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

Study acronym: HER2Cell
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 6, 2021 (before its estimated April 30, 2024 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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 Number NCT04993014
Lead Sponsor AC Camargo Cancer Center
Conditions
(from sponsor)		 Breast Neoplasms, HER2-positive Breast Cancer, Circulating Tumor Cell
Related terms Breast Neoplasms, Neoplastic Cells, Circulating
Enrollment 80 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov