Clinical trial · Interventional
Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer
Circulating Tumor Cells and Adjuvant Treatment De-escalation After Neoadjuvant Therapy With Trastuzumab and Pertuzumab for HER2 Positive Early Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Circulating Tumor Cell | — | UNRESOLVED | — |
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Circulating tumor cells | Other | — | UNRESOLVED |
| Pertuzumab | Drug | Pertuzumab | ALIAS |
| Trastuzumab | Drug | Trastuzumab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Cohort 1, Arm A - trastuzumab
- description
- Adjuvant trastuzumab for patients with HER2 positive CTCs at baseline
- interventionNames
- Drug: Trastuzumab
- Other: Circulating tumor cells
- type
- EXPERIMENTAL
- label
- Cohort 1, Arm B - Trastuzumab + pertuzumab
- description
- Adjuvant trastuzumab + pertuzumab for patients with HER2 positive CTCs at baseline
- interventionNames
- Drug: Pertuzumab
- Drug: Trastuzumab
- Other: Circulating tumor cells
- type
- ACTIVE_COMPARATOR
- label
- Cohort 2, Arm A - trastuzumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available