Blood test may predict chemo failure in aggressive breast cancer
NCT ID NCT04771871
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at how well standard chemotherapy works in people with triple-negative breast cancer, an aggressive type that lacks targeted treatments. Researchers will also measure tiny molecules called microRNAs and tumor DNA in the blood to see if changes can signal when the drugs stop working. The goal is to find a simple blood test that helps doctors adjust treatment early.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Epirubicin, Cyclophosphamide, Paclitaxel, Carboplatin (chemotherapy drugs)
- What this could lead to
- If successful, this could lead to a simple blood test that tells doctors early when chemotherapy is not working, allowing them to switch treatments sooner.
- What could go wrong
- This is a small, early-phase study with only 42 people. The blood test idea is still experimental and may not prove reliable enough for routine use.
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 42 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2021
- Expected to finish
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Aug 2030
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 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.
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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
NOT_YET_RECRUITINGLagos, Nigeria
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Lagos University Teaching Hospital
NOT_YET_RECRUITINGLagos, Nigeria
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Obafemi Awolowo University Teaching Hospital
NOT_YET_RECRUITINGIle-Ife, Oshun, Nigeria
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University College Hospital
RECRUITINGIbadan, Oyo State, 200221, Nigeria
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Other studies related to the condition(s) this trial covers.
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