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Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery
Led by University of Chicago · Updated on 2026-02-17
74
Participants Needed
4
Research Sites
589 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery.
CONDITIONS
Official Title
Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 70 years
- Breast tumor accessible for biopsy and measurable by ultrasound at least 2 cm in size
- Histologically confirmed female breast carcinoma with positive HER2 status
- Clinical cancer stages 2A to 3C (AJCC 2009)
- No prior chemotherapy for this breast cancer
- Eastern Cooperative Oncology Group performance status between 0 and 3
- Non-pregnant and not nursing; women able to take pregnancy test and commit to hormone therapy with goserelin for two years starting with study medications
- Adequate blood counts, kidney and liver function as defined by specific laboratory values
- Baseline heart function with left ventricular ejection fraction of 55% or higher
You will not qualify if you...
- Pregnant or breastfeeding women; women of childbearing potential not using reliable contraception
- Presence of distant metastasis
- Serious or uncontrolled infections
- More than 4 weeks of prior tamoxifen therapy for this cancer
- Treatment for other cancers within the last 5 years except certain skin and cervical cancers
- Participation in any investigational drug study within 4 weeks before starting treatment
- Other serious uncontrolled medical conditions such as HIV, uncontrolled hypertension, heart failure, or psychiatric illness that may affect study participation
- Unwillingness or inability to comply with study protocol
- HER2-negative breast cancer
- History of heart failure, significant arrhythmias, angina needing medication, valvular heart disease
- Poorly controlled high blood pressure (systolic > 180 mm Hg or diastolic > 100 mm Hg)
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Lagos State University Teaching Hospital
Ikeja, Lagos, Nigeria, 100271
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2
Lagos University Teaching Hospital
Yaba, Lagos, Nigeria, 100254
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3
Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC)
Ile-Ife, Osun State, Nigeria, 220005
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4
University of Ibadan Hospital
Ibadan, Oyo State, Nigeria, 200285
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Research Team
O
Olufunmilayo Olopade
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
3
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