Combining TQB3616 with endocrine therapy for breast cancer treatment

Randomized, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of TQB3616 Combined With Endocrine Therapy Versus Placebo Combined With Endocrine Therapy in Hormone Receptors (HR)-Positive and Human Epidermal GrowthFactor Receptor-2 (HER2) -Negative Breast Cancer Adjuvant Therapy

This study is testing if adding a new medication called TQB3616 to standard breast cancer treatment helps women with HR-positive and HER2-negative breast cancer do better than just using the standard treatment alone.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1946 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Locations: 3 sites (Beijing, Beijing and 2 other locations)
• Trial ID: NCT05780567 on ClinicalTrials.gov

What this trial studies

This Phase III clinical trial evaluates the efficacy and safety of TQB3616 capsules when combined with endocrine therapy compared to a placebo combined with endocrine therapy in patients with HR-positive and HER2-negative breast cancer. Approximately 1946 female participants will be randomly assigned to either the TQB3616 group or the placebo group in a 2:1 ratio. The study aims to determine if the addition of TQB3616 improves treatment outcomes in the adjuvant setting for breast cancer patients.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18-75 with HR-positive and HER2-negative invasive breast cancer who have undergone radical mastectomy.

Not a fit: Patients with other types of breast cancer or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective adjuvant therapy option for patients with HR-positive and HER2-negative breast cancer.

How similar studies have performed: Other studies have shown promise in combining targeted therapies with endocrine treatments, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

* The subjects voluntarily joined the study and signed the informed consent, with good compliance.
* Age: 18-75 years old (upon signing the informed consent); Eastern Cooperative Oncology Group Performance Status (PS) score: 0\~1;
* Surgical treatment of radical mastectomy;
* Pathological examination confirmed HR positive and HER2 negative invasive breast cancer;
* The major organs are functioning well, meeting the following criteria：

  1. Blood biochemical tests should meet the following criteria (no corrective therapy has been used within 7 days prior to screening)：

     1. Hemoglobin (HB) ≥90 g/L；
     2. Neutrophil absolute value (NEUT) ≥ 1.5×109/L；
     3. Platelet count (PLT) ≥ 100 ×109/L；
  2. Blood biochemical tests should meet the following criteria (no corrective therapy has been used within 7 days prior to screening)：

     1. Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN)；
     2. Alanine transferase (ALT) and aspartate transferase (AST) ≤ 1.5×ULN；
     3. Serum creatinine (Cr) ≤ 1.5×ULN, or creatinine clearance (Ccr) ≥ 60 ml/min；
  3. Blood clotting tests must meet the following criteria (no anticoagulant therapy)：

     1. Prothrombin time (PT) ≤ 1.5×ULN;
     2. Activated partial thromboplastin time (APTT) ≤ 1.5×ULN;
     3. International Normalized ratio (INR) ≤ 1.5×ULN.
  4. Left ventricular ejection fraction (LVEF) ≥50%.

Exclusion Criteria:

* Complicated diseases and medical history:

  1. Has had other malignant tumors within 5 years or currently has other malignant tumors;
  2. Have a variety of factors that affect oral medication (such as inability to swallow);
  3. Current history of serious lung disease such as interstitial pneumonia；
  4. Severe infections common terminology criteria for adverse events (≥CTCAE (common terminology criteria for adverse events) 2 grade) that were active or uncontrolled before the study treatment started (Except hair loss and hemoglobin)；
* Known allergy to aromatase inhibitors, tamoxifen, TQB3616/ placebo, or any excipients;
* There was a history of live attenuated vaccine vaccination within 28 days prior to randomization or live attenuated vaccine vaccination was planned during the study period;
* Participated in clinical trials of other antitumor agents within 4 weeks prior to randomization；
* The presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of study participation or interfere with the study results, as well as subjects who are deemed unsuitable for study participation for other reasons by the investigator.

Where this trial is running

Beijing, Beijing and 2 other locations

• Cancer Hospital Chinese Academy of Medical Science — Beijing, Beijing, China (Recruiting)
• Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Suining Central Hospital — Suining, Sichuan, China (Recruiting)

Conditions Breast Cancer