PARP Inhibitor With CDK4/ 6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer
NCT ID: NCT06612814
Last Updated: 2024-09-25
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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ACTIVE_NOT_RECRUITING
PHASE3
307 participants
INTERVENTIONAL
2024-09-01
2028-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Cohort 1
In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with Fluzoparib(Parp inhibitor) and endocrine therapy.
Fluzoparib
Parp inhibitor
Dalpiciclib
CDK4/6 inhibitor
Fulvestrant/AI
Endocrine therapy
Cohort 2
In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with endocrine therapy.
Dalpiciclib
CDK4/6 inhibitor
Fulvestrant/AI
Endocrine therapy
Interventions
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Fluzoparib
Parp inhibitor
Dalpiciclib
CDK4/6 inhibitor
Fulvestrant/AI
Endocrine therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed HR + / HER2- invasive breast cancer (specific definition: immunohistochemical detection of ER \> 10% tumor cell positive is defined as ER positive, PR \> 10% tumor cell positive is defined as PR positive, ER and / or PR Positive is defined as HR positive; HER2 0-1 + or HER2 is ++ but negative followed by FISH detection, no amplification, defined as HER2 negative);
* Subtype of similarity network fusion-3 (SNF-3) confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital • Locally advanced breast cancer (incapable of radical local treatment) or recurrent metastatic breast cancer;
* Measurable disease according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1); or unmeasurable lytic or mixed (osteolytic + osteoblastic) bone lesions in the absence of measurable lesions;
* Has adequate bone marrow function: absolute neutrophil count \> 1.5x10ˆ9 /L; platelet count \> 75x10ˆ9 /L, hemoglobin \> 9g/dL;
* Patients had received no previous chemotherapy or targeted therapy for metastatic disease
* Has adequate liver function and kidney function: serum creatinine
* ECOG score ≤ 2 and life expectancy ≥ 3 months;
* Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up.
Exclusion Criteria
* Symptomatic, untreated, or actively progressing CNS metastases(glucocorticoids or mannitol needed to control symptoms);
* Significant cardiovascular disease(including congestive heart failure, angina pectoris, myocardial infarction or ventricular arrhythmia in the last 6 months);
* is pregnant or breast feeding;
* Malignant tumors in the past five years (except cured skin basal cell carcinoma and cervical carcinoma in situ).
18 Years
75 Years
FEMALE
No
Sponsors
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First Hospital of China Medical University
OTHER
Sun Yat-sen University
OTHER
Chongqing University Cancer Hospital
OTHER
Fujian Medical University Union Hospital
OTHER
Ningbo Medical Center Lihuili Hospital
OTHER_GOV
Shanghai First Maternity and Infant Hospital
OTHER
Affiliated Hospital of Nantong University
OTHER
Peking University Cancer Hospital & Institute
OTHER
First Affiliated Hospital Xi'an Jiaotong University
OTHER
Liaoning Cancer Hospital & Institute
OTHER
Northern Jiangsu People's Hospital
OTHER
Shanghai 6th People's Hospital
OTHER
Zhimin Shao
OTHER
Responsible Party
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Zhimin Shao
director
Locations
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breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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SCHBCC-N080
Identifier Type: -
Identifier Source: org_study_id
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