Human Epidermal Growth Factor 2 Negative Carcinoma of BreastPhase 2NCT06348134
Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery
A Phase 2 study testing Trastuzumab emtansine, Pertuzumab Injection and Docetaxel in people with Human Epidermal Growth Factor 2 Negative Carcinoma of Breast and HER2-positive Breast Cancer, run by University of Chicago at 4 sites in Nigeria.
Trial summary
Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, HER2-positive Breast Cancer, Breast Cancer
- What is being tested?
- Trastuzumab emtansine, Pertuzumab Injection and Docetaxel
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 4 sitesNigeria
- Study dates
- 18 Mar 2025to 1 Jul 2036
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent must be obtained prior to any screening procedures
- Women ages of 18 to 70 years old
- Biopsy-accessible breast tumor of significant size for core needle biopsy /ultrasound measurable (≥ 2cm)
- Measurable breast tumour using ultrasonography (≥ 2cm)
- Patients with histologically confirmed carcinoma of the female breast with positive HER2 status
- Clinical stages 2A -3C. (AJCC 2009)
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- Chemotherapy-naïve patients (for this malignancy)
- Performance status: Eastern Cooperative Oncology Group performance status 0-3
- Non-pregnant and not nursing. Women of childbearing potential must take the pregnancy test and must commit to receive hormone therapy with 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/mL 2. Platelet count ≥ 100,000/mL 3. Absolute neutrophil count ≥ l500/mL 4. Hemoglobin 10g/dL 5. Bilirubin ≤ 1.5 x upper limit of normal 6. serum glutamic-oxaloacetic transaminase (SGOT) and Serum glutamic pyruvic transaminase (SGPT) < 2.5 x upper limit of normal for patients without liver metastases 7. Creatinine within institutional normal limits or glomerular filtration rate ≥ 30 mL/min/1.73 m2 by Chronic Kidney Disease Epidemiology Collaboration equation (see http://mdrd.com/ for calculator) 8. Echocardiogram: Baseline left ventricular ejection fraction of ≥ 55%
Who cannot join
- Patients eligible for this study must not meet any of the following criteria:
- Pregnant or lactating women. Women of childbearing potential not using a reliable and appropriate contraceptive method. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Patients will agree to continue the use of acceptable form of contraception for 7 months from the date of last drug administration (Herceptin).
- Patients with distant metastasis
- Serious, uncontrolled, concurrent infection(s).
- Patients who have received more than 4 weeks of tamoxifen therapy for this malignancy. Patient who have received tamoxifen or raloxifene for purposes of chemoprevention (e.g. Breast Cancer Prevention Trial or for other past indications (including previous breast cancer) are eligible. Tamoxifen or raloxifene therapy will be discontinued at least one month before the patient is enrolled on this study.
- Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)
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- 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.
- Unwillingness to participate or inability to comply with the protocol for the duration of the study
- Patients with human epidermal growth factor receptor 2 (HER2-negative) disease
- History of documented heart failure or systolic dysfunction (LVEF < 50%), High-risk uncontrolled arrhythmias ie, atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade Atrioventricular (AV)-block (second degree AV-block Type 2 [Mobitz 2] or third degree AV-block),
- Angina pectoris requiring anti-anginal medication,
- Clinically significant valvular heart disease
- Poorly controlled hypertension (eg, systolic > 180 mm Hg or diastolic > 100 mm Hg)
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 of Ibadan Hospital
Ibadan, Oyo State, 200285
ATARA NTEKIM, +234-805 207 6619
AYORINDE FOLASIRE, +234-802-887-9622
- Recruiting
Lagos State University Teaching Hospital
Ikeja, Lagos, 100271
ABIODUN POPOOLA, +234 803 3021434
ADEMOLA OYEKAN, +234 803 9277218
- Recruiting
Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC)
Ile-Ife, Osun State, 220005
Olalekan Olasehinde, 2348060716670, lekanolasehinde@yahoo.com
Ifeoluwa Olagunju, 2347053670305, ifeoluwaolagunju4@gmail.com
- Recruiting
Lagos University Teaching Hospital
Yaba, Lagos, 100254
ANTHONIA SOWUNMI, +234 803 7216723
ADEWUNMI ALABI, +234 805 284 3206
About this study
Official title: Assessing the Efficacy and Safety of Optimal Neoadjuvant to Adjuvant Anti-HER2- Based Therapy in Nigerian Women With HER2+ Breast Cancer
Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery.
Read the detailed description
Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery. Participants with HER2-positive breast cancer will receive a combination of trastuzumab with pertuzumab (PHESGO) plus chemotherapy.
- Conditions
- Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, HER2-positive Breast Cancer, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab emtansineDrug
Also called Kadcyla, T-DMI
A chemotherapy drug.
Pertuzumab InjectionDrug
Also called Perjeta
A prescription medicine that is approved for use in combination with trastuzumab and docetaxel in people who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer.
DocetaxelDrug
Also called Taxotere, Docefrez
A chemotherapy drug.
TamoxifenDrug
Also called Soltamox
A medication used to treat breast cancer.
LetrozoleDrug
A medication used to treat breast cancer.
GoserelinDrug
Also called Zoladex
A hormone therapy drug.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: All Participants | Experimental | All participants will receive a combination of:
* docetaxel (starting dose - 75 mg/m2), increasing to 100mg/m2 by cycle 2 (if tolerated) for 4-6 cycles (for a total of 18 weeks). Docetaxel will be give as an injection.
* trastuzumab and pertuzumab (loading dose of 1200 mg of pertuzumab and 600 mg trastuzumab) for 52 weeks followed by 600 mg pertuzumab and 600 mg trastuzumab every 3 weeks for 15 cycles (for a total of 52 weeks). These two drugs will be given as subcutaneous injections under the skin. Receives: Drug: Trastuzumab emtansine; Drug: Pertuzumab Injection; Drug: Docetaxel |
| Phase 2 - Operable (participants who are able to have surgery) | Experimental | Participants in this group will have breast cancer that shows a complete or incomplete response (as assessed by ultrasound) to the study drug combination given in phase 1 of study. Based on how their breast cancer responds to the phase 1 study drugs, participants in this group will:
- undergo surgery and will continue to receive pertuzumab (600 mg) and trastuzumab (600 mg) for 36 weeks. Participants may also receive hormone therapy (as recommended by study doctor) based on status of breast cancer. This drug will be given as an injection under the skin.
Some participants in this group may also receive tamoxifen (as an oral tablet; 20 mg daily for 10 years after surgery), letrozole (as an oral tablet 2.5 mg daily for 10 years after surgery) and/or goserelin (hormone injection 10.8 mg every 1-3 months) based on their human epidermal growth factor receptor 2 (HER2) status as assessed by the treating doctor. Receives: Drug: Trastuzumab emtansine; Drug: Pertuzumab Injection; Drug: Docetaxel; Drug: Tamoxifen; Drug: Letrozole; Drug: Goserelin |
| Phase 2 - Inoperable (participants who are not able to have surgery) | Experimental | Participants in this group will have breast cancer that shows a partial response (as assessed by ultrasound) to the study drugs given in phase 1 or their breast cancer stayed the same or got worse after receiving study drugs during phase 1. Based on how their breast cancer responds to the phase 1 study drug regimen, participants in this group will receive trastuzumab emtansine (intravenously) plus standard chemotherapy as recommended by their doctor. Receives: Drug: Trastuzumab emtansine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Complete Response
Pathological complete response of giving three-weekly docetaxel + subcutaneous trastuzumab and Pertuzumab with Tamoxifen/Letrozole added ) to Nigerian women with Human epidermal growth factor receptor 2 (HER2-positive) breast cancer as assessed by the absence of invasive neoplastic cells at microscopic examination of the primary tumor and lymph nodes at surgery.
Measured: 10 years
Secondary outcomes (5)
Reported Adverse Events and clinical/medical records of participants
Reported adverse events among participants receiving three-weekly docetaxel + subcutaneous trastuzumab and Pertuzumab with Tamoxifen/Letrozole added ) to Nigerian women with Human epidermal growth factor receptor 2 (HER2-positive) breast cancer as assessed by the incidence and severity of adverse events and serious adverse drug reactions including clinical laboratory values, vital signs, electrocardiogram and dose interruptions. Adverse events will be defined by the Common Terminology Criteria for Adverse Events (CTCAE Grade 4)
Measured: 10 years
Percentage of participants who are suitable for breast-conserving surgery
To determine suitability of patients for breast conserving surgery after neoadjuvant treatment with docetaxel and PHESGO as assessed by the percentage of patients with breast conservative surgery following neoadjuvant therapy.
Measured: 10 years
Event-free survival duration reported among participants
Event-free responses defined as time from first dose of study drug treatment to progression or death due to any cause, as assessed by investigators.
Measured: 10 years
Quality of life reported among study participants
Quality of life (QoL) will be assessed by various domains of QoL over time and the changes from baseline using a QoL instrument (a global/breast module) validated by the European Organization for Research and Treatment of Cancer (EORTC). QLQ-C30 version 3.0 and Breast Cancer Module QLQ-BR23 low scores on scale of 0-4 indicates better financial wellbeing
Measured: 10 years
Genetic and epigenetic factors associated with breast cancer in Nigeria
To assess the genetic and epigenetic factors associated with breast cancer in Nigeria asa assessed by correlative study of molecular markers and tumor subtypes/tumor biology with patient's characteristics, response or resistance to treatment and participants' outcome.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start18 Mar 2025
- Primary completion1 Jul 2034 (estimated)
- Study completion1 Jul 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Epidermal Growth Factor 2 Negative Carcinoma of BreastStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olufunmilayo Olopade, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348134
- Sponsor's protocol ID
- IRB23-0502
- Status last verified
- Feb 2026
- First submitted
- 29 Mar 2024
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy and Safety of Optimal Neoadjuvant to Adjuvant Anti-HER2- Based Therapy in Nigerian Women With HER2+ Breast Cancer
- ClinicalTrials.gov ID
- NCT06348134
- Acronym / sponsor ID
- IRB23-0502
- Conditions
- Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, HER2-positive Breast Cancer, Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 1 Jul 2034 (estimated)
- Study completion
- 1 Jul 2036 (estimated)
- First posted
- 4 Apr 2024 (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.
Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery.
Detailed description
Doctors leading this study would like to learn about providing cancer treatment/therapies to Nigerian women with breast cancer based on their human epidermal growth factor receptor 2 (HER2) status. This study will focus on the efficacy and safety of anti-HER2 cancer treatment before and after surgery. Participants with HER2-positive breast cancer will receive a combination of trastuzumab with pertuzumab (PHESGO) plus chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1: All Participants | Experimental | Drug: Trastuzumab emtansine, Drug: Pertuzumab Injection, Drug: DocetaxelAll participants will receive a combination of: * docetaxel (starting dose - 75 mg/m2), increasing to 100mg/m2 by cycle 2 (if tolerated) for 4-6 cycles (for a total of 18 weeks). Docetaxel will be give as an injection. * trastuzumab and pertuzumab (loading dose of 1200 mg of pertuzumab and 600 mg trastuzumab) for 52 weeks followed by 600 mg pertuzumab and 600 mg trastuzumab every 3 weeks for 15 cycles (for a total of 52 weeks). These two drugs will be given as subcutaneous injections under the skin. |
| Phase 2 - Operable (participants who are able to have surgery) | Experimental | Drug: Trastuzumab emtansine, Drug: Pertuzumab Injection, Drug: Docetaxel, Drug: Tamoxifen, Drug: Letrozole, Drug: GoserelinParticipants in this group will have breast cancer that shows a complete or incomplete response (as assessed by ultrasound) to the study drug combination given in phase 1 of study. Based on how their breast cancer responds to the phase 1 study drugs, participants in this group will: - undergo surgery and will continue to receive pertuzumab (600 mg) and trastuzumab (600 mg) for 36 weeks. Participants may also receive hormone therapy (as recommended by study doctor) based on status of breast cancer. This drug will be given as an injection under the skin. Some participants in this group may also receive tamoxifen (as an oral tablet; 20 mg daily for 10 years after surgery), letrozole (as an oral tablet 2.5 mg daily for 10 years after surgery) and/or goserelin (hormone injection 10.8 mg every 1-3 months) based on their human epidermal growth factor receptor 2 (HER2) status as assessed by the treating doctor. |
| Phase 2 - Inoperable (participants who are not able to have surgery) | Experimental | Drug: Trastuzumab emtansineParticipants in this group will have breast cancer that shows a partial response (as assessed by ultrasound) to the study drugs given in phase 1 or their breast cancer stayed the same or got worse after receiving study drugs during phase 1. Based on how their breast cancer responds to the phase 1 study drug regimen, participants in this group will receive trastuzumab emtansine (intravenously) plus standard chemotherapy as recommended by their doctor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Written informed consent must be obtained prior to any screening procedures
- Women ages of 18 to 70 years old
- Biopsy-accessible breast tumor of significant size for core needle biopsy /ultrasound measurable (≥ 2cm)
- Measurable breast tumour using ultrasonography (≥ 2cm)
- Patients with histologically confirmed carcinoma of the female breast with positive HER2 status
Key exclusion criteria (14 listed)
- Pregnant or lactating women. Women of childbearing potential not using a reliable and appropriate contraceptive method. Postmenopausal women must have been amenorrhoeic for at least 12 months to be considered of non-childbearing potential. Patients will agree to continue the use of acceptable form of contraception for 7 months from the date of last drug administration (Herceptin).
- Patients with distant metastasis
- Serious, uncontrolled, concurrent infection(s).
- Patients who have received more than 4 weeks of tamoxifen therapy for this malignancy. Patient who have received tamoxifen or raloxifene for purposes of chemoprevention (e.g. Breast Cancer Prevention Trial or for other past indications (including previous breast cancer) are eligible. Tamoxifen or raloxifene therapy will be discontinued at least one month before the patient is enrolled on this study.
- Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)
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 |
|---|---|---|
| Trastuzumab emtansineAlso: Kadcyla, T-DMIA chemotherapy drug. | Drug | Phase 1: All Participants, Phase 2 - Inoperable (participants who are not able to have surgery), Phase 2 - Operable (participants who are able to have surgery) |
| Pertuzumab InjectionAlso: PerjetaA prescription medicine that is approved for use in combination with trastuzumab and docetaxel in people who have HER2-positive breast cancer that has spread to different parts of the body (metastatic) and who have not received anti-HER2 therapy or chemotherapy for metastatic breast cancer. | Drug | Phase 1: All Participants, Phase 2 - Operable (participants who are able to have surgery) |
| DocetaxelAlso: Taxotere, DocefrezA chemotherapy drug. | Drug | Phase 1: All Participants, Phase 2 - Operable (participants who are able to have surgery) |
| TamoxifenAlso: SoltamoxA medication used to treat breast cancer. | Drug | Phase 2 - Operable (participants who are able to have surgery) |
| LetrozoleA medication used to treat breast cancer. | Drug | Phase 2 - Operable (participants who are able to have surgery) |
| GoserelinAlso: ZoladexA hormone therapy drug. | Drug | Phase 2 - Operable (participants who are able to have surgery) |
Primary outcome
Pathological Complete Response
Time frame: 10 years
Pathological complete response of giving three-weekly docetaxel + subcutaneous trastuzumab and Pertuzumab with Tamoxifen/Letrozole added ) to Nigerian women with Human epidermal growth factor receptor 2 (HER2-positive) breast cancer as assessed by the absence of invasive neoplastic cells at microscopic examination of the primary tumor and lymph nodes at surgery.
5 secondary outcomes
Reported Adverse Events and clinical/medical records of participants
Time frame: 10 years
Percentage of participants who are suitable for breast-conserving surgery
Time frame: 10 years
Event-free survival duration reported among participants
Time frame: 10 years
Quality of life reported among study participants
Time frame: 10 years
Genetic and epigenetic factors associated with breast cancer in Nigeria
Time frame: 10 years
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 17 Feb 2026.
- Individual participant dataSharing planned: Yes
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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 Olopade principal investigator
University of Chicago
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 Trastuzumab emtansine, Pertuzumab Injection and Docetaxel in people with Human Epidermal Growth Factor 2 Negative Carcinoma of Breast and HER2-positive Breast Cancer, run by University of Chicago 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 11 inclusion and 14 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 17 Feb 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 Olufunmilayo Olopade ((773) 702-1632, folopade@medicine.bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Complete Response (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.