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

NCT06851442 | Terminated Phase 1

• 1 other identifier: TQB3912-TQB3616-Ib/II-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 17

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

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose (MTD)

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

  4 months after Queue 2 begins enrollment

• phase II recommended dose (RP2D)

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

  4 months after Queue 2 begins enrollment

• Objective Remission Rate (ORR)

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

  8 to 16 weeks after enrollment

Secondary Outcomes (10)

• Progression-free survival (PFS)

  From enrollment to disease progression, an average of 14 months

• Duration of response (DOR)

  From enrollment to disease progression, an average of 14 months

• Disease control rate (DCR)

  8 to 16 weeks after enrollment

• Clinical benefit ratio (CBR)

  ≥24 weeks after enrollment

• Overall survival (OS)

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

Study Arms (1)

TQB3912 tablets in combination with fulvestrant injection± TQB3616 capsules

EXPERIMENTAL

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

Interventions

TQB3912 tablets in combination with fulvestrant injection± TQB3616 capsules DRUG

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

TQB3912 tablets in combination with fulvestrant injection± TQB3616 capsules

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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

Sponsors & Collaborators

• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: lead

Study Sites (17)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233000, China

Location

Fuzhou First General Hospital

Fuzhou, Fujian, 350009, China

Location

Quanzhou First Hospital

Quanzhou, Fujian, 362000, China

Location

Meizhou peoples Hospital

Meizhou, Guangdong, 514000, China

Location

Guizhou Medical University Affiliated Cancer Hospital Co., Ltd

Guiyang, Guizhou, 550001, China

Location

Guizhou Provincial People's Hospital

Guiyang, Guizhou, 550002, China

Location

Harbin Medical University Cancer

Harbin, Heilongjiang, 150000, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

Yongzhou Central Hospital

Yongzhou, Hunan, 425002, China

Location

Liaoning Cancer Hospital

Shenyang, Liaoning, 110000, China

Location

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, Shaanxi, 710061, China

Location

Shanxi Cancer Hospital

Taiyuan, Shanxi, 030000, China

Location

Tianjin Cancer Hospital Airport Hospital

Tianjin, Tianjin Municipality, 300202, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300202, China

Location

Xinjiang Medical University Affiliated Cancer Hospital

Ürümqi, Xinjiang, 830000, China

Location

Ningbo Medical Center Lihuili Hospital

Ningbo, Zhejiang, 315000, China

Location

Taizhou Central Hospital (Taizhou University Affiliated Hospital)

Taizhou, Zhejiang, 31800, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2025
• First Posted: February 28, 2025
• Study Start: May 16, 2025
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: December 12, 2025

Record last verified: 2024-12

Locations

CN (17)