Clinical trial NCT05780567: Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-22
Enrollment: 1946
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase III, randomized, double-blind, parallel, multi-center trail to evaluate the efficacy and safety of TQB3616 capsule combined with endocrine compared to placebo compared with endocrine in HR-positive and HER2-negative breast cancer adjuvant therapy. Approximately 1946 female subjects will be randomized to either TQB3616 combined with endocrine group or TQB3616-matching placebo combined endocrine group. Randomization will follow a 2:1 ratio, 1297 subjects in experimental group and 649 in the the Placebo Comparator group.


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.

Primary outcomes:
measure: Invasive Disease-Free Survival (IDFS)
timeFrame: Baseline up to 60 months
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: Baseline up to 60 months
measure: Disease Relapse Free Survival (DRFS)
timeFrame: Baseline up to 60 months
measure: Incidence of adverse events
timeFrame: Baseline up to 60 months
measure: Severity of adverse events
timeFrame: Baseline up to 60 months
measure: Incidence of abnormal laboratory test values
timeFrame: Baseline up to 60 months
measure: Severity of abnormal laboratory test values
timeFrame: Baseline up to 60 months
measure: Incidence of serious adverse events
timeFrame: Baseline up to 60 months
measure: Severity of serious adverse events
timeFrame: Baseline up to 60 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Science
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
state: Guangdong
city: Suining
country: China
facility: Suining Central Hospital
state: Sichuan
Study officials:
References: