Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer
NCT ID: NCT04997798
Last Updated: 2023-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2022-09-01
2024-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Dalpiciclib in combination with exemestane and trastuzumab plus pyrotinib
Patients are treated with intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg, Q3W) for six cycles plus oral Dalpiciclib (125 mg QD x 21，Q4W) and Exemestane (25 mg po QD ）and oral pyrotinib (320 mg po QD) for 20 weeks.
Trastuzumab Pyrotinib Exemestane Dalpiciclib
Early triple positive breast cancer patients receive combination regimen of Dalpiciclib in Combination With Exemestane and Trastuzumab plus pyrotinib
Interventions
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Trastuzumab Pyrotinib Exemestane Dalpiciclib
Early triple positive breast cancer patients receive combination regimen of Dalpiciclib in Combination With Exemestane and Trastuzumab plus pyrotinib
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed clinical stage II or III ER+/HER2+ breast cancer, staging criteria is to be based on AJCC 7.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Primary tumor must have positive estrogen receptor (ER) ≥10%
* Primary tumor must be HER2-positive (IHC 3+ or FISH/CISH amplification)
* Baseline LVEF ≥50% measured by Echocardiography (preferred) or MUGA scan
* Normal organ and marrow function
* Written Informed Consent (IC) must be signed and dated by the patient and the Investigator prior to randomization.
* Baseline corrected QT interval (QTcF) \< 480 ms
* All patients must be female.
Exclusion Criteria
* Evidence of bilateral invasive breast cancer or metastatic disease
* Received any prior treatment for primary invasive breast cancer
* Pregnant or lactating women
* Abnormal baseline hematological values:
* Abnormal baseline liver function, bilirubin, creatinine and/or INR (international normalized ratio)
* Subjects with known infection with HIV, HBV, HCV
* Other investigational drugs while on study
* Severe or uncontrolled hypertension, history of congestive heart failure or severe coronary arterial disease.
* Subjects assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
18 Years
75 Years
FEMALE
No
Sponsors
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First Affiliated Hospital of Zhejiang University
OTHER
Responsible Party
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Principal Investigators
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Peifen Fu, Doctor
Role: PRINCIPAL_INVESTIGATOR
Zhejiang University
Locations
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The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Luyan Chen, Doctor
Role: CONTACT
Facility Contacts
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Jiaqi Jiang
Role: primary
Other Identifiers
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ZYYY-BC-001
Identifier Type: -
Identifier Source: org_study_id
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