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Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy for HR +/HER2 + Advanced Breast Cancer

Primary Purpose

Breast Neoplasm Female

Status

Not yet recruiting

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy

About this trial

This is an interventional treatment trial for Breast Neoplasm Female

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Female breast cancer patients of any menopausal status aged 18-75 years.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
Female breast cancer patients with HER2-positive HR-positive of recurrence or metastasis and are not suitable for surgical resection or radiation therapy with the purpose of cure.
ER and/or PR +: defined as positively stained tumor cells representing ≥ 10% of all tumor cells (confirmed by investigator review at the site) and HER2 +: defined as IHC 3 + or IHC 2 + and FISH +/CISH +.
measurable lesions by RECIST 1.1 criteria.
Patients' previous treatment should meet: a) prior systemic (neo) adjuvant therapy is allowed but not required, and if received, the disease-free interval (DFI) must be > 24 months (DFI is defined as the time from surgery to the first recurrence); b) ≤ 1 line of systemic therapy for the tumor (including anti-HER2 targeted therapy, endocrine therapy and chemotherapy) is received at the metastatic stage;
Stable patients with brain metastases are allowed.
life expectancy ≥ 12 weeks.
adequate organ and bone marrow function.
adequate cardiac reserve, left ventricular ejection fraction (LVEF) ≥ 45% on echocardiogram.

Exclusion Criteria:

patients who are not suitable for endocrine therapy as judged by the investigator. Including symptomatic, advanced patients with disseminated visceral disease who are at short-term risk of life-threatening complications (including patients with uncontrolled large exudates [pleural, pericardial, abdominal], pulmonary lymphangitis and more than 50% hepatic involvement).
previous treatment with CDK4/6 inhibitors.
previous treatment with TKI.
visceral crisis.
Major surgery, chemotherapy, radiation therapy, any investigational agent, or other anticancer therapy within 2 weeks before entering the study.
Have been diagnosed with any other malignancy within 3 years before entering the study, except for curatively treated non-melanoma skin cancer, basal cell or squamous cell skin cancer, or cervical carcinoma in situ.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy

Arm Description

for the HR+/HER2+MBC will be treated with Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy. Endocrine drug be determined by physician depend on the history.

Outcomes

Primary Outcome Measures

ORR

Secondary Outcome Measures

Full Information

NCT ID

NCT05577442

First Posted

October 9, 2022

Last Updated

October 17, 2022

Sponsor

Peking University Cancer Hospital & Institute

1. Study Identification

Unique Protocol Identification Number

NCT05577442

Brief Title

Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy for HR +/HER2 + Advanced Breast Cancer

Official Title

Peking University Cancer Hospital & Institute

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

October 20, 2022 (Anticipated)

Primary Completion Date

October 20, 2023 (Anticipated)

Study Completion Date

October 20, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking University Cancer Hospital & Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study investigates the efficacy and safety of trastuzumab, pyrotinib combined with dalpiciclib and endocrine therapy for patients with advanced HR+/HER2+ brest cancer, providing more possible effective regimens for the survival benefit of these patients in clinical practice.

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 pyrotinib（320mg/day), trastuzumab(8 mg→6mg/every 3 week), dalpiciclib(125mg once daily for 3 weeks, followed by 1 week off in each 4-week cycle), 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasm Female

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy

Arm Type

Experimental

Arm Description

for the HR+/HER2+MBC will be treated with Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy. Endocrine drug be determined by physician depend on the history.

Intervention Type

Drug

Intervention Name(s)

Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy

Other Intervention Name(s)

Trastuzumab Pyrotinib Dalpiciclib

Intervention Description

Trastuzumab (8-6mg/3weekly)，Pyrotinib（320mg/day）Dalpiciclib（125mg/day，With three weeks separated by one week）

Primary Outcome Measure Information:

Title

ORR

Time Frame

8week

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female breast cancer patients of any menopausal status aged 18-75 years. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. Female breast cancer patients with HER2-positive HR-positive of recurrence or metastasis and are not suitable for surgical resection or radiation therapy with the purpose of cure. ER and/or PR +: defined as positively stained tumor cells representing ≥ 10% of all tumor cells (confirmed by investigator review at the site) and HER2 +: defined as IHC 3 + or IHC 2 + and FISH +/CISH +. measurable lesions by RECIST 1.1 criteria. Patients' previous treatment should meet: a) prior systemic (neo) adjuvant therapy is allowed but not required, and if received, the disease-free interval (DFI) must be > 24 months (DFI is defined as the time from surgery to the first recurrence); b) ≤ 1 line of systemic therapy for the tumor (including anti-HER2 targeted therapy, endocrine therapy and chemotherapy) is received at the metastatic stage; Stable patients with brain metastases are allowed. life expectancy ≥ 12 weeks. adequate organ and bone marrow function. adequate cardiac reserve, left ventricular ejection fraction (LVEF) ≥ 45% on echocardiogram. Exclusion Criteria: patients who are not suitable for endocrine therapy as judged by the investigator. Including symptomatic, advanced patients with disseminated visceral disease who are at short-term risk of life-threatening complications (including patients with uncontrolled large exudates [pleural, pericardial, abdominal], pulmonary lymphangitis and more than 50% hepatic involvement). previous treatment with CDK4/6 inhibitors. previous treatment with TKI. visceral crisis. Major surgery, chemotherapy, radiation therapy, any investigational agent, or other anticancer therapy within 2 weeks before entering the study. Have been diagnosed with any other malignancy within 3 years before entering the study, except for curatively treated non-melanoma skin cancer, basal cell or squamous cell skin cancer, or cervical carcinoma in situ.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

GUOHONG SONG

Phone

13911263305

songguohong918@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy for HR +/HER2 + Advanced Breast Cancer

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