Status:
UNKNOWN
The Combination of Palbociclib With ddEC-P as Neoadjuvant Therapy in Triple Negative Breast Cancer
Lead Sponsor:
Zhejiang Cancer Hospital
Conditions:
Breast Cancer
Breast Diseases
Eligibility:
FEMALE
18-80 years
Phase:
NA
Brief Summary
This study will look at effects the combination of palbociclib and dose-dense neoadjuvant chemotherapy may have on triple negative breast cancer tumours which have not yet been treated.
Detailed Description
Patients will be randomized to one of two treatment arms (1:1 ratio). Dose-Dense neoadjuvant chemotherapy in the first 8 weeks of will be: epirubicin (90mg/m2) and cyclophosphamide (600mg/m2), followe...
Eligibility Criteria
Inclusion
- female patients, 18 years ≤ age ≤ 80 years；
- Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- Histologically confirmed invasive breast cancer（early stage or locally advanced）
- HER2 negative (HER2+/- by IHC or FISH-)
- Hormone receptor (ER and PR) negative
- Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO
- Signed informed consent form (ICF)
Exclusion
- Metastatic disease (Stage IV) or inflammatory breast cancer
- Previous or current history of malignant neoplasms, except for curatively treated: Basal and squamous cell carcinoma of the skin, Carcinoma in situ of the cervix.
- Clinically relevant cardiovascular disease: Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
- Unable or unwilling to swallow capsules.
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2020
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03756090
Start Date
December 1 2018
End Date
November 30 2020
Last Update
December 7 2018
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