Breast CancerPhase 2NCT03879577
Assessing the Response Rate of Neo-adjuvant Taxotere and Trastuzumab in Nigerian Women With Breast Cancer
A Phase 2 study testing Docetaxel, Herceptin and FEC in people with Breast Cancer and Breast Cancer Female, run by University of Chicago at 1 site in Nigeria.
Trial summary
This is a one stage phase II study with a single arm design. It will be conducted in HER-2 positive breast cancer patients in Nigeria who are chemotherapy/hormonal treatment naive. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Female, HER2-positive Breast Cancer
- What is being tested?
- Docetaxel, Herceptin and FEC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteNigeria
- Study dates
- 25 Nov 2019to 30 Sep 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm)
- Patients with histologically confirmed carcinoma of the female breast with 3+ positive HER2 status by IHC
- Clinical stages IIA -IIIC (AJCC 2009)
- Chemotherapy-naïve patients (for this malignancy)
- Performance status: ECOG performance status 0-1 (Appendix A)
Show all 10Show fewer
- Non-pregnant and not nursing. Women of childbearing potential must take the pregnancy test and must commit to receive 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 CKD EPI equation (see http://mdrd.com/ for calculator)
- 9. 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 of childbearing potential will agree to continue the use of acceptable form of contraception for 24 months from the date of last Herceptin administration.
- 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.
- Patients with HER2-negative disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing REsponse to Neoadjuvant Taxotere and Trastuzumab in Nigerian Women With HER2-positive Breast Cancer (ARETTA)
This is a one stage phase II study with a single arm design. It will be conducted in HER-2 positive breast cancer patients in Nigeria who are chemotherapy/hormonal treatment naive.
- Conditions
- Breast Cancer, Breast Cancer Female, HER2-positive Breast Cancer, Breast Cancer Stage II, Breast Cancer Stage III
- Keywords
- breast cancer, breast cancer stage II, Breast Cancer Stage III, Docetaxel, Herceptin, neoadjuvant treatment, nigeria
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DocetaxelDrug
Administered to all patients for a minimum of 4 cycles for 12 weeks.
HerceptinDrug
Also called Trastuzumab
Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel.
FECDrug
Only administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable).
TamoxifenDrug
Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.
LetrozoleDrug
Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.
LHRH agonistDrug
Administered to all premenopausal patients.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant taxotere and trastuzumab | Experimental | Investigators will give patients docetaxel/taxotere through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done.
Herceptin/trastuzumab will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive
Patients with a poor response to docetaxal/herceptin will receive Fluorouracil, Epirubicin Hydrochloride, Cyclophonsphamide (FEC) injection by drip every 3 weeks.
Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study. Receives: Drug: Docetaxel; Drug: Herceptin; Drug: FEC; Drug: Tamoxifen; Drug: Letrozole; Drug: LHRH agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Complete Pathologic Response (pCR)
Pathological complete response in the breast is defined as the absence of invasive cells at microscopic examination of the primary tumor and lymph nodes at surgery. Any remaining in-situ lesions are permissible. Participants with invalid/missing pCR assessments will be defined as non-responders.
Measured: 4-6 months
Secondary outcomes (12)
Number of Participants With Adverse Events
Incidence and severity of adverse drug reactions (AE) and serious adverse drug reactions (SAE) including clinical laboratory values, vital signs, ECGs and dose interruptions.
Measured: 4-6 months
Progression-free Survival (PFS)
Time from enrollment to disease recurrence or death from any cause.
Measured: From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 10 years
Duration of Response (DOR)
Time from pathological complete response to disease recurrence or death
Measured: Up to 10 years
Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Health From Baseline to End of Neoadjuvant Therapy.
Global health status from EORTC QLQ-C30 instrument. Overall health rating on a scale from 1 (very poor) to 7 (excellent). Higher scores indicate better outcome. Values represent changes from baseline with positive values indicating improvement and negative values indicating worsening.
Measured: From start date of therapy to end of neoadjuvant therapy approximately 4 - 6 months from commencement of chemotherapy
Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Quality of Life From Baseline to End of Neoadjuvant Therapy.
Global quality of life status from EORTC QLQ-C30 instrument. Overall quality of life rating on a scale from 1 (very poor) to 7 (excellent). Higher scores indicate better outcome. Values represent changes from baseline with positive values indicating improvement and negative values indicating worsening.
Measured: From start date of therapy to end of neoadjuvant therapy approximately 4 - 6 months from commencement of chemotherapy
Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Health From Baseline to 6 Months Post-therapy.
Global health status from EORTC QLQ-C30 instrument. Overall health rating on a scale from 1 (very poor) to 7 (excellent). Higher scores indicate better outcome. Values represent changes from baseline with positive values indicating improvement and negative values indicating worsening.
Measured: From start date of therapy to 6 months post-therapy
Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Quality of Life From Baseline to 6 Months Post-therapy.
Global quality of life status from EORTC QLQ-C30 instrument. Overall quality of life rating on a scale from 1 (very poor) to 7 (excellent). Higher scores indicate better outcome. Values represent changes from baseline with positive values indicating improvement and negative values indicating worsening.
Measured: From start date of therapy to 6 months post-therapy
Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC
The various domains of QoL over time and the changes from baseline using the validated (by the European Organization for Research and Treatment of Cancer (EORTC)) QoL instrument (global and breast module).
Measured: From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 10 years
Blood Concentrations of Herceptin SC Given in Combination With Docetaxel
Blood concentrations of Herceptin SC at multiple time points using the peak exposure
Measured: 21 days
Drug Plasma Concentration of Herceptin SC Given in Combination With FEC
Determine the pharmacokinetic profile of Herceptin SC given in combination with FEC following poor response to TH
Measured: 21 days
The Cardiac Toxicity Associated With TscH With FEC +scH in Breast Cancer Patients
The percentage of participants with Heart failure (NYHA Class III or IV or as confirmed by a cardiologist) or a decrease in LVEF of at least 10 EF points from baseline and to below 50%.
Measured: Through study completion an average of two years
The Cardiac Toxicity Associated With TscH Without FEC +scH in Breast Cancer Patients
The percentage of participants with Heart failure (NYHA Class III or IV or as confirmed by a cardiologist) and a decrease in LVEF of at least 10 EF points from baseline and to below 50%.
Measured: Through study completion an average of two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start25 Nov 2019
- Primary completion30 Mar 2023
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olufunmilayo I Olopade, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03879577
- Sponsor's protocol ID
- IRB18-1178
- Status last verified
- Aug 2025
- First submitted
- 12 Feb 2019
- Last updated
- 21 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Ntekim AI, Ibraheem A, Sofoluwe AA, Kotila O, Babalola C, Karrison T, Olopade CO. ARETTA: Assessing Response to Neoadjuvant Taxotere and Subcutaneous Trastuzumab in Nigerian Women With HER2-Positive Breast Cancer: A Study Protocol. JCO Glob Oncol. 2020 Jul;6:983-990. doi: 10.1200/GO.20.00043.
PubMed 32628583
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing REsponse to Neoadjuvant Taxotere and Trastuzumab in Nigerian Women With HER2-positive Breast Cancer (ARETTA)
- ClinicalTrials.gov ID
- NCT03879577
- Acronym / sponsor ID
- IRB18-1178
- Conditions
- Breast Cancer, Breast Cancer Female, HER2-positive Breast Cancer, Breast Cancer Stage II, Breast Cancer Stage III
- Keywords
- breast cancer, breast cancer stage II, Breast Cancer Stage III, Docetaxel, Herceptin, neoadjuvant treatment, nigeria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 25 Nov 2019 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 19 Mar 2019 (actual)
- Results
- Posted 21 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a one stage phase II study with a single arm design. It will be conducted in HER-2 positive breast cancer patients in Nigeria who are chemotherapy/hormonal treatment naive.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant taxotere and trastuzumab | Experimental | Drug: Docetaxel, Drug: Herceptin, Drug: FEC, Drug: Tamoxifen, Drug: Letrozole, Drug: LHRH agonistInvestigators will give patients docetaxel/taxotere through drip every 3 weeks for four doses for 12 weeks before a repeat breast ultrasound. After breast ultrasound, if the investigator feels the injection is good, surgery will be done. Herceptin/trastuzumab will be given to patients under the skin of the thigh every 3 weeks for 18 times if they are HER2-positive Patients with a poor response to docetaxal/herceptin will receive Fluorouracil, Epirubicin Hydrochloride, Cyclophonsphamide (FEC) injection by drip every 3 weeks. Hormone-receptor positive patients will receive hormonal therapy with tamoxifen or letrozole after surgery, radiotherapy and LHRH agonist according to the expression of hormone receptors and according to the state of primary menopause at the onset of the study. |
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
- Biopsy-accessible breast tumor of significant size for core needle biopsy/ultrasound measurable (≥ 2cm)
- Patients with histologically confirmed carcinoma of the female breast with 3+ positive HER2 status by IHC
- Clinical stages IIA -IIIC (AJCC 2009)
- Chemotherapy-naïve patients (for this malignancy)
Key exclusion criteria (7 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 of childbearing potential will agree to continue the use of acceptable form of contraception for 24 months from the date of last Herceptin administration.
- 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 |
|---|---|---|
| DocetaxelAdministered to all patients for a minimum of 4 cycles for 12 weeks. | Drug | Neoadjuvant taxotere and trastuzumab |
| HerceptinAlso: TrastuzumabAdministered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel. | Drug | Neoadjuvant taxotere and trastuzumab |
| FECOnly administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable). | Drug | Neoadjuvant taxotere and trastuzumab |
| TamoxifenOnly administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. | Drug | Neoadjuvant taxotere and trastuzumab |
| LetrozoleOnly administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole. | Drug | Neoadjuvant taxotere and trastuzumab |
| LHRH agonistAdministered to all premenopausal patients. | Drug | Neoadjuvant taxotere and trastuzumab |
Primary outcome
Number of Participants With Complete Pathologic Response (pCR)
Time frame: 4-6 months
Pathological complete response in the breast is defined as the absence of invasive cells at microscopic examination of the primary tumor and lymph nodes at surgery. Any remaining in-situ lesions are permissible. Participants with invalid/missing pCR assessments will be defined as non-responders.
12 secondary outcomes
Number of Participants With Adverse Events
Time frame: 4-6 months
Progression-free Survival (PFS)
Time frame: From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 10 years
Duration of Response (DOR)
Time frame: Up to 10 years
Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Health From Baseline to End of Neoadjuvant Therapy.
Time frame: From start date of therapy to end of neoadjuvant therapy approximately 4 - 6 months from commencement of chemotherapy
Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Quality of Life From Baseline to End of Neoadjuvant Therapy.
Time frame: From start date of therapy to end of neoadjuvant therapy approximately 4 - 6 months from commencement of chemotherapy
Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Health From Baseline to 6 Months Post-therapy.
Time frame: From start date of therapy to 6 months post-therapy
Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC. Overall Quality of Life From Baseline to 6 Months Post-therapy.
Time frame: From start date of therapy to 6 months post-therapy
Analysis of Changes From Baseline Using the Quality of Life (QoL) Instrument: EORTC
Time frame: From start date of therapy to the date of first documented disease progression or death from any cause, whichever may come first, assessed up to 10 years
Blood Concentrations of Herceptin SC Given in Combination With Docetaxel
Time frame: 21 days
Drug Plasma Concentration of Herceptin SC Given in Combination With FEC
Time frame: 21 days
The Cardiac Toxicity Associated With TscH With FEC +scH in Breast Cancer Patients
Time frame: Through study completion an average of two years
The Cardiac Toxicity Associated With TscH Without FEC +scH in Breast Cancer Patients
Time frame: Through study completion an average of two years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32628583Ntekim AI, Ibraheem A, Sofoluwe AA, Kotila O, Babalola C, Karrison T, Olopade CO. ARETTA: Assessing Response to Neoadjuvant Taxotere and Subcutaneous Trastuzumab in Nigerian Women With HER2-Positive Breast Cancer: A Study Protocol. JCO Glob Oncol. 2020 Jul;6:983-990. doi: 10.1200/GO.20.00043.
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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. This study is not recruiting at the moment.
Olufunmilayo I Olopade, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Docetaxel, Herceptin and FEC in people with Breast Cancer and Breast Cancer Female, run by University of Chicago at 1 site 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 7 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: under way, not looking for participants, as of the sponsor's last update on 21 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 21 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Complete Pathologic Response (pCR) (time frame: 4-6 months). 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 NCT03879577, which also lists 1 linked publication.
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 21 Jan 2026.