SHR9549 in ER Positive HER2 Negative Advanced Breast Cancer
- Registration Number
- NCT03596658
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
This is a phase 1 open label multicentre study of SHR9549 administered orally in patients with advanced estrogen receptor (ER) positive human epidermal receptor 2 (HER2) negative breast cancer. The study design allows an escalation of dose with intensive safety monitoring to ensure the safety of patients. The study will determine the maximum tolerated dose(MTD). In addition, expansion cohort(s) at potential therapeutic dose(s) in patients will be enrolled to further determine the safety, tolerability, pharmacokinetics and biological activity of SHR9549.
- Detailed Description
A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of SHR9549 in Women with Estrogen Receptor (ER) Positive Human Epidermal Receptor (HER-2) Negative Advanced Breast Cancer
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 4
- Aged 18-70 years.
- Confirmation of ER positive; HER2 negative Advanced breast cancer
- Documented disease progression after at least 6 months prior endocrine therapy for ER positive breast cancer.
- Receipt of ≤2 lines of prior chemotherapy for advanced disease.
- Any menopausal status.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 and with minimum life expectancy of 12 weeks.
- Any anti-cancer drugs for the treatment of advanced breast cancer within 14 days of the first dose of study treatment.
- Any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment with the exception of alopecia.
- Patient who is unsuitable for endocrine therapy alone including presence of life-threatening metastatic visceral disease.
- uncontrolled central nervous system metastatic disease.
- Any evidence of severe or uncontrolled systemic diseases.
- Inadequate bone marrow reserve or organ function.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SHR9549 dose escalation and expansion(s) SHR9549 Escalating dose of SHR9549 with intensive safety monitoring to ensure the safety of patients
- Primary Outcome Measures
Name Time Method Maximum Tolerated Dose (MTD) baseline through 28 days to determine MTD in order to assess the tolerability of SHR9549
Dose Limited Toxicity (DLT) baseline through 28 days to determine DLT in order to assess the tolerability of SHR9549
- Secondary Outcome Measures
Name Time Method Peak Plasma Concentration (Cmax) baseline through 12 weeks Single and multiple dose pharmacokinetic parameters of SHR9549 at pre-defined intervals
overall response rate (ORR) every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
progression free survival (PFS) every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months Antitumour activity evaluation by following up patients' progression and survival
Incidence of Treatment-Emergent Adverse Events baseline through 30 days after study completion to assess the safety of SHR9549
Area under the plasma concentration versus time curve (AUC) baseline through 12 weeks Single and multiple dose pharmacokinetic parameters of SHR9549 at pre-defined intervals
Trial Locations
- Locations (1)
The 307th Hospital of Military Chinese People's Liberation Army
🇨🇳Beijing, Beijing, China