SHR9549 in ER Positive HER2 Negative Advanced Breast Cancer
NCT ID: NCT03596658
Last Updated: 2022-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
4 participants
INTERVENTIONAL
2018-07-25
2019-10-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SHR9549 dose escalation and expansion(s)
Escalating dose of SHR9549 with intensive safety monitoring to ensure the safety of patients
SHR9549
If initial dosing of SHR9549 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose(MTD) is defined
Interventions
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SHR9549
If initial dosing of SHR9549 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose(MTD) is defined
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
FEMALE
No
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The 307th Hospital of Military Chinese People's Liberation Army
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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SHR9549-I-101
Identifier Type: -
Identifier Source: org_study_id
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