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

NCT ID: NCT05577442

Last Updated: 2022-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-20
• Study Completion Date: 2024-10-20

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.

Conditions

Breast Neoplasm Female

Study Design

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

Study Groups

Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy

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.

Group Type: EXPERIMENTAL

Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy

Intervention Type: DRUG

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

Interventions

Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy

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

Intervention Type: DRUG

Other Intervention Names

Trastuzumab Pyrotinib Dalpiciclib

Eligibility Criteria

Inclusion Criteria

1. Female breast cancer patients of any menopausal status aged 18-75 years.

2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.

3. 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.

4. 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 +.

5. measurable lesions by RECIST 1.1 criteria.

6. 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;

7. Stable patients with brain metastases are allowed.

8. life expectancy ≥ 12 weeks.

9. adequate organ and bone marrow function.

10. adequate cardiac reserve, left ventricular ejection fraction (LVEF) ≥ 45% on echocardiogram.

Exclusion Criteria

1. 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).

2. previous treatment with CDK4/6 inhibitors.

3. previous treatment with TKI.

4. visceral crisis.

5. Major surgery, chemotherapy, radiation therapy, any investigational agent, or other anticancer therapy within 2 weeks before entering the study.

6. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 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

Central Contacts

GUOHONG SONG

Role: CONTACT

songguohong918@hotmail.com

13911263305

Other Identifiers

OBU-BC-Ⅱ-077

Identifier Type: -

Identifier Source: org_study_id