Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT06348134

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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

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Trial Site Locations

Total: 4 locations

1

Lagos State University Teaching Hospital

Ikeja, Lagos, Nigeria, 100271

Actively Recruiting

2

Lagos University Teaching Hospital

Yaba, Lagos, Nigeria, 100254

Actively Recruiting

3

Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC)

Ile-Ife, Osun State, Nigeria, 220005

Actively Recruiting

4

University of Ibadan Hospital

Ibadan, Oyo State, Nigeria, 200285

Actively Recruiting

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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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