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

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2027-06-01

Brief Summary

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

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Detailed Description

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Patients with SNF34subtype of HR+/HER2- advanced breast cancer confirmed by the Department of Pathology and Key Laboratory of Breast Cancer of Fudan University Affiliated Cancer Hospital are planned to be enrolled. The main purpose is to evaluate efficacy of Apatinib in SNF4 subtype of HR

+/HER2- advanced breast cancer and prepare for subsequent randomized controlled phase III clinical studies with larger sample size.

Conditions

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Breast Cancer Metastatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with Apatinib and endocrine therapy.

Group Type EXPERIMENTAL

Apatinib

Intervention Type DRUG

TKI

Dalpiciclib

Intervention Type DRUG

CDK4/6 inhibitor

Fulvestrant/AI

Intervention Type DRUG

Endocrine therapy

Cohort 2

In this cohort, a patient would receive Dalpiciclib(CDK4/6 inhibitor) combined with endocrine therapy.

Group Type ACTIVE_COMPARATOR

Dalpiciclib

Intervention Type DRUG

CDK4/6 inhibitor

Fulvestrant/AI

Intervention Type DRUG

Endocrine therapy

Interventions

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Apatinib

TKI

Intervention Type DRUG

Dalpiciclib

CDK4/6 inhibitor

Intervention Type DRUG

Fulvestrant/AI

Endocrine therapy

Intervention Type DRUG

Eligibility Criteria

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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-4 (SNF-4) 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

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* 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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No