Clinical trial NCT03596658: SHR9549 in ER Positive HER2 Negative Advanced Breast Cancer
Official title: 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 ER Positive HER2 Negative Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: ER+ HER2- Advanced Breast Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-07-24
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Dose Limited Toxicity (DLT)
timeFrame: baseline through 28 days
measure: Maximum Tolerated Dose (MTD)
timeFrame: baseline through 28 days
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: baseline through 12 weeks
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: baseline through 12 weeks
measure: overall response rate (ORR)
timeFrame: every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months
measure: progression free survival (PFS)
timeFrame: every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: baseline through 30 days after study completion
Other outcomes:
Locations:
city: Beijing
country: China
facility: The 307th Hospital of Military Chinese People's Liberation Army
state: Beijing
Study officials:
References: