PARP Inhibitor With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer
Recruiting now · Phase 2
Conditions studied: Breast Cancer Metastatic
In brief
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
Key facts
- Study ID
- NCT05759546
- Run by
- Fudan University
- People needed
- 200
- Starts
- 2023-02-01
- Expected to finish
- 2027-06-01
- Last updated by the study team
- 2024-02-06
Who can join
Age: 18 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Females ≥18 years and ≤ 75 years old;
- 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.
You may not qualify if…
- Treatment with chemotherapy, radiotherapy, immunotherapy or surgery (outpatient clinic surgery excluded) for metastatic disease
- 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).
Where it is running
- Breast cancer institute of Fudan University Cancer Hospital — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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