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Fulvestaciclib Combined With Anti-HER2 and Endocrine Therapy for HR+/HER2+ Advanced Breast Cancer

NCT07716046 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2026-07-21

No results posted yet for this study

Summary

This phase II, multicenter, open-label, randomized controlled trial (FACET study) evaluates the efficacy and safety of fulvestaciclib, a novel oral CDK4/6 inhibitor, combined with anti-HER2 dual blockade (trastuzumab and pertuzumab, HP) and endocrine therapy (ET) in hormone receptor-positive (HR+) and HER2-positive advanced breast cancer (ABC).

Patients with HR+/HER2+ ABC without prior systemic therapy for advanced disease are randomized in a 1:1:1 ratio into three arms, stratified by visceral metastasis status (yes vs. no) and metastatic type (de novo vs. recurrent).

Arm A: After 4-8 cycles of induction chemotherapy (taxane) plus HP, patients receive fulvestaciclib + HP + ET as maintenance therapy.

Arm B: After 4-8 cycles of induction chemotherapy (taxane) plus HP, patients receive HP + ET alone (without fulvestaciclib) as maintenance therapy.

Arm C (exploratory): Patients receive upfront fulvestaciclib + HP + ET as first-line therapy without induction chemotherapy (chemo-free).

For premenopausal/perimenopausal patients, ovarian function suppression (OFS) is added in all arms. Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or death.

The primary endpoint is investigator-assessed progression-free survival (PFS) comparing Arm A versus Arm B. Secondary endpoints include PFS (Arm A vs. Arm C), overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR), duration of response (DoR), cumulative incidence of central nervous system (CNS) metastases, safety, and patient-reported outcomes (PROs).

Conditions

Interventions

DRUG

Fulvestaciclib

Oral CDK4/6 inhibitor, 200 mg once daily, 21 days on/7 days off per 28-day cycle.

BIOLOGICAL

Trastuzumab

Anti-HER2 monoclonal antibody, 8 mg/kg loading dose then 6 mg/kg IV every 21 days.

BIOLOGICAL

Pertuzumab

Anti-HER2 monoclonal antibody, 840 mg loading dose then 420 mg IV every 21 days.

DRUG

Fulvestrant

Fulvestrant

DRUG

Letrozole

Aromatase inhibitor, 2.5 mg orally once daily.

DRUG

Anastrozole

Aromatase inhibitor, 1 mg orally once daily.

DRUG

Taxane

Induction chemotherapy (paclitaxel, docetaxel, or nab-paclitaxel) plus HP for 4-8 cycles prior to maintenance therapy.

Sponsors & Collaborators

  • Shanghai Henlius Biotech Co., Ltd.

    collaborator UNKNOWN

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2030-08-31
Completion
2032-12-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07716046 on ClinicalTrials.gov