Evaluation of the Efficacy and Safety of TQB3616 Capsules Combined With Hormonal Therapy in a Phase II Clinical Trial for Cyclin-dependent Kinases 4 and 6（CDK4/6)Inhibitor-Resistant, Hormone Receptor(HR)-Positive, Human Epidermal Growth Factor Receptor 2(HER2)-Negative Recurrent/Metastatic Breast Cancer

Plain English Summary

Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer is a Phase 2 clinical trial sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. studying Breast Cancer. This trial tests a new drug, TQB3616, combined with hormonal therapy. It is for women with advanced (recurrent/metastatic) breast cancer that no longer responds to CDK4/6 inhibitors. Participants will receive TQB3616 capsules and Fulvestrant injection. Standard treatment options for this specific situation may be limited, making this trial an important alternative. The trial aims to enroll 33 participants.

Official Summary

Evaluation of the Efficacy and Safety of TQB3616 Capsules Combined with Hormonal Therapy in a Phase II Clinical Trial for Cyclin-dependent Kinases 4 and 6 (CDK4/6) Inhibitor-Resistant, HR-Positive, HER2-Negative Recurrent/Metastatic Breast Cancer.

Who Can Participate

Here is what you need to know about eligibility for this trial. Women aged 18-75 with a specific type of breast cancer that has spread and is resistant to certain prior treatments. Patients must have at least one measurable tumor and be in good general health. Women of childbearing potential must agree to use contraception. Cannot join if you have a history of HER2-positive breast cancer, other recent cancers, or certain serious medical conditions like heart or lung problems. This trial is studying Breast Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The main goal is to see how many patients respond to the combination treatment, meaning their tumors shrink or stop growing, which indicates the treatment is working. The specific primary outcome measures are: Objective Response Rate (Baseline up to 12 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 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a critical need for new treatments in patients with breast cancer that has become resistant to common therapies, aiming to improve outcomes where options are currently limited. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Breast Cancer, where improved treatment options are needed.

Investor Insight

This trial targets a significant unmet need in a large patient population, with TQB3616 representing a potential new therapeutic option in a competitive but growing market for advanced breast cancer t Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the potential benefits and risks of TQB3616 and Fulvestrant. Understand how often you will need to visit the clinic for check-ups and treatment. Be prepared for potential side effects and how they will be managed. The trial is being conducted at 13 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: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 33 participants

Interventions

• DRUG: TQB3616 capsule+Fulvestrant Injection — TQB3616 capsule is a CDK2/4/6 inhibitor and Fulvestrant injection is an anti-estrogen medication, and its pharmacological mechanism mainly exerts its therapeutic effect by inhibiting the action of aromatase.

Primary Outcomes

• Objective Response Rate (Baseline up to 12 months)

Secondary Outcomes

• Progression Free Survival (Baseline up to 12 months)
• Duration of Response (Baseline up to 12 months)
• Disease Control Rate (Baseline up to 12 months)
• Clinical Benefit Rate (From the first dose to complete response, partial response, or stable disease for ≥24 weeks)
• Overall Survival (Baseline up to 24 months)

Full Eligibility Criteria

Inclusion Criteria:

* Subjects voluntarily join the study, sign the informed consent form, and have good compliance
* Aged 18 to 75 years, with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0\~1; expected survival time of more than 3 months.
* Postmenopausal or premenopausal/perimenopausal female patients
* Progressed after prior treatment with CDK4/6 inhibitors
* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
* Good major organ function
* Women of childbearing potential must agree to use contraception during the study and for 6 months after its completion.

Exclusion Criteria:

* Subjects with a previous pathological diagnosis of HER2-positive breast cancer.
* Subjects with inflammatory breast cancer or occult breast cancer.
* Subjects who have had or currently have other malignant tumors within 5 years prior to randomization.
* Subjects with unresolved toxicity (greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1) from prior treatment, excluding alopecia.
* Subjects who have undergone major surgical procedures, incisional biopsies, or significant traumatic injuries within 28 days prior to the first dose.
* Subjects with non-tumor-related unresolved wounds, ulcers, or fractures.
* Subjects with multiple factors affecting oral medication intake and absorption.
* Subjects with arterial or deep vein thrombotic events within 6 months prior to the first dose.
* Subjects with ≥ Grade 2 myocardial ischemia or myocardial infarction, arrhythmia, angina requiring anti-anginal medication, clinically significant valvular heart disease, or uncontrolled hypertension.
* Subjects with a history of interstitial lung disease/pneumonitis (non-infectious) requiring steroid intervention or currently having interstitial lung disease/pneumonitis, or subjects with suspected interstitial lung disease/pneumonitis on screening imaging that cannot be excluded.
* Subjects with active or uncontrolled serious infections (≥CTCAE Grade 2 infection) or unexplained fever \>38.5°C within 28 days prior to the first dose.
* Subjects with a history of abuse of psychotropic drugs that cannot be abstained from or those with psychiatric disorders.
* Subjects with (pseudo) cirrhosis, active hepatitis.
* Subjects with renal failure requiring hemodialysis or peritoneal dialysis.
* Subjects with a history of immunodeficiency diseases, organ transplants, or hematopoietic stem cell transplants.
* Subjects who have previously received fulvestrant or other oral Selective Estrogen Receptor Degrader (SERD) class drugs.
* Subjects who have previously received anti-HER2 therapy.
* Subjects who have previously received antibody-drug conjugate therapy.
* Subjects who have participated in other anti-tumor clinical trials and taken investigational drugs within 4 weeks prior to the first dose.
* Subjects judged by the investigator to have serious accompanying diseases that severely endanger the safety of the subject or affect the completion of the study, or subjects who are deemed unsuitable for enrollment for other reasons

Trial Locations

• The First Affilliated Hospital of Bengbu Medical University, Bengbu, Anhui, China
• Jiangmen Central Hospital, Jiangmen, Guangdong, China
• Xingtai People's Hospital, Xingtai, Hebei, China
• Harbin Medical University Cancer Hostipal, Harbin, Heilongjiang, China
• Luohe Central Hospital, Luohe, Henan, China
• Hunan Cancer Hospital, Changsha, Hunan, China
• Jiangsu Provincial People's Hospital, Nanjing, Jiangsu, China
• Hai'an People's Hospital, Nantong, Jiangsu, China
• Liaoning Cancer Hospital, Shenyang, Liaoning, China
• Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital), Jinan, Shandong, China
• ...and 3 more locations

Frequently Asked Questions

Related Conditions

• Breast Cancer
• Hormone Receptor-Positive Breast Cancer
• HER2-Negative Breast Cancer
• Metastatic Breast Cancer
• Recurrent Breast Cancer
• CDK4/6 Inhibitor Resistance
• Endocrine Therapy Resistance
• Advanced Breast Cancer
• Solid Tumors
• Oncology

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