HR-positive,HER2-negative in Advanced Breast Cancer
Conditions
Brief summary
This is a Phase III, a randomized, double-blind, parallel , multi-center trail to evaluate the efficacy and safety of TQB3616 capsules plus fulvestrant compared to placebo plus fulvestrant in participants with estrogen receptor-positive, HER2-Negative Advanced Breast Cancer. Approximately 287 women will be randomized to either TQB3616 plus fulvestrant or TQB3616-matching placebo plus fulvestrant. Randomization will follow a 2:1 randomization ratio,the experimental is 191; the Placebo Comparator is 96.
Interventions
DRUGTQB3616 capsules
The dose of TQB3616 capsules is 180mg, taken orally on an empty stomach, once a day for 28 consecutive days as one treatment cycle.
DRUGTQB3616-matching placebo
The dose of placebo is 180mg, taken orally on an empty stomach, once a day for 28 consecutive days as one treatment cycle.
DRUGFluvestrin injection
Fluvestrin injection was given at a fixed dose of 500mg on day 1, day 15 of the first treatment cycle and day 1 of each subsequent treatment cycle, and a treatment cycle of 28 days.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 1 The subjects voluntarily joined the study and signed the informed consent, with good compliance. * 2 Age: 18-75 years old (upon signing the informed consent);ECOG PS score: 0\ 1; Expected survival ≥3 months. * 3 participants with estrogen receptor-positive, HER2-Negative Advanced Breast Cancer were identified by pathological testing. * 4 Patients at the relapse/metastatic stage were allowed to receive no more than 1 line of rescue chemotherapy or rescue endocrine therapy. * 5 Confirmation of at least one measurable lesion according to RECIST1.1 criteria. * 6 The main organs are functioning well and meet the following criteria: Routine blood examination criteria (no blood transfusion or hematopoietic stimulus drug correction within 7 days before screening) : a) hemoglobin (Hb) ≥100g/L; b) neutrophils absolute value (NEUT) ≥1.5×10\^9/L; c) Platelet count (PLT) ≥90×10\^9/L. Biochemical tests should meet the following criteria: a) Total bilirubin (TBIL) ≤2.5 times the upper limit of normal (ULN); b) Alanine transferase (ALT) and aspartate transferase (AST) ≤2.5×ULN.ALT and AST≤5×ULN with liver metastasis. c) Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance rate (CCR) ≥60ml/min. The blood coagulation function test should meet the following criteria: prothrombin time (PT), activated partial thromboplastin time (APTT), international standardized ratio (INR) ≤1.5×ULN (no anticoagulant therapy); Cardiac ultrasound evaluation: left ventricular ejection fraction (LVEF)≥50%.
Exclusion criteria
* 1 Complicated diseases and medical history: 1. Has had other malignant tumors within 3 years or currently has other malignant tumors; 2. Have a variety of factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction); 3. Unmitigated toxicity above CTCAE1 grade due to any prior treatment; 4. Severe infections (≥CTCAE2 grade) that were active or uncontrolled before the study treatment started; 5. Cirrhosis, active hepatitis； 6. Have a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; * 2 Tumor-related symptoms and treatment: 1. Clinical evidence or history of central nervous system metastases (CNS) and/or cancerous meningitis or pneumomeningeal disease; 2. Had received chemotherapy within 3 weeks prior to the start of study treatment, and had received radiotherapy (except palliative radiotherapy for non-target lesions), hormone therapy, or other anti-tumor therapy within 2 weeks prior to the start of study treatment (washout period was calculated from the end of last treatment); 3. Uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage (as determined by the investigator). * 3 Known to be allergic to fluvestone, TQB3616 or any excipient. * 4 Participated in clinical trials of other antitumor drugs within 4 weeks prior to the initiation of study therapy. * 5 Has other conditions that make it inappropriate for the patient to be enrolled based on investigator's opinion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Baseline up to 24 months | Progression-free survival (First-time progression of disease/ recurrence /death) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) by Independent Review Committee | Baseline up to 24 months | Progression-free survival（First-time progression of disease/ recurrence /death） |
| Overall survival (OS) | Baseline up to 24 months | Overall survival (Baseline up to death) |
| Clinical benefit rate (CBR) | Baseline up to 24 months | Percentage of subjects with complete (CR) or partial response (PR) or stable disease (SD)（ Baseline up to progression of disease/ recurrence /death） |
| Duration of Response (DOR) | Baseline up to 24 months | Duration of Response(Baseline up to progression of disease/ recurrence /death) |
Countries
China
Outcome results
None listed