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

Plain English Summary

TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail is a Phase 3 clinical trial sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. studying HR-positive,HER2-negative in Advanced Breast Cancer. This trial tests if TQB3616 capsules, when given with fulvestrant, are better than a placebo with fulvestrant for advanced breast cancer. It is for women with hormone receptor-positive, HER2-negative advanced breast cancer who have had prior treatment. Participants will receive either TQB3616 capsules plus fulvestrant or a placebo plus fulvestrant. Alternative treatments for this type of breast cancer include other hormone therapies, chemotherapy, and targeted therapies. The trial aims to enroll 293 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Women aged 18-75 with a specific type of advanced breast cancer (HR-positive, HER2-negative) that has progressed after prior treatment. Patients must have at least one measurable tumor and good general health, including adequate organ function. Individuals with brain metastases, recent chemotherapy or radiation, or other active cancers may not be eligible. This trial is studying HR-positive,HER2-negative in Advanced Breast Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome, Progression-Free Survival (PFS), measures how long patients live without their cancer getting worse, indicating how well the new drug combination controls the disease. The specific primary outcome measures are: Progression-free survival (PFS) (Baseline up to 24 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a need for more effective treatments for advanced HR-positive, HER2-negative breast cancer, aiming to improve outcomes for patients who have already undergone some therapy. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets HR-positive,HER2-negative in Advanced Breast Cancer, where improved treatment options are needed.

Investor Insight

This trial signals potential for a new treatment option in the large breast cancer market, with TQB3616 aiming to compete with existing therapies for HR+/HER2- advanced disease. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor about the potential benefits and risks of TQB3616 and fulvestrant, and how this trial compares to other treatment options. Participation involves taking study medication (TQB3616 capsules or placebo) daily and receiving fulvestrant injections regularly. Regular clinic visits will be required for check-ups, tests, and monitoring of your health and cancer progression. The trial is being conducted at 2 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 293 participants

Interventions

• DRUG: TQB3616 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.
• DRUG: TQB3616-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.
• DRUG: Fluvestrin 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.

Primary Outcomes

• Progression-free survival (PFS) (Baseline up to 24 months)

Secondary Outcomes

• Progression-free survival (PFS) by Independent Review Committee (Baseline up to 24 months)
• Overall survival (OS) (Baseline up to 24 months)
• Clinical benefit rate (CBR) (Baseline up to 24 months)
• Duration of Response (DOR) (Baseline up to 24 months)

Full Eligibility Criteria

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.

Trial Locations

• The Fifth Medical Center of PLA General Hospital, Beijing, Beijing Municipality, China
• Beijing Cancer Hosptital, Beijing, Beijing Municipality, China

Frequently Asked Questions

Related Conditions

• Advanced Breast Cancer
• Hormone Receptor-Positive Breast Cancer
• HER2-Negative Breast Cancer
• Metastatic Breast Cancer
• Endocrine Therapy Resistance
• Estrogen Receptor-Positive Cancer
• Postmenopausal Breast Cancer
• Recurrent Breast Cancer
• Solid Tumors
• Oncology

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