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Recruiting Phase 2

PARP Inhibitor With CDK4/6 Inhibitor and Endocrine Therapy in HR+/ HER2-Advanced Breast Cancer

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About this study

This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.

Condition
Breast Cancer Metastatic
Tested
Fluzoparib, Dalpiciclib, Fulvestrant/AI
Sponsor
Fudan University

Who can join

Age
18 to 75 years
Sex
Female only
Healthy volunteers
Not accepted

Inclusion 14

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Eligible sex: Female
  • Study condition: Breast Cancer Metastatic
  • 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.

Exclusion 5

  • 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

1 site, 1 recruiting

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.