NCT04771871RecruitingPhase 2
MicroRNA Profiles in Triple Negative Breast Cancer
Treatment Response and microRNA Profiles in Triple Negative Breast Cancer Patients Receiving Standard Chemotherapy
Source: ClinicalTrials.gov · Last updated 7 May 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- First submitted
- 14 Feb 2021
- Start date
- 29 Nov 2021
- Primary completion date
- Mar 2027
- Lead sponsor
- University College Hospital, Ibadan
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT04771871
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 42
- From 29 Nov 2021 to the primary completion date, Mar 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Serious, uncontrolled, concurrent infection(s).
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment
Other illness
- Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)
- Other serious uncontrolled medical conditions that the investigator feels might compromise study participation including but not limited to chronic or active infection, HIV-positive patient, uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled Diabetes mellitus, or psychiatric illness/social situations that would limit compliance with study requirements.
Other
- Pregnant or lactating women. Women of childbearing potential not using a reliable and appropriate contraceptive method. Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.
- Patients with distant metastasis (brain and/or visceral metastasis)
Who the study is looking for
- Women ages of 18 to 70 years old
- Women who give informed consent for the study
- Biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm)
- Patients with histologically confirmed carcinoma of the female breast with triple negative status by immuno-histochemistry (IHC)
- Clinical stages IIA -IIIC (AJCC 2009)
- Chemotherapy-naïve patients (for this malignancy)
- Performance status: Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Non-pregnant and not nursing. Women of childbearing potential must take the pregnancy test and must commit to receive Leuteinizing Hormone Realising Hormone (LHRH) agonist Zoladex (goserelin) for two years starting from the commencement of the study medications
- Required Initial Laboratory Data. Adequate hematologic, renal and hepatic function, as defined by each of the following:
- 1\. Granulocyte ≥ 1,500/μL 2. Platelet count ≥ 100,000/μL 3. Absolute neutrophil count (ANC) ≥ l500/μL 4. Hemoglobin ≥ 10g/dL 5. Bilirubin ≤ 1.5 x upper limit of normal 6. SGOT and SGPT \< 2.5 x upper limit of normal 7. Creatinine within institutional normal limits or glomerular filtration rate ≥ 30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) (CKD EPI) equation (see http://mdrd.com/ for calculator) 10. Echocardiogram (ECHO): Baseline left ventricular ejection fraction of ≥ 55%
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University College Hospital Coordinator of this site? Confirm its status | Ibadan | Nigeria | Recruiting |
| Obafemi Awolowo University Teaching Hospital Coordinator of this site? Confirm its status | Ile-Ife | Nigeria | Not yet recruiting |
| Lagos University Teaching Hospital Coordinator of this site? Confirm its status | Lagos | Nigeria | Not yet recruiting |
| Lagos State University Teaching Hospital Coordinator of this site? Confirm its status | Lagos | Nigeria | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.