Testing anti-HER2 treatment before and after surgery for Nigerian women with HER2+ breast cancer

Assessing the Efficacy and Safety of Optimal Neoadjuvant to Adjuvant Anti-HER2- Based Therapy in Nigerian Women With HER2+ Breast Cancer

This study will test whether giving anti-HER2 drugs with chemotherapy before and after surgery helps Nigerian women with HER2-positive breast cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of Chicago (Academic / other)
• Drugs / interventions: Chemotherapy, trastuzumab, pertuzumab
• Locations: 4 sites (Ikeja, Lagos and 3 other locations)
• Trial ID: NCT06348134 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study enrolls Nigerian women with biopsy-confirmed HER2‑positive breast cancer (clinical stages IIA–IIIC) and measurable tumors of at least 2 cm. Participants receive dual anti‑HER2 therapy (trastuzumab plus pertuzumab, delivered as PHESGO or injections) combined with chemotherapy such as docetaxel, with additional agents like trastuzumab emtansine or endocrine therapy used as appropriate after surgery. Treatments are given before surgery (neoadjuvant) to shrink tumors and again after surgery (adjuvant) to reduce recurrence risk, with safety and tumor response monitored throughout. The trial is conducted at three tertiary hospitals in Nigeria and follows standard lab and performance‑status eligibility criteria.

Who should consider this trial

Good fit: Women 18–70 years old with biopsy‑confirmed HER2‑positive breast cancer, measurable tumor ≥2 cm, clinical stage IIA–IIIC, chemotherapy‑naïve for this cancer, ECOG performance status 0–3, non‑pregnant and willing to follow protocol contraception and goserelin when required are ideal candidates.

Not a fit: Patients who are HER2‑negative, pregnant or nursing, have received prior chemotherapy for this cancer, have tumors smaller than 2 cm, or have significant organ dysfunction are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, the regimen could shrink tumors before surgery and reduce the risk of cancer coming back.

How similar studies have performed: Previous international trials have shown that combining trastuzumab and pertuzumab with chemotherapy improves tumor response and outcomes, so the approach is evidence‑based though it is less well studied specifically in Nigerian populations.

Eligibility criteria

Inclusion Criteria:

Written informed consent must be obtained prior to any screening procedures

1. Women ages of 18 to 70 years old
2. Biopsy-accessible breast tumor of significant size for core needle biopsy /ultrasound measurable (≥ 2cm)
3. Measurable breast tumour using ultrasonography (≥ 2cm)
4. Patients with histologically confirmed carcinoma of the female breast with positive HER2 status
5. Clinical stages 2A -3C. (AJCC 2009)
6. Chemotherapy-naïve patients (for this malignancy)
7. Performance status: Eastern Cooperative Oncology Group performance status 0-3
8. 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
9. 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%

Exclusion Criteria:

Patients eligible for this study must not meet any of the following criteria:

1. 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).
2. Patients with distant metastasis
3. Serious, uncontrolled, concurrent infection(s).
4. 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.
5. Treatment for other carcinomas within the last 5 years, except non-melanoma skin cancer and treated cervical carcinoma in-situ (CCIS)
6. Participation in any investigational drug study within 4 weeks preceding the start of study treatment
7. 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.
8. Unwillingness to participate or inability to comply with the protocol for the duration of the study
9. Patients with human epidermal growth factor receptor 2 (HER2-negative) disease
10. 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),
11. Angina pectoris requiring anti-anginal medication,
12. Clinically significant valvular heart disease
13. Poorly controlled hypertension (eg, systolic \> 180 mm Hg or diastolic \> 100 mm Hg)

Where this trial is running

Ikeja, Lagos and 3 other locations

• Lagos State University Teaching Hospital — Ikeja, Lagos, Nigeria (Recruiting)
• Lagos University Teaching Hospital — Yaba, Lagos, Nigeria (Recruiting)
• Obafemi Awolowo University Teaching Hospitals Complex (OAUTHC) — Ile-Ife, Osun State, Nigeria (Recruiting)
• University of Ibadan Hospital — Ibadan, Oyo State, Nigeria (Recruiting)

Study contacts

• Principal investigator: Olufunmilayo Olopade — University of Chicago
• Study coordinator: Olufunmilayo Olopade

Conditions Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; HER2-positive Breast Cancer; Breast Cancer