Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer

Phase 3

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: TQB3616 capsules, Letrozole, Anastrozole, Tamoxifen; Drug: Placebo capsules, Letrozole, Anastrozole, Tamoxifen

• Registration Number: NCT05780567
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2023-03-10
• Study First Submitted QC: 2023-03-10
• Study First Posted: 2023-03-22
• Study Start: 2023-03-30
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-21
• Primary Completion: 2026-12
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1946

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TQB3616 capsules combined with endocrine	TQB3616 capsules, Letrozole, Anastrozole, Tamoxifen	The dose of TQB3616 capsules is 180mg, taken orally when fasting, once a day for 28 consecutive days as one treatment cycle. The dose of Letrozole is 2.5mg, taken orally, once a day for 28 consecutive days as one treatment cycle. The dose of Anastrozole is 1mg, taken orally, once a day for 28 consecutive days as one treatment cycle. The dose of Tamoxifen is 10mg, taken orally, twice a day for 28 consecutive days as one treatment cycle.
placebo combined with endocrine	Placebo capsules, Letrozole, Anastrozole, Tamoxifen	The dose of placebo is 180mg, taken orally when fasting, once a day for 28 consecutive days as one treatment cycle. The dose of Letrozole is 2.5mg, taken orally, once a day for 28 consecutive days as one treatment cycle. The dose of Anastrozole is 1mg, taken orally, once a day for 28 consecutive days as one treatment cycle. The dose of Tamoxifen is 10mg, taken orally, twice a day for 28 consecutive days as one treatment cycle.

Primary Outcome Measures

Name	Time	Method
Invasive Disease-Free Survival (IDFS)	Baseline up to 60 months	The time from the date of randomization to the first occurrence of the following events, including ipsilateral or contralateral recurrence of invasive breast cancer, regional or distant recurrence of invasive breast cancer, secondary primary malignancy outside the breast, and death from any cause.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	Baseline up to 60 months	The time from first administration to death of any cause.
Incidence of adverse events	Baseline up to 60 months	Incidence of adverse events assessed according to the common terminology criteria for adverse events (CTCAE).
Severity of adverse events	Baseline up to 60 months	Severity of adverse events assessed according to the common terminology criteria for adverse events (CTCAE).
Incidence of abnormal laboratory test values	Baseline up to 60 months	Incidence of abnormal laboratory test values assessed according to the common terminology criteria for adverse events (CTCAE).
Severity of abnormal laboratory test values	Baseline up to 60 months	Severity of abnormal laboratory test values assessed according to the common terminology criteria for adverse events (CTCAE).
Incidence of serious adverse events	Baseline up to 60 months	Incidence of serious adverse events assessed according to the common terminology criteria for adverse events (CTCAE).
Severity of serious adverse events	Baseline up to 60 months	Severity of serious adverse events assessed according to the common terminology criteria for adverse events (CTCAE).
Disease Relapse Free Survival (DRFS)	Baseline up to 60 months	The time from the date of randomization to the first occurrence of distant recurrence or death from any cause.

Trial Locations

Locations (3)

Cancer Hospital Chinese Academy of Medical Science; 🇨🇳 Beijing, Beijing, China

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

Suining Central Hospital; 🇨🇳 Suining, Sichuan, China