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Blood test may predict chemo failure in aggressive breast cancer

NCT ID NCT04771871

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2021

Expected to finish

Aug 2030

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

Sex

Female participants only

Healthy volunteers

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

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.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Lagos State University Teaching Hospital

    NOT_YET_RECRUITING

    Lagos, Nigeria

  • Lagos University Teaching Hospital

    NOT_YET_RECRUITING

    Lagos, Nigeria

  • Obafemi Awolowo University Teaching Hospital

    NOT_YET_RECRUITING

    Ile-Ife, Oshun, Nigeria

  • University College Hospital

    RECRUITING

    Ibadan, Oyo State, 200221, Nigeria

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