The Combination of Palbociclib With ddEC-P as Neoadjuvant Therapy in Triple Negative Breast Cancer

• Status: Unknown status
• Trial end date: 2020-11-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Zhejiang Cancer Hospital
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Epirubicin; Paclitaxel; Palbociclib

Criteria

Inclusion Criteria:

1. female patients, 18 years ≤ age ≤ 80 years；

2. Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1

3. Histologically confirmed invasive breast cancer（early stage or locally advanced）

4. HER2 negative (HER2+/- by IHC or FISH-)

5. Hormone receptor (ER and PR) negative

6. Cardiovascular: Baseline left ventricular ejection fraction (LVEF)≥55% measured by ECHO

7. Signed informed consent form (ICF)

Exclusion Criteria:

1. Metastatic disease (Stage IV) or inflammatory breast cancer

2. 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.

3. Clinically relevant cardiovascular disease: Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);

4. Unable or unwilling to swallow capsules.