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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 (May 2026). This Phase 2 trial studies multiple treatments for human epidermal growth factor 2 negative carcinoma of breast.

Phase 2RecruitingUniversity of ChicagoNCT06348134Data as of May 2026

Treatment: Trastuzumab emtansine · Pertuzumab · Docetaxel · Tamoxifen · Letrozole · GoserelinDoctors 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.

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Extracted eligibility criteria

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)

Prior therapy

No prior treatment (treatment-naive required)

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.

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