Treatment adjustment for HER2 positive breast cancer after initial therapy
Circulating Tumor Cells and Adjuvant Treatment De-escalation After Neoadjuvant Therapy With Trastuzumab and Pertuzumab for HER2 Positive Early Breast Cancer
This study is testing if adjusting treatment for early HER2 positive breast cancer based on blood tests can help patients do better after their initial therapy.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AC Camargo Cancer Center Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab, chemotherapy |
| Locations | 1 site (São Paulo) |
| Trial ID | NCT04993014 on ClinicalTrials.gov |
What this trial studies
This Phase II unicentric randomized trial focuses on patients with early HER2 positive breast cancer who are candidates for neoadjuvant therapy using trastuzumab and pertuzumab. Blood samples will be collected to analyze circulating tumor cells (CTCs) for HER2 positivity before treatment. Patients who achieve a pathological complete response will be randomized into two groups: one receiving adjuvant trastuzumab alone and the other receiving trastuzumab plus pertuzumab, based on the presence or absence of HER2 positive CTCs. The study aims to evaluate the effectiveness of treatment de-escalation based on CTC analysis.
Who should consider this trial
Good fit: Ideal candidates are patients with HER2 positive breast cancer, stages I to III, who are eligible for neoadjuvant therapy.
Not a fit: Patients with contraindications for trastuzumab or pertuzumab, or those requiring adjuvant chemotherapy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized treatment strategies for patients with HER2 positive breast cancer, potentially reducing unnecessary treatment exposure.
How similar studies have performed: Other studies have explored treatment de-escalation based on biomarker analysis, showing promising results, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
São Paulo
- A.C. Camargo Cancer Center — São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Marcelle G Cesca, MD — A.C. Camargo Cancer Center
- Study coordinator: Marcelle G Cesca, MD
- Email: marcelle.cesca@accamargo.org.br
- Phone: +551121895000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.