HER2Cell: Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
Patients with HER2 positive breast cancer (hormone receptors positive or negative), which are candidate to neoadjuvant therapy with pertuzumab and trastuzumab will be included.
Blood samples will be collected at baseline (before neoadjuvant start) for the analysis of CTCs and its positivity for HER2 by IHC and ISH.
Patients with pathological complete response will be included in the randomization phase of the study. There will be 2 cohorts: HER2 positive CTCs at baseline and HER2 negative/absent CTCs at baseline. In each cohort, patients will be randomized in 1:1 ratio for adjuvant trastuzumab versus adjuvant trastuzumab + pertuzumab
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Cohort 1, Arm A - trastuzumab Adjuvant trastuzumab for patients with HER2 positive CTCs at baseline |
Drug: Trastuzumab
Adjuvant trastuzumab (arm A of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative/absent CTCs at baseline) Association with pertuzumab in arm B of the 2 cohorts
Other Names:
Other: Circulating tumor cells
Blood sample collection for examination of CTCs at baseline of neoadjuvant therapy. Tests for HER2 positivity will be done.
Other Names:
|
| Experimental: Cohort 1, Arm B - Trastuzumab + pertuzumab Adjuvant trastuzumab + pertuzumab for patients with HER2 positive CTCs at baseline |
Drug: Pertuzumab
Adjuvant trastuzumab + pertuzumab (arm B of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative/absent CTCs at baseline)
Other Names:
Drug: Trastuzumab
Adjuvant trastuzumab (arm A of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative/absent CTCs at baseline) Association with pertuzumab in arm B of the 2 cohorts
Other Names:
Other: Circulating tumor cells
Blood sample collection for examination of CTCs at baseline of neoadjuvant therapy. Tests for HER2 positivity will be done.
Other Names:
|
| Active Comparator: Cohort 2, Arm A - trastuzumab Adjuvant trastuzumab for patients with HER2 negative/absent CTCs at baseline |
Drug: Trastuzumab
Adjuvant trastuzumab (arm A of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative/absent CTCs at baseline) Association with pertuzumab in arm B of the 2 cohorts
Other Names:
Other: Circulating tumor cells
Blood sample collection for examination of CTCs at baseline of neoadjuvant therapy. Tests for HER2 positivity will be done.
Other Names:
|
| Experimental: Cohort 2, Arm B - Trastuzumab + pertuzumab Adjuvant trastuzumab + pertuzumab for patients with HER2 negative/absent CTCs at baseline |
Drug: Pertuzumab
Adjuvant trastuzumab + pertuzumab (arm B of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative/absent CTCs at baseline)
Other Names:
Drug: Trastuzumab
Adjuvant trastuzumab (arm A of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative/absent CTCs at baseline) Association with pertuzumab in arm B of the 2 cohorts
Other Names:
Other: Circulating tumor cells
Blood sample collection for examination of CTCs at baseline of neoadjuvant therapy. Tests for HER2 positivity will be done.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- HER2 therapy disease-free survival [From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years]
To compare the disease-free survival between trastuzumab and trastuzumab + pertuzumab arms
- CTCs disease-free survival [From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years]
To compare the disease-free survival between patients with HER2 positive CTCs at baseline versus HER2 negative/absent CTCs
Secondary Outcome Measures
- Prognostic factors for disease-free survival [At baseline and adjuvant therapy (18 months)]
- Correlation of CTCs and pathological complete response [At baseline]
To evaluate if there is a correlation of HER2 positivity and the number of CTCs/ml and the pathological response
- Adverse events [Adjuvant period (1 year)]
To compare the adverse events between trastuzumab and trastuzumab + pertuzumab
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | A.C. Camargo Cancer Center | São Paulo | Brazil | 01525-001 |
Sponsors and Collaborators
- AC Camargo Cancer Center
Investigators
- Principal Investigator: Marcelle G Cesca, MD, A.C. Camargo Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2861/20