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

Launched by AC CAMARGO CANCER CENTER · Jul 28, 2021

Keywords

ClinConnect Summary

This clinical trial is studying how to tailor treatment for patients with HER2-positive breast cancer after they have received initial therapy. Specifically, it looks at whether patients who have a complete response to neoadjuvant therapy (which means their cancer has significantly shrunk or is undetectable) would benefit more from continuing with trastuzumab alone or adding another drug called pertuzumab. The trial will collect information on circulating tumor cells (CTCs), which are cancer cells that can be found in the blood, to help guide treatment decisions.

To participate in this trial, patients need to be diagnosed with HER2-positive breast cancer at stages I to III and be planning to undergo neoadjuvant therapy that includes chemotherapy along with trastuzumab and pertuzumab. Eligible participants should also have preserved cognitive function and meet specific health criteria. Those who qualify will have their treatment assigned randomly to either continue with trastuzumab alone or with the additional drug, depending on the presence of certain tumor cells. The trial is currently recruiting participants, and it's important for anyone interested to discuss this opportunity with their healthcare provider.

Gender

ALL

Eligibility criteria

• 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