AzTrials
AzTrials

Breast Neoplasm FemalePhase 2NCT05969184

Palbociclib Combine With Anti-HER2 Therapy in Triple Positive ABC

A Phase 2 study testing CDK4/6 inhibitor (Qilu),Trastuzumab (Hanquyou) in people with Breast Neoplasm Female, run by Peking University Cancer Hospital & Institute at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is to find out that if HER-2 positive and HR positive patients could benefit from trastuzumab and pertuzumab combined with palbociclib and endocrine therapy. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasm Female
What is being tested?
CDK4/6 inhibitor (Qilu),Trastuzumab (Hanquyou)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
2 sitesChina
Study dates
12 Dec 2021to 25 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign the informed consent form and agree to comply with the requirements of the research protocol
  • Recurrent or metastatic breast cancer confirmed by histology or cytology that cannot be operated, and has not received systematic treatment for recurrent or metastatic breast cancer.
  • Estrogen receptor ER is positive (positive staining of ≥ 1% of tumor cell nucleus is positive) and HER2 is positive (immunohistochemistry is 3+, and/or 2+, and ISH is positive)
  • Age ≥ 18 years old.
  • ECOG physical status score is 0-1.
  • Life expectancy ≥ 3 months.
Show all 11Show fewer
  • Be in a postmenopausal state.
  • Suffer from one of the following diseases defined in RECIST 1.1, and the target lesion is not suitable for surgical treatment; The target lesion has not received radiotherapy or relapses in the radiotherapy field:
  • At least one measurable lesion as the target lesion confirmed by CT or MRI
  • Non measurable disease with only bone metastasis (osteogenic disease, osteolytic disease or osteolytic osteogenic mixture)
  • Appropriate hematopoietic function, liver function and kidney function

Who cannot join

  • Visceral crisis, severe organ dysfunction accompanied by clinical symptoms and signs, and the clinician judges that it is necessary to receive chemotherapy based treatment as soon as possible to obtain disease relief, including but not limited to the following situations: liver metastasis accompanied by a rapid increase of more than 1.5 times of bilirubin or more than 3 times of transaminase; Or pulmonary metastasis with dyspnea at rest; Carcinomatous lymphangitis; Bone marrow metastasis was accompanied by severe decrease of hematopoietic function; As well as asthma, inflammatory breast cancer, etc.
  • The subject has cancerous meningitis or has untreated central nervous system metastasis; Those who have received systematic and radical brain metastasis treatment (radiotherapy or surgery) in the past, and have been stable for at least 1 month as confirmed by imaging, and have stopped systemic hormone treatment (dose>10mg/day prednisone or other effective hormones) for more than 2 weeks, and have no clinical symptoms can be included.
  • over 2 kind of Systematic treatment for metastatic breast cancer, including chemotherapy, endocrine therapy and biological targeting therapy, has been used previously.
  • Have received any treatment of CDK4 and CDK6 inhibitors (or participated in any clinical trial of CDK4 and CDK6 inhibitors that have not been exposed).
  • Have received radiotherapy within 28 days before enrollment. It is allowed to receive radiotherapy for relieving metastatic bone pain before enrollment, but the irradiated medullary bone shall not exceed 30% of the total amount.
  • Patients with uncontrolled lung disease, severe infection, active digestive tract ulcer requiring treatment, coagulation disorders, severe uncontrolled diabetes, connective tissue disease or bone marrow function depression and other diseases cannot tolerate the study drug treatment.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Yaxin Liu

    Beijing, None Selected, 100042

Other trials in China

About this study

Official title: Palbociclib Combine With Endocrine Therapy and Anti-HER2 Therapy in HR Positive and HER2 Positive Advanced Breast Cancer

This study is to find out that if HER-2 positive and HR positive patients could benefit from trastuzumab and pertuzumab combined with palbociclib and endocrine therapy.

Read the detailed description

This study is a single-arm, open-label, multicenter, phase II clinical study. Subjects were eligible for screening and entered the trial period after enrollment and received treatment with palbociclib（125mg/day), trastuzumab(8 mg→6mg/every 3 week), pertuzumab(840 mg→420mg/every 3 week), combined with endocrine therapy until disease progression, or intolerable toxicity, or withdrawal of informed consent, or discontinuation of medication at the investigator 's discretion. On-study imaging assessments were performed according to RECIST 1.1 criteria and the site assessment was final.

Being tested
CDK4/6 inhibitor (Qilu),Trastuzumab (Hanquyou)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CDK4/6 inhibitor (Qilu),Trastuzumab (Hanquyou)Drug

    Also called Pertuzumab,Letrozole,exemestane

    CDK4/6 inhibitor (Qilu) have got the cFDA approval and Trastuzumab (Hanquyou) have few data on combination use, this two drugs need clinical treatment data

Study groups in NCT05969184
Study groupRoleWhat they receive
four-drug treatment groupExperimentalCDK4/6 inhibitor (Qilu): 125mg, oral Qd from the 1st to the 21st day of the 28 day cycle Trastuzumab (Hanquyou): on the first day of the 21 day cycle, the initial dose was 8mg/kg, and the intravenous infusion was 90 minutes; Every 3 weeks thereafter, the dose is 6mg/kg, and the intravenous infusion is 30~90 minutes Pertuzumab: on the first day of the 21 day cycle, the initial dose was 840mg, intravenous infusion was 60 minutes, and then once every 3 weeks, the dose was 420mg, and the infusion time was 30-60 minutes. Letrozole selected by the doctor: 2.5mg, oral Q24H or exemestane from the 1st to the 21st day of the 21 day cycle: 25mg, oral Q24H from the 1st to the 21st day of the 21 day cycle. The efficacy is evaluated every 2 months (CR, PR, SD, PD).
Receives: Drug: CDK4/6 inhibitor (Qilu),Trastuzumab (Hanquyou)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival(PFS)

    calculated from the first administration time of the study drug to the disease progress or death. If the patient does not have PD or death on the study deadline, or has received other anti-tumor treatment, the deadline shall be the last efficacy evaluation result before the deadline or the start date of other anti-tumor treatment (whichever occurs first)

    Measured: 2 year

Secondary outcomes (5)

  1. Objective response rate (ORR)

    it refers to the proportion of patients who have the best response effect of CR or PR from the beginning of receiving the treatment plan of this study to the time when the patient's disease progresses out of the group. Tumor imaging examination shall be performed at baseline and every 2 cycles (6 weeks) thereafter. If the patient reaches CR or PR, it shall be confirmed after 6 weeks. If patients delay treatment due to toxicity, they still need to receive efficacy evaluation every 6 weeks.

    Measured: 2 year

  2. Disease control rate (DCR)

    refers to the proportion of patients who have achieved complete remission (CR), partial remission (PR) or stable disease (SD) at least once after receiving the treatment of this study protocol

    Measured: 2 year

  3. Duration of remission (DoR)

    from the date when CR or PR evidence was first found to the date when objective progress occurred or the date of death due to any reason, whichever is earlier. If the patient does not know whether the patient is PD or dead at the deadline of the study, the date of the last complete objective progression free disease assessment shall be taken as the data deletion.

    Measured: 2 year

  4. Total survival (OS)

    calculated from the first administration of the study drug to the death due to any reason.The OS of patients who still survived at the last follow-up is counted as the data deletion based on the time of the last follow-up. For patients who lost the interview, their OS was counted as data deletion based on the last confirmed survival time before the lost interview. The OS of data deletion is defined as the time from grouping to deletion

    Measured: 2 year

  5. time to treatment failure(TTF)

    calculated from enrolled in the study to stop treatment resulted in any reason

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2023
  2. Study start12 Dec 2021
  3. Primary completion25 Apr 2026
  4. Study completion25 Jun 2026

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05969184
Sponsor's protocol ID
CABC015
Status last verified
Jun 2025
First submitted
14 Dec 2022
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: research plan would be share after completion of patients enroment.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CDK4/6 inhibitor (Qilu),Trastuzumab (Hanquyou) in people with Breast Neoplasm Female, run by Peking University Cancer Hospital & Institute at 2 sites in China.

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 11 inclusion and 6 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: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival(PFS) (time frame: 2 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05969184.

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 15 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT05969184 | AzTrials