OncoMatch/Clinical Trials/NCT06348134
Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery
Is NCT06348134 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments for human epidermal growth factor 2 negative carcinoma of breast.
Treatment: Trastuzumab emtansine · Pertuzumab · Docetaxel · Tamoxifen · Letrozole · Goserelin — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Chemotherapy
Endocrine / hormonal
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (positive HER2 status)
histologically confirmed carcinoma of the female breast with positive HER2 status
Required: HER2 (ERBB2) wild-type (HER2-negative disease excluded)
Patients with human epidermal growth factor receptor 2 (HER2-negative) disease
Disease stage
Required: Stage 2A, 2B, 3A, 3B, 3C
Performance status
ECOG 0–3(Limited self-care)
Demographics
Prior therapy
Cannot have received: endocrine therapy (tamoxifen)
Exception: ≤ 4 weeks of tamoxifen for this malignancy; prior tamoxifen or raloxifene for chemoprevention or other past indications allowed if discontinued ≥ 1 month before enrollment
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.
Cannot have received: investigational drug
Participation in any investigational drug study within 4 weeks preceding the start of study treatment
Lab requirements
Blood counts
Granulocyte ≥ 1,500/mL; Platelet count ≥ 100,000/mL; Absolute neutrophil count ≥ 1500/mL; Hemoglobin 10g/dL
Kidney function
Creatinine within institutional normal limits or GFR ≥ 30 mL/min/1.73 m2
Liver function
Bilirubin ≤ 1.5 x upper limit of normal; SGOT and SGPT < 2.5 x upper limit of normal for patients without liver metastases
Cardiac function
Baseline left ventricular ejection fraction of ≥ 55%
Adequate hematologic, renal and hepatic function, as defined by each of the following: Granulocyte ≥ 1,500/mL; Platelet count ≥ 100,000/mL; Absolute neutrophil count ≥ 1500/mL; Hemoglobin 10g/dL; Bilirubin ≤ 1.5 x upper limit of normal; SGOT and SGPT < 2.5 x upper limit of normal for patients without liver metastases; Creatinine within institutional normal limits or GFR ≥ 30 mL/min/1.73 m2; Echocardiogram: Baseline left ventricular ejection fraction of ≥ 55%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06348134 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage 2A or 2B or 3A or 3B or 3C is required.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages