Actively Recruiting
Markers to Evaluate the Efficacy of PH-based Regimen as a Neoadjuvant Therapy for Operable HER2 Positive Breast Cancer
Led by Fudan University · Updated on 2020-05-04
94
Participants Needed
1
Research Sites
523 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is to explore the markers in early prediction of the efficacy of pre-operative pertuzumab plus trastuzumab (PH) combined with chemotherapy for early stage or locally advanced human epidermal growth factor receptor-2 (HER-2) positive primary breast cancer.
CONDITIONS
Official Title
Markers to Evaluate the Efficacy of PH-based Regimen as a Neoadjuvant Therapy for Operable HER2 Positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male with operable breast cancer, no prior treatment for invasive cancer
- Primary tumor larger than 2 cm in diameter
- Age 18 years or older and under 70 years
- ECOG performance status of 0 or 1
- Left ventricular ejection fraction (LVEF) 55% or higher at baseline
- Tumor tissue specimen available after surgery
- Agree to core needle biopsy for genomic and drug sensitivity testing
- Histologically confirmed breast cancer diagnosis
- HER2-positive disease by immunohistochemistry (3+) or HER2 amplification by FISH
- Hormone receptor status (ER and PgR) assessed
- Signed informed consent
- Able to follow study protocol
You will not qualify if you...
- Metastatic (Stage IV) or bilateral breast cancer
- Previous systemic therapy or radiation for cancer
- Prior malignancy within 5 years before study entry
- Inadequate bone marrow, kidney, or liver function
- History or signs of cardiovascular disease
- Severe uncontrolled systemic illness
- Poorly controlled diabetes or diabetic vascular complications
- Pregnant or breastfeeding women
- Received investigational treatment within 4 weeks before study
- Known HIV, hepatitis B, or hepatitis C infection
- Daily corticosteroid treatment over 10 mg methylprednisolone equivalent (except inhaled steroids)
- Known allergy to study drugs or their ingredients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai Cancer Center, Fudan University
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
J
Jiong Wu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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