OncoMatch/Clinical Trials/NCT04993014
Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer
Is NCT04993014 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pertuzumab and Trastuzumab for breast neoplasms.
Treatment: Pertuzumab · Trastuzumab — Phase II unicentric randomized trial which will include early HER2 positive breast cancer patients, candidate to neoadjuvant therapy with trastuzumab and pertuzumab. Circulating tumor cells will be collected at neoadjuvant therapy baseline. Patients with pathological complete response will be randomized in 1:1 ratio for adjuvant trastuzumab (arm A) versus trastuzumab + pertuzumab (arm B) in a two factorial design: group A, with HER2 positive CTCs and group B, with HER2 negative/absent CTCs.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) amplification
HER2 positive breast cancer
Disease stage
Required: Stage I, II, III
Performance status
ECOG 0–3(Limited self-care)
Prior therapy
Must have received: neoadjuvant chemotherapy — neoadjuvant
Indication for neoadjuvant therapy with chemo (any regimen) + trastuzumab + pertuzumab
Must have received: HER2-targeted therapy (trastuzumab, pertuzumab) — neoadjuvant
Indication for neoadjuvant therapy with chemo (any regimen) + trastuzumab + pertuzumab
Must have received: surgery — post-neoadjuvant
Breast surgery after neoadjuvant therapy
Cannot have received: adjuvant chemotherapy
Exception: hormone therapy is allowed
Adjuvant chemotherapy. Hormone therapy is allowed
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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