Palbociclib Combine With Anti-HER2 Therapy in Triple Positive ABC

NCT ID: NCT05969184

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-25
• Study Completion Date: 2024-12-25

Brief 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.

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.

Conditions

Breast Neoplasm Female

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

four-drug treatment group

CDK4/6 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).

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

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

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

Intervention Type: DRUG

Other Intervention Names

Pertuzumab,Letrozole,exemestane

Eligibility Criteria

Inclusion Criteria

• 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.
• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: lead

Responsible Party

Li Huiping

Head of the department of breast oncology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yaxin Liu, Dr

Role: STUDY_CHAIR

Peking University Cancer Hospital and Institute

Locations

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status: ACTIVE_NOT_RECRUITING

Yaxin Liu

Beijing, None Selected, China

Site Status: RECRUITING

Countries

China

Central Contacts

Huiping Li, Dr

Role: CONTACT

huipingli2012@hotmail.com

01088196380

Yaxin Liu, Dr

Role: CONTACT

liuyaxin0625@126.com

01088196380

Facility Contacts

Yaxin Liu

Role: primary

liuyaxin0625@126.com

01088196380

Other Identifiers

CABC015

Identifier Type: -

Identifier Source: org_study_id