SHR9549 in ER Positive HER2 Negative Advanced Breast Cancer

Phase 1TerminatedNCT03596658

Jiangsu HengRui Medicine Co., Ltd.4 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

ER+ HER2- Advanced Breast Cancer

Interventions

SHR9549DRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

The 307th Hospital of Military Chinese People's Liberation Army

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Dose Limited Toxicity (DLT)

to determine DLT in order to assess the tolerability of SHR9549

Time frame: baseline through 28 days

Maximum Tolerated Dose (MTD)

to determine MTD in order to assess the tolerability of SHR9549

Time frame: baseline through 28 days

Secondary Outcomes

Peak Plasma Concentration (Cmax)

Single and multiple dose pharmacokinetic parameters of SHR9549 at pre-defined intervals

Time frame: baseline through 12 weeks

Area under the plasma concentration versus time curve (AUC)

Single and multiple dose pharmacokinetic parameters of SHR9549 at pre-defined intervals

Time frame: baseline through 12 weeks

overall response rate (ORR)

Antitumour activity by evaluation of tumour response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)

Time frame: every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months

progression free survival (PFS)

Antitumour activity evaluation by following up patients' progression and survival

Time frame: every 8 weeks for 24 weeks and then every 12 weeks thereafter through study completion, an average of 6 months

Incidence of Treatment-Emergent Adverse Events

to assess the safety of SHR9549

Time frame: baseline through 30 days after study completion

Data from ClinicalTrials.gov

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