A Phase 2 interventional study of Fulvestaciclib and Trastuzumab in Breast Cancer, HER2-positive Breast Cancer and Hormone Receptor-positive Breast Cancer, sponsored by Fudan University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Fudan University · Phase 2, Interventional, and Treatment
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).
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 240 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Fudan University is the lead sponsor of 1,270 studies on the registry; 623 are open to participants now.
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Absolute neutrophil count (ANC) ≥1.5 × 10⁹/L; Hemoglobin ≥90 g/L (no red blood cell transfusion within 14 days prior to randomization); Platelet count ≥75 × 10⁹/L; Serum total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤3 × ULN (or ≤5 × ULN in the presence of liver metastases); Serum creatinine ≤1 × ULN or calculated creatinine clearance >50 mL/min (Cockcroft-Gault formula); Baseline left ventricular ejection fraction (LVEF) ≥50%.
Exclusion Criteria:
After 4-8 cycles of induction chemotherapy (taxane) plus trastuzumab and pertuzumab (HP), participants receive maintenance therapy with oral fulvestaciclib 200 mg daily (21 days on, 7 days off, 28-day cycle), HP (trastuzumab 8 mg/kg loading then 6 mg/kg IV Q3W; pertuzumab 840 mg loading then 420 mg IV Q3W), and endocrine therapy (ET: fulvestrant 500 mg IM on Days 1,15,29 then monthly, or letrozole 2.5 mg or anastrozole 1 mg PO daily). Premenopausal/perimenopausal patients also receive ovarian function suppression (OFS). Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Drug: Fulvestaciclib · Biological: Trastuzumab · Biological: Pertuzumab · Drug: Fulvestrant · Drug: Letrozole · Drug: Anastrozole · Drug: Taxane
After 4-8 cycles of induction chemotherapy (taxane) plus trastuzumab and pertuzumab (HP), participants receive maintenance therapy with HP (trastuzumab 8 mg/kg loading then 6 mg/kg IV Q3W; pertuzumab 840 mg loading then 420 mg IV Q3W) and endocrine therapy (ET: fulvestrant 500 mg IM on Days 1,15,29 then monthly, or letrozole 2.5 mg or anastrozole 1 mg PO daily) without fulvestaciclib. Premenopausal/perimenopausal patients also receive ovarian function suppression (OFS). Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Biological: Trastuzumab · Biological: Pertuzumab · Drug: Fulvestrant · Drug: Letrozole · Drug: Anastrozole · Drug: Taxane
Participants receive first-line therapy with oral fulvestaciclib 200 mg daily (21 days on, 7 days off, 28-day cycle), HP (trastuzumab 8 mg/kg loading then 6 mg/kg IV Q3W; pertuzumab 840 mg loading then 420 mg IV Q3W), and endocrine therapy (ET: fulvestrant 500 mg IM on Days 1,15,29 then monthly, or letrozole 2.5 mg or anastrozole 1 mg PO daily) without induction chemotherapy. Premenopausal/perimenopausal patients also receive ovarian function suppression (OFS). Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or death.
Drug: Fulvestaciclib · Biological: Trastuzumab · Biological: Pertuzumab · Drug: Fulvestrant · Drug: Letrozole · Drug: Anastrozole
Oral CDK4/6 inhibitor, 200 mg once daily, 21 days on/7 days off per 28-day cycle.
Also known as: HLX902
Anti-HER2 monoclonal antibody, 8 mg/kg loading dose then 6 mg/kg IV every 21 days.
Anti-HER2 monoclonal antibody, 840 mg loading dose then 420 mg IV every 21 days.
Fulvestrant
Aromatase inhibitor, 2.5 mg orally once daily.
Aromatase inhibitor, 1 mg orally once daily.
Induction chemotherapy (paclitaxel, docetaxel, or nab-paclitaxel) plus HP for 4-8 cycles prior to maintenance therapy.
Progression-Free Survival (PFS) Assessed by Investigator
PFS is defined as the time from randomization to the first documented disease progression according to RECIST 1.1 criteria as assessed by the investigator, or death from any cause, whichever occurs first.
Time frame: From randomization to first documented progression per RECIST 1.1 or death, assessed every 6 weeks for 12 weeks then every 12 weeks until progression, up to 6 years.
Progression-Free Survival (PFS) Assessed by Investigator (Arm A vs Arm C)
PFS is defined as the time from randomization to the first documented disease progression according to RECIST 1.1 criteria as assessed by the investigator, or death from any cause, whichever occurs first. Comparison between Arm A (fulvestaciclib + HP + ET maintenance) and Arm C (upfront fulvestaciclib + HP + ET chemo-free).
Time frame: From randomization to first documented progression per RECIST 1.1 or death, assessed every 6 weeks for 12 weeks then every 12 weeks until progression, up to 6 years.
Overall Survival (OS)
OS is defined as the time from randomization to death from any cause.
Time frame: From date of randomization to date of death from any cause, assessed up to approximately 6 years.
Objective Response Rate (ORR)
ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 criteria as assessed by the investigator.
Time frame: From randomization to progression or start of subsequent therapy, assessed every 6 weeks for 12 weeks then every 12 weeks, up to 6 years.
Clinical Benefit Rate (CBR)
CBR is defined as the proportion of patients with a best overall response of CR, PR, or stable disease lasting at least 24 weeks per RECIST 1.1 criteria as assessed by the investigator.
Time frame: From randomization to progression or start of subsequent therapy, assessed every 6 weeks for 12 weeks then every 12 weeks, up to 6 years.
Duration of Response (DoR)
DoR is defined as the time from the first documented response (CR or PR) to the first documented disease progression per RECIST 1.1 criteria as assessed by the investigator, or death from any cause, whichever occurs first.
Time frame: From first documented CR or PR to first progression per RECIST 1.1 or death, assessed up to 6 years.
Cumulative Incidence of Central Nervous System (CNS) Metastases
Cumulative incidence of CNS metastases will be estimated using the competing risk model (Gray's method), with death as a competing risk event.
Time frame: From date of randomization to date of first documented CNS metastasis, assessed up to approximately 6 years.
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) as Assessed by NCI-CTCAE v5.0
Safety and tolerability will be assessed by the incidence, severity, and causality of AEs and SAEs graded according to NCI-CTCAE v5.0, as well as changes in vital signs, 12-lead ECGs, echocardiograms, and clinical laboratory parameters.
Time frame: From informed consent through 28 days after last dose; labs/ECGs every 3 weeks, echocardiograms every 12 weeks, up to 6 years.
Patient-Reported Outcomes (PROs) Assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B) Questionnaire
Health-related quality of life assessed using FACT-B, a 36-item scale across 5 domains: physical, social/family, emotional, functional well-being, and breast cancer-specific concerns. Total scores range from 0 to 148, with higher scores indicating better quality of life.
Time frame: Measured at Cycle 1 Day 1 (each cycle is 28 days), every 12 weeks thereafter, and at treatment discontinuation and safety follow-up, up to 6 years.
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