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Trial Title:
Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy for HR +/HER2 + Advanced Breast Cancer
NCT ID:
NCT05577442
Condition:
Breast Neoplasm Female
Conditions: Official terms:
Breast Neoplasms
Trastuzumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy
Description:
Trastuzumab (8-6mg/3weekly)，Pyrotinib（320mg/day）Dalpiciclib（125mg/day，With three weeks
separated by one week）
Arm group label:
Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy
Other name:
Trastuzumab Pyrotinib Dalpiciclib
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
October 20, 2022
Completion date:
October 20, 2024
Lead sponsor:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Peking University Cancer Hospital & Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05577442
