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

NCT06702618 | Active Not Recruiting Phase 2

• 1 other identifier: TQB3616-II-04
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 13

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  The proportion of patients achieving complete response and partial response among the total evaluable cases.

  Baseline up to 12 months

Secondary Outcomes (6)

• 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

Study Arms (1)

TQB3616 capsule+Fulvestrant Injection

EXPERIMENTAL

Drug: TQB3616 capsule+Fulvestrant Injection

Interventions

TQB3616 capsule+Fulvestrant Injection DRUG

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.

TQB3616 capsule+Fulvestrant Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (13)

The First Affilliated Hospital of Bengbu Medical University

Bengbu, Anhui, 233000, China

Location

Jiangmen Central Hospital

Jiangmen, Guangdong, 529000, China

Location

Xingtai People's Hospital

Xingtai, Hebei, 54000, China

Location

Harbin Medical University Cancer Hostipal

Harbin, Heilongjiang, 150000, China

Location

Luohe Central Hospital

Luohe, Henan, 462000, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410010, China

Location

Jiangsu Provincial People's Hospital

Nanjing, Jiangsu, 210003, China

Location

Hai'an People's Hospital

Nantong, Jiangsu, 226600, China

Location

Liaoning Cancer Hospital

Shenyang, Liaoning, 110000, China

Location

Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)

Jinan, Shandong, 250117, China

Location

The First Affiliated Hospital of Xi'an Jiao Tong University

Xi’an, Shanxi, 710061, China

Location

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 646000, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, Tianjin Municipality, 300202, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2024
• First Posted: November 25, 2024
• Study Start: February 20, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Locations

CN (13)