MicroRNA and circulating tumor DNA monitoring during chemotherapy for triple negative breast cancer

Treatment Response and microRNA Profiles in Triple Negative Breast Cancer Patients Receiving Standard Chemotherapy

This trial will test whether changes in blood microRNA and circulating tumor DNA can show early chemotherapy failure in women with triple negative breast cancer receiving epirubicin–cyclophosphamide followed by paclitaxel–carboplatin.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: University College Hospital, Ibadan (Academic / other)
• Drugs / interventions: Chemotherapy, Cyclophosphamide
• Locations: 4 sites (Ile-Ife, Oshun and 3 other locations)
• Trial ID: NCT04771871 on ClinicalTrials.gov

What this trial studies

This is a single-arm Phase 2 trial enrolling 42 chemotherapy-naïve Nigerian women with biopsy-confirmed triple negative breast cancer (clinical stages IIA–IIIC). Participants receive a standard epirubicin and cyclophosphamide regimen followed by paclitaxel plus carboplatin while researchers collect blood samples before, during, and after treatment. Blood levels of microRNA molecules and circulating tumor DNA will be measured and correlated with imaging-based tumor response by ultrasound using standard response criteria. The study aims to determine the response rate to the regimen and whether circulating markers can serve as early indicators of treatment resistance.

Who should consider this trial

Good fit: Ideal candidates are chemotherapy‑naïve women aged 18–70 with biopsy‑confirmed triple negative breast cancer, measurable disease (≥2 cm), clinical stage IIA–IIIC, and ECOG performance status 0–1.

Not a fit: Patients with other breast cancer subtypes, prior systemic chemotherapy for this malignancy, poor performance status, metastatic disease outside the eligible stages, pregnant or nursing women are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the approach could provide a simple blood test to detect chemotherapy resistance earlier and help guide treatment changes for women with TNBC.

How similar studies have performed: Prior research has shown promising but still preliminary results for circulating microRNA and circulating tumor DNA as biomarkers in breast cancer, though these markers are not yet established for routine clinical use.

Eligibility criteria

Inclusion Criteria:

1. Women ages of 18 to 70 years old
2. Women who give informed consent for the study
3. Biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm)
4. Patients with histologically confirmed carcinoma of the female breast with triple negative status by immuno-histochemistry (IHC)
5. Clinical stages IIA -IIIC (AJCC 2009)
6. Chemotherapy-naïve patients (for this malignancy)
7. Performance status: Eastern Cooperative Oncology Group (ECOG) performance status 0-1
8. 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
9. 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%

Exclusion Criteria:

1. 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.
2. Patients with distant metastasis (brain and/or visceral metastasis)
3. Serious, uncontrolled, concurrent infection(s).
4. Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)
5. Participation in any investigational drug study within 4 weeks preceding the start of study treatment
6. 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.

Where this trial is running

Ile-Ife, Oshun and 3 other locations

• Obafemi Awolowo University Teaching Hospital — Ile-Ife, Oshun, Nigeria (Not_yet_recruiting)
• University College Hospital — Ibadan, Oyo State, Nigeria (Recruiting)
• Lagos State University Teaching Hospital — Lagos, Nigeria (Not_yet_recruiting)
• Lagos University Teaching Hospital — Lagos, Nigeria (Not_yet_recruiting)

Study contacts

• Principal investigator: Atara Ntekim — University of Ibadan
• Study coordinator: Tonyin Aniagwu

Conditions Triple Negative Breast Cancer; Breast cancer; neoadjuvant treatment; microRNA; circulating tumor cells