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

• Status: Not yet recruiting
• Trial end date: 2024-10-20
• Target enrollment: 0
• Participant gender: Female

Summary

In this study, we investigate the efficacy and safety of trastuzumab, pyrotinib combined with dalpiciclib and endocrine combination therapy for patients with advanced HR+/HER2+, providing more possible effective regimens for the survival benefit of these patients in clinical practice.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University Cancer Hospital & Institute
• Treatments: Trastuzumab

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.