Overview

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

Status:
Recruiting
Trial end date:
2027-06-01
Target enrollment:
0
Participant gender:
Female
Summary
This study is a prospective, open-label, phase II clinical study for patients with HR+/HER2- advanced breast cancer.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Fudan University
Treatments:
Fulvestrant
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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).