Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAC Camargo Cancer Center
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Pertuzumab
- Trastuzumab
- Circulating tumor cells
Treatment groups
80 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov