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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University College Hospital
  Ibadan, Oyo State, Nigeria Recruiting
• Obafemi Awolowo University Teaching Hospital
  Ile-Ife, Oshun, Nigeria Not yet 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
• Email: taniagwu@yahoo.com
• Phone: 234-8033535370

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.