Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: TQB3616 capsule+Fulvestrant Injection

• Study Type: Interventional
• Enrollment (Estimated): 33
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233000
      • The First Affilliated Hospital of Bengbu Medical University
  • Guangdong
    • Jiangmen, Guangdong, China, 529000
      • Jiangmen Central Hospital
  • Hebei
    • Xingtai, Hebei, China, 54000
      • Xingtai People's Hospital
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Harbin Medical University Cancer Hostipal
  • Henan
    • Luohe, Henan, China, 462000
      • Luohe Central Hospital
  • Hunan
    • Changsha, Hunan, China, 410010
      • Hunan Cancer Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210003
      • Jiangsu Provincial People's Hospital
    • Nantong, Jiangsu, China, 226600
      • Hai'an People's Hospital
  • Liaoning
    • Shenyang, Liaoning, China, 110000
      • Liaoning Cancer Hospital
  • Shandong
    • Jinan, Shandong, China, 250117
      • Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)
  • Shanxi
    • Xi’an, Shanxi, China, 710061
      • The First Affiliated Hospital of Xi'an Jiao Tong University
  • Sichuan
    • Luzhou, Sichuan, China, 646000
      • The affiliated hospital of Southwest Medical University
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300202
      • Tianjin Medical University Cancer Institute & Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TQB3616 capsule+Fulvestrant Injection	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate	The proportion of patients achieving complete response and partial response among the total evaluable cases.	Baseline up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression Free Survival	Progression Free Survival (PFS) is defined as the length of time from the start of treatment until the disease progresses or the patient dies from any cause.	Baseline up to 12 months
Duration of Response	The time from the first assessment of the tumor as a complete response or partial response to the first occurrence of disease progression or death from any cause.	Baseline up to 12 months
Disease Control Rate	The percentage of subjects with a complete response, partial response, or stable disease as determined by RECIST 1.1.	Baseline up to 12 months
Clinical Benefit Rate	The percentage of subjects with a complete response, partial response, or stable disease for ≥24 weeks as determined by RECIST 1.1.	From the first dose to complete response, partial response, or stable disease for ≥24 weeks
Overall Survival	The time from the start of initial treatment to death from any cause	Baseline up to 24 months
Adverse event (AE)	Incidence and severity of adverse events	From the subject's signing of the informed consent form to 28 days after the last dose or the start of new anti-tumor therapy (whichever occurs first)

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: November 20, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Actual): November 25, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Antineoplastic Agents; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Estrogen Receptor Antagonists; Estrogen Antagonists; Fulvestrant
• Other Study ID Numbers: TQB3616-II-04

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No