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.

Trial Details

NCT ID
NCT04993014
Phase
PHASE2
Sponsor
AC Camargo Cancer Center
Status
RECRUITING
Cancer Type
HER2 Positive Breast Cancer
Interventions
  • Pertuzumab
  • Trastuzumab
  • Circulating tumor cells
Locations (sample)
  • São Paulo, Brazil|-23.5475,-46.63611

Key Eligibility 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

For full eligibility, visit ClinicalTrials.gov.

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