PARP Inhibitor With CDK4/ 6 Inhibitor and Endocrine Thera... | NCT06612814

NCT06612814

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
First Hospital of China Medical University	OTHER
Sun Yat-sen University	OTHER
Chongqing University Cancer Hospital	OTHER
Fujian Medical University Union Hospital

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cohort 1	Experimental	In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with Fluzoparib(Parp inhibitor) and endocrine therapy.	Drug: Fluzoparib Drug: Dalpiciclib Drug: Fulvestrant/AI
Cohort 2	Active Comparator	In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with endocrine therapy.	Drug: Dalpiciclib Drug: Fulvestrant/AI

Name	Type	Description	Arm Group Labels	Other Names
Fluzoparib	Drug	Parp inhibitor	Cohort 1
Dalpiciclib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PFS	time to progressive disease (according to RECIST1.1)	Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)

Secondary Outcomes

Measure	Description	Time Frame
ORR	The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1)	andomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 5 years)
CBR

Eligibility Module

Eligibility 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).

ID	Term
C000722917	fluzoparib
C000720752	dalpiciclib