Triple Negative Breast CancerPhase 2TARMACNCT04771871
MicroRNA Profiles in Triple Negative Breast Cancer
A Phase 2 study testing Epirubicin, Cyclophosphamide and Paclitaxel in people with Triple Negative Breast Cancer, run by University College Hospital, Ibadan at 4 sites in Nigeria.
Trial summary
Triple negative breast cancer (TNBC) is an aggressive disease with higher proportion of Blacks affected and in younger age groups. There is no targeted therapy unlike other types of breast cancer such as hormone positive and Human Epidermal Growth factor 2 (HER2) positive subtypes. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Triple Negative Breast Cancer
- What is being tested?
- Epirubicin, Cyclophosphamide and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 4 sitesNigeria
- Study dates
- 29 Nov 2021to Aug 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women ages of 18 to 70 years old
- Women who give informed consent for the study
- Biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm)
- Patients with histologically confirmed carcinoma of the female breast with triple negative status by immuno-histochemistry (IHC)
- Clinical stages IIA -IIIC (AJCC 2009)
- Chemotherapy-naïve patients (for this malignancy)
Show all 10Show fewer
- Performance status: Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- 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
- 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%
Who cannot join
- 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.
- Patients with distant metastasis (brain and/or visceral metastasis)
- Serious, uncontrolled, concurrent infection(s).
- Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nigeria4 sites, 4 recruiting
- Recruiting
University College Hospital
Ibadan, Oyo State, 200221
Tonyin Aniagwu, RN MPH, 234-8033535370, taniagwu@yahoo.com
Abiodun Oni, BSc, 2348023941587, abiodunoni41@gmail.com
- Not yet recruiting
Obafemi Awolowo University Teaching Hospital
Ile-Ife, Oshun
Ifeoluwa Olagunju, 2347053670305, ifeoluwaolagunju4@gmail.com
Olukayode Arowolo, MD
- Not yet recruiting
Lagos State University Teaching Hospital
Lagos
Stella O Odedina, PhD, 2348035762998, stellakinleye@yahoo.com
Abiodun Popoola, MD
- Not yet recruiting
Lagos University Teaching Hospital
Lagos
Ibidunni Akerele, 2347063727006, ibidunniakerele7@gmail.com
Anthonia Sowunmi, MD
About this study
Official title: Treatment Response and microRNA Profiles in Triple Negative Breast Cancer Patients Receiving Standard Chemotherapy
Triple negative breast cancer (TNBC) is an aggressive disease with higher proportion of Blacks affected and in younger age groups. There is no targeted therapy unlike other types of breast cancer such as hormone positive and Human Epidermal Growth factor 2 (HER2) positive subtypes. Chemotherapy is therefore the main choice of systemic treatment with rapid development of resistance in most cases. At present, there is no blood test to monitor treatment response and disease relapse. This one-stage phase II study with a single arm design will determine the response rate of standard chemotherapy using Epirubicin (60mg/m2), Cyclophosphamide (600mg/m2) , Paclitaxel (120mg/m2) and Carboplatin (6AUC) in TNBC patients. We will measure the blood level of microRNA molecules and circulating tumor DNA during and after treatment to test if changes can be used to indicate drug failure in these patients. Disease status and tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines while toxicity will be assessed using CTCAE v5). The trial will be conducted as per the International Council on Harmonisation Good Clinical Practice (ICH GCP) Guidelines E6 (R1) and other applicable guidelines
Read the detailed description
Triple negative subtype of breast cancer (TNBC), accounts for about 55% of all breast cancer among indigenous blacks, such as Nigerians, and younger women are more susceptible Patients with TNBC generally experience a more aggressive clinical course with faster disease progression and poorer overall survival. There is no targeted treatment available beyond conventional cytotoxic chemotherapy . Unfortunately, standard chemotherapy is only effective in about 40% of patients with pathological complete response (pCR) achieved only in 20%-30% . Local relapse occurs early. Therefore, chemo-resistance is the main cause of chemotherapeutic failure and leads to suboptimal response rates . There are no biomarkers of response for close monitoring of TNBC patients to identify chemotherapy failure early. This one-stage phase II study with a single arm is designed to assess the response rate and toxicity of Epirubicin-Cyclophosphamide with Paclitaxel-Carboplatin (ECPC) and examine the potential of using circulating microRNa and circulating tumor cells as a surrogate marker of chemotherapy resistance in Nigerian women with triple negative breast cancer. A total of 42 patients will be enrolled into the trial. Each participant will receive Epirubicin (60mg/m2), Cyclophosphamide (600mg/m2) , Paclitaxel (120mg/m2) and Carboplatin (6AUC) . Blood microRNA and circulating tumor DNA will be determined before and after therapy. Tumor response will be measured by breast ultrasound and described using RECIST criteria while toxicity will be graded using CTCAE criteria. Quality of life (QoL) of participants while on chemotherapy will also be assessed using EORTC quality of life questionnaire - (General and Breast cancer specific).
- Conditions
- Triple Negative Breast Cancer
- Being tested
- Epirubicin, Cyclophosphamide, Paclitaxel, Carboplatin
- Keywords
- Breast cancer, neoadjuvant treatment, microRNA, circulating tumor cells
- Medical subject headings
- Triple Negative Breast Neoplasms, Breast Neoplasms, Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpirubicinDrug
Also called Pharmorubicin, Taxol, Paraplatin, Cytoxan
Epirubicin is an antitumor antibiotics with good activity on breast cancer. It has less cardiotoxic effect than doxorubicin
CyclophosphamideDrug
Also called Cytoxan
Cyclophosphamide is a cytoxic drug indicated for the treatment of many malignancies including breast cancer
PaclitaxelDrug
Also called Taxol
Paclitaxel is a taxane chemotherapy agent indicated for the treatment of many cancers including breast cancer. It can be used alone or in combination with other drugs
CarboplatinDrug
Also called Carboplat, Paraplatin
Carboplatin is a platinum compound indicated for the treatment of many types of malignancies including breast cancer
| Study group | Role | What they receive |
|---|---|---|
| Epirubicin-Cyclophosphamide plus Paclitaxel- Carboplatin | Experimental | Epirubicin 60mg/m2 with cyclophosphamide 600/m2 every three weeks for four courses followed by paclitaxel 120mg/m2 and carboplatin 6 AUC every three weeks for four courses Receives: Drug: Epirubicin; Drug: Cyclophosphamide; Drug: Paclitaxel; Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants achieving pathological complete response (pCR) at surgery following neoadjuvant treatment with epirubicin + cyclophosphamide every three weeks for four cycles followed by paclitaxel + carboplatin every three weeks for four cycles
Percentage of participants achieving pathological complete response (pCR) at surgery
Measured: 4 - 6 months from commencement of chemotherapy. (Surgery will be performed within 4-6 weeks after completion of chemotherapy
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Percentage of participants experiencing grades 3 and 4 hematological, gastro-intestinal, neurological and cardiovascular toxicities.
Measured: From the date of commencement of chemotherapy till date of first documentation of adverse event up to 60 months or withdrawal or death from any cause or which ever occurs first.
Secondary outcomes (2)
Number of Participants without disease for 2 , 5 and 10 years respectively
Invasive Disease Free Survival (iDFS )
Measured: From date of first dose of study drug treatment up to a maximum of 120 months years.
Change in quality of life (QoL) score of patients from baseline using the EORTC quality of life questionnaire during chemotherapy and at study completion
The various domains of QoL over time and the changes from baseline using the validated European Organization for Research and Treatment of Cancer (EORTC)) QoL instrument (global and breast module).
Measured: From date of commencement of study medications up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start29 Nov 2021
- Primary completionMar 2027 (estimated)
- Study completionAug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a one-stage phase II study with a single arm design. All patients will receive 4 cycles of epirubicin + cyclophosphamide followed by paclitaxel +carboplatin for four cycles in the neo-adjuvant setting. Those with clinical response (assessed via breast ultrasound), will undergo surgery. After surgery, all patients who achieve pCR will undergo radiotherapy. Patients with pathological incomplete response or stable disease may have additional chemotherapy at the discretion of the managing physician.
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Hospital, Ibadan
- Sponsor type
- University, hospital or other
- Collaborators
- Lagos State University, Obafemi Awolowo University Teaching Hospital, University of Chicago, University of Lagos, Nigeria, University of Ibadan
- Responsible party
- Principal investigator, Atara Ntekim, University College Hospital, Ibadan
- Investigators
- Olufunmilayo I. Olopade, Study chair, University of ChicagoAtara Ntekim, Principal investigator, University of Ibadan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771871
- Sponsor's protocol ID
- UI-ROD-OCTU02
- Acronym
- TARMAC
- Status last verified
- Apr 2026
- First submitted
- 14 Feb 2021
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification. The data will be deposited with the journal as supplementary data. Access will be as per journals policy
Publications
Adalsteinsson VA, Ha G, Freeman SS, Choudhury AD, Stover DG, Parsons HA, Gydush G, Reed SC, Rotem D, Rhoades J, Loginov D, Livitz D, Rosebrock D, Leshchiner I, Kim J, Stewart C, Rosenberg M, Francis JM, Zhang CZ, Cohen O, Oh C, Ding H, Polak P, Lloyd M, Mahmud S, Helvie K, Merrill MS, Santiago RA, O'Connor EP, Jeong SH, Leeson R, Barry RM, Kramkowski JF, Zhang Z, Polacek L, Lohr JG, Schleicher M, Lipscomb E, Saltzman A, Oliver NM, Marini L, Waks AG, Harshman LC, Tolaney SM, Van Allen EM, Winer EP, Lin NU, Nakabayashi M, Taplin ME, Johannessen CM, Garraway LA, Golub TR, Boehm JS, Wagle N, Getz G, Love JC, Meyerson M. Scalable whole-exome sequencing of cell-free DNA reveals high concordance with metastatic tumors. Nat Commun. 2017 Nov 6;8(1):1324. doi: 10.1038/s41467-017-00965-y.
PubMed 29109393Aebi S, Davidson T, Gruber G, Cardoso F; ESMO Guidelines Working Group. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2011 Sep;22 Suppl 6:vi12-24. doi: 10.1093/annonc/mdr371. No abstract available.
PubMed 21908498Kaufmann M, von Minckwitz G, Mamounas EP, Cameron D, Carey LA, Cristofanilli M, Denkert C, Eiermann W, Gnant M, Harris JR, Karn T, Liedtke C, Mauri D, Rouzier R, Ruckhaeberle E, Semiglazov V, Symmans WF, Tutt A, Pusztai L. Recommendations from an international consensus conference on the current status and future of neoadjuvant systemic therapy in primary breast cancer. Ann Surg Oncol. 2012 May;19(5):1508-16. doi: 10.1245/s10434-011-2108-2. Epub 2011 Dec 23.
PubMed 22193884Mauri D, Pavlidis N, Ioannidis JP. Neoadjuvant versus adjuvant systemic treatment in breast cancer: a meta-analysis. J Natl Cancer Inst. 2005 Feb 2;97(3):188-94. doi: 10.1093/jnci/dji021.
PubMed 15687361
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Response and microRNA Profiles in Triple Negative Breast Cancer Patients Receiving Standard Chemotherapy
- ClinicalTrials.gov ID
- NCT04771871
- Acronym / sponsor ID
- TARMAC / UI-ROD-OCTU02
- Conditions
- Triple Negative Breast Cancer
- Keywords
- Breast cancer, neoadjuvant treatment, microRNA, circulating tumor cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- University College Hospital, IbadanUniversity, hospital or other
- Collaborators
- Lagos State University, Obafemi Awolowo University Teaching Hospital, University of Chicago, University of Lagos, Nigeria, University of Ibadan
- Study start
- 29 Nov 2021 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Aug 2030 (estimated)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Triple negative breast cancer (TNBC) is an aggressive disease with higher proportion of Blacks affected and in younger age groups. There is no targeted therapy unlike other types of breast cancer such as hormone positive and Human Epidermal Growth factor 2 (HER2) positive subtypes. Chemotherapy is therefore the main choice of systemic treatment with rapid development of resistance in most cases. At present, there is no blood test to monitor treatment response and disease relapse. This one-stage phase II study with a single arm design will determine the response rate of standard chemotherapy using Epirubicin (60mg/m2), Cyclophosphamide (600mg/m2) , Paclitaxel (120mg/m2) and Carboplatin (6AUC) in TNBC patients. We will measure the blood level of microRNA molecules and circulating tumor DNA during and after treatment to test if changes can be used to indicate drug failure in these patients. Disease status and tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines while toxicity will be assessed using CTCAE v5). The trial will be conducted as per the International Council on Harmonisation Good Clinical Practice (ICH GCP) Guidelines E6 (R1) and other applicable guidelines
Detailed description
Triple negative subtype of breast cancer (TNBC), accounts for about 55% of all breast cancer among indigenous blacks, such as Nigerians, and younger women are more susceptible Patients with TNBC generally experience a more aggressive clinical course with faster disease progression and poorer overall survival. There is no targeted treatment available beyond conventional cytotoxic chemotherapy . Unfortunately, standard chemotherapy is only effective in about 40% of patients with pathological complete response (pCR) achieved only in 20%-30% . Local relapse occurs early. Therefore, chemo-resistance is the main cause of chemotherapeutic failure and leads to suboptimal response rates . There are no biomarkers of response for close monitoring of TNBC patients to identify chemotherapy failure early. This one-stage phase II study with a single arm is designed to assess the response rate and toxicity of Epirubicin-Cyclophosphamide with Paclitaxel-Carboplatin (ECPC) and examine the potential of using circulating microRNa and circulating tumor cells as a surrogate marker of chemotherapy resistance in Nigerian women with triple negative breast cancer. A total of 42 patients will be enrolled into the trial. Each participant will receive Epirubicin (60mg/m2), Cyclophosphamide (600mg/m2) , Paclitaxel (120mg/m2) and Carboplatin (6AUC) . Blood microRNA and circulating tumor DNA will be determined before and after therapy. Tumor response will be measured by breast ultrasound and described using RECIST criteria while toxicity will be graded using CTCAE criteria. Quality of life (QoL) of participants while on chemotherapy will also be assessed using EORTC quality of life questionnaire - (General and Breast cancer specific).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a one-stage phase II study with a single arm design. All patients will receive 4 cycles of epirubicin + cyclophosphamide followed by paclitaxel +carboplatin for four cycles in the neo-adjuvant setting. Those with clinical response (assessed via breast ultrasound), will undergo surgery. After surgery, all patients who achieve pCR will undergo radiotherapy. Patients with pathological incomplete response or stable disease may have additional chemotherapy at the discretion of the managing physician.
| Arm | Type | Receives |
|---|---|---|
| Epirubicin-Cyclophosphamide plus Paclitaxel- Carboplatin | Experimental | Drug: Epirubicin, Drug: Cyclophosphamide, Drug: Paclitaxel, Drug: CarboplatinEpirubicin 60mg/m2 with cyclophosphamide 600/m2 every three weeks for four courses followed by paclitaxel 120mg/m2 and carboplatin 6 AUC every three weeks for four courses |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Women ages of 18 to 70 years old
- Women who give informed consent for the study
- Biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm)
- Patients with histologically confirmed carcinoma of the female breast with triple negative status by immuno-histochemistry (IHC)
- Clinical stages IIA -IIIC (AJCC 2009)
Key exclusion criteria (6 listed)
- 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.
- Patients with distant metastasis (brain and/or visceral metastasis)
- Serious, uncontrolled, concurrent infection(s).
- Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)
- Participation in any investigational drug study within 4 weeks preceding the start of study treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpirubicinAlso: Pharmorubicin, Taxol, Paraplatin, CytoxanEpirubicin is an antitumor antibiotics with good activity on breast cancer. It has less cardiotoxic effect than doxorubicin | Drug | Epirubicin-Cyclophosphamide plus Paclitaxel- Carboplatin |
| CyclophosphamideAlso: CytoxanCyclophosphamide is a cytoxic drug indicated for the treatment of many malignancies including breast cancer | Drug | Epirubicin-Cyclophosphamide plus Paclitaxel- Carboplatin |
| PaclitaxelAlso: TaxolPaclitaxel is a taxane chemotherapy agent indicated for the treatment of many cancers including breast cancer. It can be used alone or in combination with other drugs | Drug | Epirubicin-Cyclophosphamide plus Paclitaxel- Carboplatin |
| CarboplatinAlso: Carboplat, ParaplatinCarboplatin is a platinum compound indicated for the treatment of many types of malignancies including breast cancer | Drug | Epirubicin-Cyclophosphamide plus Paclitaxel- Carboplatin |
Primary outcome
Number of participants achieving pathological complete response (pCR) at surgery following neoadjuvant treatment with epirubicin + cyclophosphamide every three weeks for four cycles followed by paclitaxel + carboplatin every three weeks for four cycles
Time frame: 4 - 6 months from commencement of chemotherapy. (Surgery will be performed within 4-6 weeks after completion of chemotherapy
Percentage of participants achieving pathological complete response (pCR) at surgery
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Time frame: From the date of commencement of chemotherapy till date of first documentation of adverse event up to 60 months or withdrawal or death from any cause or which ever occurs first.
Percentage of participants experiencing grades 3 and 4 hematological, gastro-intestinal, neurological and cardiovascular toxicities.
2 secondary outcomes
Number of Participants without disease for 2 , 5 and 10 years respectively
Time frame: From date of first dose of study drug treatment up to a maximum of 120 months years.
Change in quality of life (QoL) score of patients from baseline using the EORTC quality of life questionnaire during chemotherapy and at study completion
Time frame: From date of commencement of study medications up to 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Background: PubMed 29109393Adalsteinsson VA, Ha G, Freeman SS, Choudhury AD, Stover DG, Parsons HA, Gydush G, Reed SC, Rotem D, Rhoades J, Loginov D, Livitz D, Rosebrock D, Leshchiner I, Kim J, Stewart C, Rosenberg M, Francis JM, Zhang CZ, Cohen O, Oh C, Ding H, Polak P, Lloyd M, Mahmud S, Helvie K, Merrill MS, Santiago RA, O'Connor EP, Jeong SH, Leeson R, Barry RM, Kramkowski JF, Zhang Z, Polacek L, Lohr JG, Schleicher M, Lipscomb E, Saltzman A, Oliver NM, Marini L, Waks AG, Harshman LC, Tolaney SM, Van Allen EM, Winer EP, Lin NU, Nakabayashi M, Taplin ME, Johannessen CM, Garraway LA, Golub TR, Boehm JS, Wagle N, Getz G, Love JC, Meyerson M. Scalable whole-exome sequencing of cell-free DNA reveals high concordance with metastatic tumors. Nat Commun. 2017 Nov 6;8(1):1324. doi: 10.1038/s41467-017-00965-y.
- Background: PubMed 21908498Aebi S, Davidson T, Gruber G, Cardoso F; ESMO Guidelines Working Group. Primary breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2011 Sep;22 Suppl 6:vi12-24. doi: 10.1093/annonc/mdr371. No abstract available.
- Background: PubMed 22193884Kaufmann M, von Minckwitz G, Mamounas EP, Cameron D, Carey LA, Cristofanilli M, Denkert C, Eiermann W, Gnant M, Harris JR, Karn T, Liedtke C, Mauri D, Rouzier R, Ruckhaeberle E, Semiglazov V, Symmans WF, Tutt A, Pusztai L. Recommendations from an international consensus conference on the current status and future of neoadjuvant systemic therapy in primary breast cancer. Ann Surg Oncol. 2012 May;19(5):1508-16. doi: 10.1245/s10434-011-2108-2. Epub 2011 Dec 23.
- Background: PubMed 15687361Mauri D, Pavlidis N, Ioannidis JP. Neoadjuvant versus adjuvant systemic treatment in breast cancer: a meta-analysis. J Natl Cancer Inst. 2005 Feb 2;97(3):188-94. doi: 10.1093/jnci/dji021.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification. The data will be deposited with the journal as supplementary data. Access will be as per journals policy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olufunmilayo I. Olopade study chair
University of Chicago
Atara Ntekim principal investigator
University of Ibadan
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Epirubicin, Cyclophosphamide and Paclitaxel in people with Triple Negative Breast Cancer, run by University College Hospital, Ibadan at 4 sites in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tonyin Aniagwu (234-8033535370, taniagwu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants achieving pathological complete response (pCR) at surgery following neoadjuvant treatment with epirubicin + cyclophosphamide every three weeks for four cycles followed by paclitaxel + carboplatin every three weeks for four cycles (time frame: 4 - 6 months from commencement of chemotherapy. (Surgery will be performed within 4-6 weeks after completion of chemotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04771871, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.