (SAEs)

    Assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.

    Measured: Within 28 days after dosing

  7. Peak time (Tmax)

    Refers to the time after a single dose, the blood drug concentration reaches its peak.

    Measured: Within 24 hours after dosing

  8. Peak concentration (Cmax)

    Maximum plasma drug concentration.

    Measured: 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

  9. Elimination half life (t1/2)

    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.

    Measured: Within 1～7 days after dose

  10. Area under plasma concentration-time curve (AUC0-∞)

    The first dosing begins to extrapolate to an infinity plasma concentration-area under the time curve.

    Measured: Within 28 days after dosing

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2025
  2. Study start16 May 2025
  3. Primary completion20 Nov 2025
  4. Study completion20 Nov 2025

Why it stopped: This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06851442
Sponsor's protocol ID
TQB3912-TQB3616-Ib/II-01
Status last verified
Dec 2024
First submitted
22 Feb 2025
Last updated
12 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TQB3912 tablets in combination with fulvestrant injection± TQB3616 capsules in people with Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 17 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (time frame: 4 months after Queue 2 begins enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06851442.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.

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