Overview

Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy

Status:
Terminated
Trial end date:
2015-11-01
Target enrollment:
0
Participant gender:
All
Summary
Hormonal therapy administered before surgery in ER-positive and HER2-positive patients with breast cancer.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Western Regional Medical Center
Treatments:
Docetaxel
Fulvestrant
Pertuzumab
Trastuzumab
Criteria
Inclusion Criteria:

1. Patients ≥ 18 years of age with histologically, and radiographically confirmed
non-metastatic ER-positive (defined as ≥30% of positive cells) and HER2-positive
(defined as overexpression by immunohistochemistry (3+) or 2+ and positive by defined
by fluorescence or dual in situ hybridization.) breast cancer with minimal tumor size
over 2 cm (≥T2 lesion) to receive neoadjuvant chemotherapy recommended by the treating
physician

2. Eastern Cooperative Oncology Group (ECOG) performance status score < 1

3. Absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5
g/dL

4. Serum creatinine ≤1.5 times the upper limit of the normal range, total bilirubin ≤ 1.5
X ULN (≤ 3 mg/dL if clinically diagnosed with Gilbert syndrome) AST/ALT ≤ 2.5 X ULN
(AST/ALT ≤ 5X ULN if clinically diagnosed with Gilbert syndrome)

5. Women of child-bearing potential (i.e., women who are pre-menoposaul or not surgically
sterile) must have a negative serum pregnancy test within 2 weeks prior to beginning
treatment

Exclusion Criteria:

1. Uncontrolled cardiac disease, such as angina, hypertension or significant arrhythmias

2. LVEF (left ventricular ejection fraction) < 50% on any prior assessment. Note:
Assessment of LVEF is done before and after trastuzumab-based chemotherapy as standard
of care

3. Pregnant or lactating females

4. Inability to complete informed consent process and adhere to the protocol treatment
plan and follow-up requirements

5. Concurrent severe illness such as active infection, or psychiatric illness/social
situations that would limit safety and compliance with study requirements