Health TrialsbyHealthPanel

Apatinib Combined With cdk4/6i in First-line Treatment for HR+/HER2- SNF4 Subtype Breast Cancer

ConditionsAdvanced Breast CancerHR+/HER2- Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorFudan University

About this trial

This is a randomized, controlled, open-label, phase III study to explore the efficacy and safety of Apatinib in combination with standard first-line endocrine therapy for the HR+/ HER2-SNF4 subtype of advanced breast cancer. The study was used to explore the efficacy of Apatinib in combination with standard endocrine therapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients need to meet all of the following conditions

Patients must be ≥18 and ≤ 75 years of age;

Pathologically confirmed breast cancer is HR+/HER2- breast cancer (IHC ER >10%, or/and PR>10%, HER 0 OR +, if HER2++, FISH negative);

SNF4 subtype definition: SNF4 subtype confirmed by digital pathology of H&E sections;

Disqualifiers

Patients with any of the following conditions were excluded from the study

Patients with central nervous system metastasis out of control (symptoms need to use glucocorticoids or mannitol).

A history of clinically significant or uncontrolled heart disease, including congestive heart failure, angina pectoris, myocardial infarction within the last 6 months, or ventricular arrhythmia;

Radiotherapy, chemotherapy, surgery, other targeted therapy, and immunotherapy for advanced HR+/HER2- breast cancer within 4 weeks before the first administration of drugs used in this study.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Apatinib

    Drug

    Apatinib is a kind of TKI inhibitor.

  • CDK4/6 Inhibitor

    Drug

    Dalpiciclib (SHR6390) is a kind of CDK4/6 inhibitor that has demonstrated tolerability and preliminary clinical activity in patients with heavily pretreated hormone receptor-positive, HER2-negative advanced breast cancer.

  • Aromatase inhibitor and Fulvestrant

    Drug

    Endocrine therapy combined with CDK4/6 inhibitors is the standard first-line therapy for advanced luminal breast cancer. Investigators choose endocrine therapy including Letrozole, Anastrozole, Exemestane, and Fulvestrant. Postmenopausal participants should use Goserelin.

Treatment groups

184 Participants
are divided into 2 treatment groups
Group A: Arm-AExperimental treatment 3 interventions
Group B: Arm-BActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS)

The interval from randomization until the first occurrence of disease progression (according to RECIST 1.1) or death from any cause, which ever occurs first.

Time frame
Approximately 5 years

Secondary outcomes

1

Clinical Benefit Rate (CBR)

CBR is the total percentage of participants who achieved a complete response, partial response, or had stable disease for 6 months or more.

Time frame
Approximately 5 years
2

Objective Response Rate (ORR)

ORR is defined as the proportion of participants who have a complete response (CR) or partial response (PR) based on BICR and investigator assessment using RECIST 1.1.

Time frame
Approximately 5 years
3

Overall Survival (OS)

OS is defined as the time from randomisation until the date of death due to any cause.

Time frame
Approximately 5 years
4

Safety and tolerability

Number of adverse events according to NCI-CTCAE Version 5.0 per each treatment arm.

Time frame
Approximately 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
Apply now