Clinical trial NCT06702618: Evaluation of TQB3616 Capsules in a Phase II Clinical Trial for Recurrent/Metastatic Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-25
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Objective Response Rate
timeFrame: Baseline up to 12 months
Secondary outcomes:
measure: Progression Free Survival
timeFrame: Baseline up to 12 months
measure: Duration of Response
timeFrame: Baseline up to 12 months
measure: Disease Control Rate
timeFrame: Baseline up to 12 months
measure: Clinical Benefit Rate
timeFrame: From the first dose to complete response, partial response, or stable disease for ≥24 weeks
measure: Overall Survival
timeFrame: Baseline up to 24 months
measure: Adverse event (AE)
timeFrame: 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)
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affilliated Hospital of Bengbu Medical University
state: Anhui
city: Jiangmen
country: China
facility: Jiangmen Central Hospital
state: Guangdong
city: Xingtai
country: China
facility: Xingtai People's Hospital
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hostipal
state: Heilongjiang
city: Luohe
country: China
facility: Luohe Central Hospital
state: Henan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Provincial People's Hospital
state: Jiangsu
city: Nantong
country: China
facility: Hai'an People's Hospital
state: Jiangsu
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
city: Jinan
country: China
facility: Cancer Hospital of Shandong First Medical University(Shandong Cancer Institute, Shandong Cancer Hospital)
state: Shandong
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiao Tong University
state: Shanxi
city: Luzhou
country: China
facility: The Affiliated Hospital of Southwest Medical University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
Study officials:
References: