New study aims to wipe out aggressive breast cancer before surgery
NCT ID NCT06291064
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a specific chemotherapy combination (epirubicin + cyclophosphamide followed by docetaxel + carboplatin) in 85 Nigerian women with triple-negative breast cancer. The main goal is to see how many women have no cancer left in their breast or lymph nodes after treatment, before surgery. Researchers will also look for blood markers that might show if the cancer is resistant to chemotherapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 85 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2025
- Expected to finish
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Jun 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Women ages of 18 to 70 years old 2. Women who are able and willing to read understand and sign an informed consent document 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 immunohistochemistry (IHC). Patients who are low estrogen reception (ER) expression (\< 20%), progesterone receptor (PR) negative and human epidermal growth factor 2 (HER2) negative are eligible. 5. Clinical stages IIA -IIIC (AJCC 2009) 6. Chemotherapy-naïve patients (for this cancer) 7. Performance status: Eastern Cooperative Oncology Group (ECOG) performance status 0-1 8. Non-pregnant and not nursing. * Granulocyte greater than or equal to 1,500/microliter * Platelet count greater than or equal to 100,000/microliter * Absolute neutrophil count (ANC) greater than or equal to l500/microliter * Hemoglobin greater than or equal to 10g/deciliter * Bilirubin less than or equal 1.5 x upper limit of normal * aspartate aminotransferase (ALT or SGOT) and alanine transaminase (AST or SGPT) less than 2.5 x upper limit of normal 7\. Creatinine within institutional normal limits or glomerular filtration rate greater than or equal to 30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration (CKD EPI) equation 10. Baseline left ventricular ejection fraction of greater than or equal to 55% Exclusion Criteria: 1. Pregnant or lactating women. 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 treating 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Lagos State University Teaching Hospital
RECRUITINGIkeja, Lagos, 100271, Nigeria
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Lagos University Teaching Hospital
RECRUITINGYaba, Lagos, 100254, Nigeria
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Obafemi Awolowo University Teaching Hospitals Complex
RECRUITINGIle-Ife, Osun State, 220005, Nigeria
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University of Ibadan Hospital
RECRUITINGIbadan, Oyo State, 200285, Nigeria
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Other studies related to the condition(s) this trial covers.
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