Phase II Open-label, Multicentre, Exploratory Trial of Neoadjuvant Dalpiciclib in Combination With Exemestane and Trastuzumab Plus Pyrotinib in Early Triple Positive Breast Cancer

ZYYY-BC-001

This is a phase II open-label, multicenter trial assessing the efficacy of combination regimen"Dalpiciclib plus Exemestane plus trastuzumab plus pyrotinib"in early triple positive breast cancer patients.

2022-09-01

2024-12-01

2024-12-01

Recruiting

Early phase I

30

Inclusion Criteria: * 18 Years to 75 Years * 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: * Inflammatory breast cancer * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

2023-02-21