NCT04993014 Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer
| NCT ID | NCT04993014 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | AC Camargo Cancer Center |
| Condition | Breast Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2021-03-01 |
| Primary Completion | 2024-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2021-03-01 with a primary completion date of 2024-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Marcelle G Cesca, MD
PRINCIPAL INVESTIGATOR
A.C. Camargo Cancer Center
Frequently Asked Questions
Who can join the NCT04993014 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04993014 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04993014 currently recruiting?
Yes, NCT04993014 is actively recruiting participants. Contact the research team at marcelle.cesca@accamargo.org.br for enrollment information.
Where is the NCT04993014 trial being conducted?
This trial is being conducted at São Paulo, Brazil.
Who is sponsoring the NCT04993014 clinical trial?
NCT04993014 is sponsored by AC Camargo Cancer Center. The principal investigator is Marcelle G Cesca, MD at A.C. Camargo Cancer Center. The trial plans to enroll 80 participants.