Recruiting

Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer

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.

ClinicalTrials.gov IDNCT04993014

PhasePHASE2

Enrollment80

SponsorAC Camargo Cancer Center

Age18 Years and older

SexALL

I'm interested View official listing

Conditions studied

Breast Neoplasms, HER2-positive Breast Cancer, Circulating Tumor Cell

About this study

Interventions

Drug: Pertuzumab — Adjuvant trastuzumab + pertuzumab (arm B of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative/absent CTCs at baseline)
Drug: Trastuzumab — Adjuvant trastuzumab (arm A of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative/absent CTCs at baseline) Association with pertuzumab in arm B of the 2 cohorts
Other: Circulating tumor cells — Blood sample collection for examination of CTCs at baseline of neoadjuvant therapy. Tests for HER2 positivity will be done.

Primary outcomes

HER2 therapy disease-free survival (From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years)
CTCs disease-free survival (From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years)

Eligibility information

Inclusion Criteria: * HER2 positive breast cancer (hormone receptors positive or negative) * Stage I to III * Indication for neoadjuvant therapy with chemo (any regimen) + trastuzumab + pertuzumab * Breast surgery after neoadjuvant therapy * Preserved coagnition * ECOG 0-3 * For the randomization phase: pathological complete response (ypT0/ypTis and ypN0) * Agreement on participation and signature of de ICF Exclusion Criteria: * Contradindication for trastuzumab or pertuzumab * Adjuvant chemotherapy. Hormone therapy is allowed * Second primary tumor \< 5 years, with an exception for treated non-melanoma skin cancer, and in situ cervical cancer

Study locations

A.C. Camargo Cancer Center, São Paulo, 01525-001 Brazil

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-14.