- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05375461
TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail
A Phase III,Randomized, Double-blind, Paralle, Multi-center Study to Evaluate the Efficacy and Safety of TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Participants With Hormone Receptor (HR)-Positive, Human Epidermal Growth Factor Receptor(EGFR) 2-Negative Advanced Breast Cancer
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Yongmei Yin
- Phone Number: 13951842727
- Email: ym.yin@hotmail.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100039
- Recruiting
- The Fifth Medical Center of PLA General Hospital
-
Contact:
- Zefei Jiang
- Phone Number: 01066947171
- Email: jiangzefei@csco.org.cn
-
Beijing, Beijing, China, 100142
- Recruiting
- Beijing Cancer Hosptital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- Has had other malignant tumors within 3 years or currently has other malignant tumors;
- Have a variety of factors that affect oral medication (such as inability to swallow, chronic diarrhea, and intestinal obstruction);
- Unmitigated toxicity above CTCAE1 grade due to any prior treatment;
- Severe infections (≥CTCAE2 grade) that were active or uncontrolled before the study treatment started;
- Cirrhosis, active hepatitis;
- 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:
- Clinical evidence or history of central nervous system metastases (CNS) and/or cancerous meningitis or pneumomeningeal disease;
- 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);
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: TQB3616 capsules plus fulvestrant
The dose of TQB3616 capsules is 180mg, taken orally on an empty stomach, once a day for 28 consecutive days as one treatment cycle. 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. |
The dose of TQB3616 capsules is 180mg, taken orally on an empty stomach, once a day for 28 consecutive days as one treatment cycle.
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.
|
PLACEBO_COMPARATOR: TQB3616-matching placebo plus fulvestrant
The dose of placebo is 180mg, taken orally on an empty stomach, once a day for 28 consecutive days as one treatment cycle. 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. |
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.
The dose of placebo is 180mg, taken orally on an empty stomach, once a day for 28 consecutive days as one treatment cycle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS)
Time Frame: Baseline up to 24 months
|
Progression-free survival (First-time progression of disease/ recurrence /death)
|
Baseline up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression-free survival (PFS) by Independent Review Committee
Time Frame: Baseline up to 24 months
|
Progression-free survival(First-time progression of disease/ recurrence /death)
|
Baseline up to 24 months
|
Overall survival (OS)
Time Frame: Baseline up to 24 months
|
Overall survival (Baseline up to death)
|
Baseline up to 24 months
|
Clinical benefit rate (CBR)
Time Frame: 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)
|
Baseline up to 24 months
|
Duration of Response (DOR)
Time Frame: Baseline up to 24 months
|
Duration of Response(Baseline up to progression of disease/ recurrence /death)
|
Baseline up to 24 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TQB3616-III-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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