Clinical trial NCT05189717: A Trial of HRS-8080 Tablets in Metastatic or Local Advanced Breast Cancer of Adults
Official title: A Single-arm, Open-label and Multi-center Phase I Study on Safety, Tolerance and Pharmacokinetics of HRS-8080 Tablets Monotherapy and Combined With Other Anti-cancer Therapy in Patients With Metastatic or Local Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Metastatic or Local Advanced Breast Cancer of Patients
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-12
Enrollment: 156
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: HRS-8080 tablets monotherapy and combined with other anti-cancer therapy
Primary purpose: TREATMENT

Brief summary: The study is being conducted to evaluate the tolerance, and safety of HRS-8080 tablets monotherapy and combined with other anti-cancer therapy for metastatic or local advanced breast cancer in adults. To explore the reasonable dosage of HRS-8080 tablets for metastatic or local advanced breast cancer.


Eligibility criteria: Inclusion Criteria:

1. ECOG performance status score: 0-1;
2. Histopathologically documented local advanced or metastatic breast cancer ;
3. Female of not childbearing potential must the related requirement;
4. During or after the last systematic therapy before enrolment, disease progression occurred with clinical or radiographical documentation;
5. Adequate organ functions as defined;
6. Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.

Exclusion Criteria:

1. For the case of symptomatic visceral metastasis, the investigators judged that it was not suitable to use relevant treatment;
2. patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ;
3. History of clinically significant cardiovascular or cerebrovascular diseases;
4. The subject has one of many factors affecting oral drugs;
5. Active infection or fever with unknown cause \> 38.5 °C;
6. Active autoimmune diseases, History of immunodeficiency, including positive HIV serum test result and other acquired or congenital immunodeficiency diseases, or history of organ transplantation;
7. Known history of allergy to study drug ingredients.

Primary outcomes:
measure: Maximum tolerated dose
timeFrame: up to 28 days
measure: Recommended phase II dose
timeFrame: up to 28 days
measure: Incidence and severity of adverse events (AEs)/serious adverse events (SAEs)
timeFrame: up to 30 days after the last dose
Secondary outcomes:
measure: Cmax
timeFrame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
measure: Tmax
timeFrame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
measure: AUC0-t
timeFrame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
measure: Cmax,ss
timeFrame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
measure: Tmax,ss
timeFrame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
measure: Cmin,ss
timeFrame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
measure: AUCss
timeFrame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
measure: Rac
timeFrame: 0.5 hour before first dose of first treatment period to the 0.5 hour before first dose of fifth treatment period
measure: ORR
timeFrame: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months
measure: BOR
timeFrame: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months
measure: DoR
timeFrame: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months
measure: DCR
timeFrame: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months
measure: PFS
timeFrame: from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 8 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fifth Medical Center of People's Liberation Army of China General Hospital
state: Beijing
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
Study officials:
References: