Breast Neoplasm Female
Conditions
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.
Interventions
DRUGTrastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy
Trastuzumab (8-6mg/3weekly)，Pyrotinib（320mg/day）Dalpiciclib（125mg/day，With three weeks separated by one week）
Sponsors
Peking University Cancer Hospital & Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ORR | 8week |
Contacts
Primary ContactGUOHONG SONG
Outcome results
None listed