Evaluating a new treatment for advanced hormone receptor-positive breast cancer

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 study is testing a new treatment combining TQB3912 tablets and fulvestrant injections to see if it helps people with advanced hormone receptor-positive breast cancer feel better and live longer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Locations: 17 sites (Bengbu, Anhui and 16 other locations)
• Trial ID: NCT06851442 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of TQB3912 tablets combined with fulvestrant injection and optionally TQB3616 capsules in patients with locally advanced or metastatic hormone receptor-positive and HER2-negative breast cancer. The study aims to determine the maximum tolerated dose and the recommended phase II dose while assessing various efficacy endpoints such as overall response rate and progression-free survival. Participants will be monitored for safety and pharmacokinetic characteristics throughout the trial.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-75 with locally advanced or metastatic hormone receptor-positive and HER2-negative breast cancer who have progressed after prior endocrine therapy.

Not a fit: Patients with early-stage breast cancer or those who have not received prior endocrine therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced hormone receptor-positive breast cancer.

How similar studies have performed: Other studies have shown promise in using combination therapies for similar breast cancer types, indicating potential for success in this approach.

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.

Where this trial is running

Bengbu, Anhui and 16 other locations

• The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui, China (Not_yet_recruiting)
• Fuzhou First General Hospital — Fuzhou, Fujian, China (Not_yet_recruiting)
• Quanzhou First Hospital — Quanzhou, Fujian, China (Not_yet_recruiting)
• Meizhou peoples Hospital — Meizhou, Guangdong, China (Not_yet_recruiting)
• Guizhou Medical University Affiliated Cancer Hospital Co., Ltd — Guiyang, Guizhou, China (Not_yet_recruiting)
• Guizhou Provincial People's Hospital — Guiyang, Guizhou, China (Not_yet_recruiting)
• Harbin Medical University Cancer — Harbin, Heilongjiang, China (Recruiting)
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China (Not_yet_recruiting)
• Yongzhou Central Hospital — Yongzhou, Hunan, China (Not_yet_recruiting)
• Liaoning Cancer Hospital — Shenyang, Liaoning, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xi'an Jiao Tong University — Xi'an, Shaanxi, China (Not_yet_recruiting)
• Shanxi Cancer Hospital — Taiyuan, Shanxi, China (Not_yet_recruiting)
• Tianjin Cancer Hospital Airport Hospital — Tianjin, Tianjin, China (Not_yet_recruiting)
• Tianjin Medical University Cancer Institute & Hospital — Tianjin, Tianjin, China (Not_yet_recruiting)
• Xinjiang Medical University Affiliated Cancer Hospital — Ürümqi, Xinjiang, China (Not_yet_recruiting)
• Ningbo Medical Center Lihuili Hospital — Ningbo, Zhejiang, China (Not_yet_recruiting)
• Taizhou Central Hospital (Taizhou University Affiliated Hospital) — Taizhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Quchang Ouyang, Doctor

Conditions Breast Cancer