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

NCT ID: NCT06851442

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-16
• Study Completion Date: 2025-11-20

Brief 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 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

TQB3912 tablets in combination with fulvestrant injection± TQB3616 capsules

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Fuzhou First General Hospital

Fuzhou, Fujian, China

Quanzhou First Hospital

Quanzhou, Fujian, China

Meizhou peoples Hospital

Meizhou, Guangdong, China

Guizhou Medical University Affiliated Cancer Hospital Co., Ltd

Guiyang, Guizhou, China

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Harbin Medical University Cancer

Harbin, Heilongjiang, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Yongzhou Central Hospital

Yongzhou, Hunan, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, China

Xinjiang Medical University Affiliated Cancer Hospital

Ürümqi, Xinjiang, China

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, China

Taizhou Central Hospital (Taizhou University Affiliated Hospital)

Taizhou, Zhejiang, China

Countries

China

Other Identifiers

TQB3912-TQB3616-Ib/II-01

Identifier Type: -

Identifier Source: org_study_id