SHR9549 in ER Positive HER2 Negative Advanced Breast Cancer

ER+ HER2- Advanced Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03596658
• Other study ID #: SHR9549-I-101
• Status: Terminated
• Phase: Phase 1
• Start date: July 25, 2018
• Est. completion date: October 14, 2019

Study information

• Verified date: July 2018
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 14, 2019
• Est. primary completion date: October 14, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• ER+ HER2- Advanced Breast Cancer

Intervention

Drug:
• SHR9549
If initial dosing of SHR9549 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose(MTD) is defined

Locations

Country	Name	City	State
China	The 307th Hospital of Military Chinese People's Liberation Army	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose Limited Toxicity (DLT)	to determine DLT in order to assess the tolerability of SHR9549	baseline through 28 days
Primary	Maximum Tolerated Dose (MTD)	to determine MTD in order to assess the tolerability of SHR9549	baseline through 28 days
Secondary	Peak Plasma Concentration (Cmax)	Single and multiple dose pharmacokinetic parameters of SHR9549 at pre-defined intervals	baseline through 12 weeks
Secondary	Area under the plasma concentration versus time curve (AUC)	Single and multiple dose pharmacokinetic parameters of SHR9549 at pre-defined intervals	baseline through 12 weeks
Secondary	overall response rate (ORR)	Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)	every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months
Secondary	progression free survival (PFS)	Antitumour activity evaluation by following up patients' progression and survival	every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months
Secondary	Incidence of Treatment-Emergent Adverse Events	to assess the safety of SHR9549	baseline through 30 days after study completion