Neoadjuvant Hormonal Therapy Combined With Chemoimmunotherapy
Stopped early · Phase 1/Phase 2
Conditions studied: HER2-positive Breast Cancer, ER-positive Breast Cancer
In brief
Hormonal therapy administered before surgery in ER-positive and HER2-positive patients with breast cancer.
Key facts
- Study ID
- NCT02345772
- Run by
- Western Regional Medical Center
- People needed
- 4
- Starts
- 2014-07-01
- Expected to finish
- 2015-11-01
- Last updated by the study team
- 2018-02-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Eastern Cooperative Oncology Group (ECOG) performance status score < 1
- Absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5 g/dL
- 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)
- 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
You may not qualify if…
- Uncontrolled cardiac disease, such as angina, hypertension or significant arrhythmias
- 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
- Pregnant or lactating females
- Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
- Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements
Where it is running
- Western Regional Medical Center, Inc. — Goodyear, Arizona, United States
Full record on ClinicalTrials.gov
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