Actively Recruiting
MicroRNA Profiles in Triple Negative Breast Cancer
Led by University College Hospital, Ibadan · Updated on 2026-05-07
42
Participants Needed
4
Research Sites
452 weeks
Total Duration
On this page
Sponsors
U
University College Hospital, Ibadan
Lead Sponsor
L
Lagos State University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Triple negative breast cancer (TNBC) is an aggressive disease with higher proportion of Blacks affected and in younger age groups. There is no targeted therapy unlike other types of breast cancer such as hormone positive and Human Epidermal Growth factor 2 (HER2) positive subtypes. Chemotherapy is therefore the main choice of systemic treatment with rapid development of resistance in most cases. At present, there is no blood test to monitor treatment response and disease relapse. This one-stage phase II study with a single arm design will determine the response rate of standard chemotherapy using Epirubicin (60mg/m2), Cyclophosphamide (600mg/m2) , Paclitaxel (120mg/m2) and Carboplatin (6AUC) in TNBC patients. We will measure the blood level of microRNA molecules and circulating tumor DNA during and after treatment to test if changes can be used to indicate drug failure in these patients. Disease status and tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines while toxicity will be assessed using CTCAE v5). The trial will be conducted as per the International Council on Harmonisation Good Clinical Practice (ICH GCP) Guidelines E6 (R1) and other applicable guidelines
CONDITIONS
Official Title
MicroRNA Profiles in Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 70 years old
- Women who provide informed consent for the study
- Breast tumor accessible for biopsy or measurable by ultrasound, at least 2 cm in size
- Histologically confirmed triple negative breast cancer by immunohistochemistry
- Clinical stages IIA to IIIC according to AJCC 2009
- Patients who have not received chemotherapy for this cancer
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Not pregnant or nursing; women of childbearing potential must take a pregnancy test and agree to receive LHRH agonist (Zoladex) for two years starting with study treatment
- Adequate blood counts, liver and kidney function as defined by specific laboratory values
- Baseline heart function with left ventricular ejection fraction of at least 55% by echocardiogram
You will not qualify if you...
- Pregnant or breastfeeding women
- Women of childbearing potential not using reliable contraception
- Postmenopausal women who have not been amenorrheic for at least 12 months
- Presence of distant metastasis including brain or visceral metastases
- Serious uncontrolled infections
- Treatment for other cancers within the last 5 years except treated non-melanoma skin cancer or cervical carcinoma in situ
- Participation in another investigational drug study within 4 weeks before starting treatment
- Serious uncontrolled medical conditions that may affect participation, such as HIV, uncontrolled hypertension, symptomatic heart failure, unstable angina, uncontrolled diabetes, or psychiatric/social issues limiting compliance
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Obafemi Awolowo University Teaching Hospital
Ile-Ife, Oshun, Nigeria
Not Yet Recruiting
2
University College Hospital
Ibadan, Oyo State, Nigeria, 200221
Actively Recruiting
3
Lagos State University Teaching Hospital
Lagos, Nigeria
Not Yet Recruiting
4
Lagos University Teaching Hospital
Lagos, Nigeria
Not Yet Recruiting
Research Team
T
Tonyin Aniagwu
CONTACT
A
Abiodun Oni
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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