Breast CancerPhase 2FACETNCT07716046
Fulvestaciclib Combined With Anti-HER2 and Endocrine Therapy for HR+/HER2+ Advanced Breast Cancer
A Phase 2 study testing Fulvestaciclib, Trastuzumab and Pertuzumab in people with Breast Cancer and HER2-positive Breast Cancer, run by Fudan University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor-positive Breast Cancer
- What is being tested?
- Fulvestaciclib, Trastuzumab and Pertuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 31 Dec 2032
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years, with inoperable locally advanced or recurrent/metastatic breast cancer not amenable to curative-intent therapy.
- Histologically or cytologically confirmed hormone receptor-positive (HR+) and HER2-positive (HER2+) breast cancer. HR+ is defined as estrogen receptor (ER) and/or progesterone receptor (PR) positivity with ≥1% of invasive tumor cells positive by immunohistochemistry (IHC). HER2+ is defined as IHC 3+ or IHC 2+ with in situ hybridization (ISH) positivity.
- No prior systemic therapy for advanced breast cancer, including endocrine therapy, chemotherapy, anti-HER2 therapy, or any CDK4/6 inhibitor.
- Patients may have received neoadjuvant or adjuvant therapy. If prior endocrine therapy was received in the neoadjuvant/adjuvant setting, the disease-free interval from completion of endocrine therapy to randomization must be ≥12 months. If prior anti-HER2 therapy was received, the disease-free interval from completion of anti-HER2 therapy to randomization must be ≥6 months.
- Patients with stable central nervous system (CNS) metastases (meeting all the following criteria: no disease progression on screening imaging after local therapy; at least 3 weeks from completion of local CNS therapy to Cycle 1 Day 1; no requirement for medication to control symptoms) or asymptomatic CNS metastases are eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
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- Any menopausal status. Postmenopausal status is defined as: a. bilateral oophorectomy; b. age ≥60 years; c. age <60 years with amenorrhea for >1 year in the absence of chemotherapy, tamoxifen, toremifene, or ovarian function suppression, and with serum FSH and estradiol levels within the postmenopausal range. For patients <60 years on tamoxifen or toremifene with amenorrhea, serum FSH and estradiol levels must be within the postmenopausal range on consecutive measurements.
- At least one evaluable lesion per RECIST 1.1 (measurable and/or non-measurable lesion).
- For women of childbearing potential: negative serum or urine pregnancy test within 7 days prior to randomization, and agreement to use adequate contraception during study treatment and for 6 months after the last dose of fulvestaciclib.
- Voluntarily sign the informed consent form (ICF), understand the study, and be willing to comply with all study procedures and follow-up.
- Adequate bone marrow and organ function defined as:
- 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%.
Who cannot join
- Inflammatory breast cancer.
- Leptomeningeal disease.
- Active brain metastases (patients with asymptomatic brain metastases, or clinically stable and not requiring steroids or other CNS-directed therapy for ≥4 weeks are eligible).
- Diagnosis of any other malignancy, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix that has been definitively treated.
- Known severe hypersensitivity to any component of the study drugs.
- Myocardial infarction within 6 months prior to first dose; uncontrolled cardiac arrhythmias (QTc interval ≥470 ms by Fridericia's formula); New York Heart Association (NYHA) Class III-IV cardiac insufficiency; LVEF <50% on echocardiography; or clinically significant pleural effusion, pericardial effusion, or ascites requiring intervention.
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- Dysphagia, active gastrointestinal disease, major gastrointestinal surgery, malabsorption syndrome, or any other condition that may interfere with the absorption of study drugs.
- Known active infection, including hepatitis B (HBsAg positive with HBV DNA ≥1×10⁴ copies/mL or ≥2000 IU/mL), hepatitis C, syphilis, or human immunodeficiency virus (HIV) infection.
- Major surgery, radiotherapy, tumor immunotherapy, monoclonal antibody therapy, or other systemic antitumor therapy within 30 days prior to the first dose, or any therapy that the investigator considers may interfere with the efficacy of study drugs.
- Concurrent use of other investigational drugs or therapies.
- Planned or prior organ or bone marrow transplantation.
- Known history of substance abuse or drug addiction.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Fulvestaciclib Combined With Anti-HER2 and Endocrine Therapy for First-line Maintenance or Upfront Chemo-Free Treatment in HR+/HER2+ Advanced Breast Cancer: A Multicenter, Open-label, Randomized Controlled Phase II Study
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).
Read more
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
- Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor-positive Breast Cancer, HR+/HER2+ Breast Cancer
- Being tested
- Fulvestaciclib, Trastuzumab, Pertuzumab, Fulvestrant, Letrozole
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FulvestaciclibDrug
Also called HLX902
Oral CDK4/6 inhibitor, 200 mg once daily, 21 days on/7 days off per 28-day cycle.
TrastuzumabBiological
Anti-HER2 monoclonal antibody, 8 mg/kg loading dose then 6 mg/kg IV every 21 days.
PertuzumabBiological
Anti-HER2 monoclonal antibody, 840 mg loading dose then 420 mg IV every 21 days.
FulvestrantDrug
Fulvestrant
LetrozoleDrug
Aromatase inhibitor, 2.5 mg orally once daily.
AnastrozoleDrug
Aromatase inhibitor, 1 mg orally once daily.
TaxaneDrug
Induction chemotherapy (paclitaxel, docetaxel, or nab-paclitaxel) plus HP for 4-8 cycles prior to maintenance therapy.
| Study group | Role | What they receive |
|---|---|---|
| Fulvestaciclib + HP + ET Maintenance | Experimental | 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. Receives: Drug: Fulvestaciclib; Biological: Trastuzumab; Biological: Pertuzumab; Drug: Fulvestrant; Drug: Letrozole; Drug: Anastrozole; Drug: Taxane |
| HP + ET Maintenance (Control) | Active comparator | 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. Receives: Biological: Trastuzumab; Biological: Pertuzumab; Drug: Fulvestrant; Drug: Letrozole; Drug: Anastrozole; Drug: Taxane |
| Upfront Fulvestaciclib + HP + ET (Chemo-free) | Experimental | 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. Receives: Drug: Fulvestaciclib; Biological: Trastuzumab; Biological: Pertuzumab; Drug: Fulvestrant; Drug: Letrozole; Drug: Anastrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Secondary outcomes (8)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Henlius Biotech Co., Ltd.
- Responsible party
- Principal investigator, Jian Zhang,MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07716046
- Sponsor's protocol ID
- HLX902-IIT-MA-BC02
- Acronym
- FACET
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Fulvestaciclib Combined With Anti-HER2 and Endocrine Therapy for First-line Maintenance or Upfront Chemo-Free Treatment in HR+/HER2+ Advanced Breast Cancer: A Multicenter, Open-label, Randomized Controlled Phase II Study
- ClinicalTrials.gov ID
- NCT07716046
- Acronym / sponsor ID
- FACET / HLX902-IIT-MA-BC02
- Conditions
- Breast Cancer, HER2-positive Breast Cancer, Hormone Receptor-positive Breast Cancer, HR+/HER2+ Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Shanghai Henlius Biotech Co., Ltd.
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fulvestaciclib + HP + ET Maintenance | Experimental | Drug: Fulvestaciclib, Biological: Trastuzumab, Biological: Pertuzumab, Drug: Fulvestrant, Drug: Letrozole, Drug: Anastrozole, Drug: TaxaneAfter 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. |
| HP + ET Maintenance (Control) | Active comparator | Biological: Trastuzumab, Biological: Pertuzumab, Drug: Fulvestrant, Drug: Letrozole, Drug: Anastrozole, Drug: TaxaneAfter 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. |
| Upfront Fulvestaciclib + HP + ET (Chemo-free) | Experimental | Drug: Fulvestaciclib, Biological: Trastuzumab, Biological: Pertuzumab, Drug: Fulvestrant, Drug: Letrozole, Drug: AnastrozoleParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age ≥ 18 years, with inoperable locally advanced or recurrent/metastatic breast cancer not amenable to curative-intent therapy.
- Histologically or cytologically confirmed hormone receptor-positive (HR+) and HER2-positive (HER2+) breast cancer. HR+ is defined as estrogen receptor (ER) and/or progesterone receptor (PR) positivity with ≥1% of invasive tumor cells positive by immunohistochemistry (IHC). HER2+ is defined as IHC 3+ or IHC 2+ with in situ hybridization (ISH) positivity.
- No prior systemic therapy for advanced breast cancer, including endocrine therapy, chemotherapy, anti-HER2 therapy, or any CDK4/6 inhibitor.
- Patients may have received neoadjuvant or adjuvant therapy. If prior endocrine therapy was received in the neoadjuvant/adjuvant setting, the disease-free interval from completion of endocrine therapy to randomization must be ≥12 months. If prior anti-HER2 therapy was received, the disease-free interval from completion of anti-HER2 therapy to randomization must be ≥6 months.
- Patients with stable central nervous system (CNS) metastases (meeting all the following criteria: no disease progression on screening imaging after local therapy; at least 3 weeks from completion of local CNS therapy to Cycle 1 Day 1; no requirement for medication to control symptoms) or asymptomatic CNS metastases are eligible.
Key exclusion criteria (13 listed)
- Inflammatory breast cancer.
- Leptomeningeal disease.
- Active brain metastases (patients with asymptomatic brain metastases, or clinically stable and not requiring steroids or other CNS-directed therapy for ≥4 weeks are eligible).
- Diagnosis of any other malignancy, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix that has been definitively treated.
- Known severe hypersensitivity to any component of the study drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FulvestaciclibAlso: HLX902Oral CDK4/6 inhibitor, 200 mg once daily, 21 days on/7 days off per 28-day cycle. | Drug | Fulvestaciclib + HP + ET Maintenance, Upfront Fulvestaciclib + HP + ET (Chemo-free) |
| TrastuzumabAnti-HER2 monoclonal antibody, 8 mg/kg loading dose then 6 mg/kg IV every 21 days. | Biological | Fulvestaciclib + HP + ET Maintenance, HP + ET Maintenance (Control), Upfront Fulvestaciclib + HP + ET (Chemo-free) |
| PertuzumabAnti-HER2 monoclonal antibody, 840 mg loading dose then 420 mg IV every 21 days. | Biological | Fulvestaciclib + HP + ET Maintenance, HP + ET Maintenance (Control), Upfront Fulvestaciclib + HP + ET (Chemo-free) |
| FulvestrantFulvestrant | Drug | Fulvestaciclib + HP + ET Maintenance, HP + ET Maintenance (Control), Upfront Fulvestaciclib + HP + ET (Chemo-free) |
| LetrozoleAromatase inhibitor, 2.5 mg orally once daily. | Drug | Fulvestaciclib + HP + ET Maintenance, HP + ET Maintenance (Control), Upfront Fulvestaciclib + HP + ET (Chemo-free) |
| AnastrozoleAromatase inhibitor, 1 mg orally once daily. | Drug | Fulvestaciclib + HP + ET Maintenance, HP + ET Maintenance (Control), Upfront Fulvestaciclib + HP + ET (Chemo-free) |
| TaxaneInduction chemotherapy (paclitaxel, docetaxel, or nab-paclitaxel) plus HP for 4-8 cycles prior to maintenance therapy. | Drug | Fulvestaciclib + HP + ET Maintenance, HP + ET Maintenance (Control) |
Primary outcome
Progression-Free Survival (PFS) Assessed by Investigator
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.
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.
8 secondary outcomes
Progression-Free Survival (PFS) Assessed by Investigator (Arm A vs Arm C)
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)
Time frame: From date of randomization to date of death from any cause, assessed up to approximately 6 years.
Objective Response Rate (ORR)
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)
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)
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
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
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
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fulvestaciclib, Trastuzumab and Pertuzumab in people with Breast Cancer and HER2-positive Breast Cancer, run by Fudan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhang, MD (+86 18017312991, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) Assessed by Investigator (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.