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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04993014
Other study ID # 2861/20
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date March 1, 2021
Est. completion date April 30, 2028

Study information

Verified date July 2021
Source AC Camargo Cancer Center
Contact Marcelle G Cesca, MD
Phone +551121895000
Email marcelle.cesca@accamargo.org.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 80
Est. completion date April 30, 2028
Est. primary completion date April 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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)
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:
Circulating tumor cells
Blood sample collection for examination of CTCs at baseline of neoadjuvant therapy. Tests for HER2 positivity will be done.

Locations

Country Name City State
Brazil A.C. Camargo Cancer Center São Paulo

Sponsors (1)

Lead Sponsor Collaborator
AC Camargo Cancer Center

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary HER2 therapy disease-free survival To compare the disease-free survival between trastuzumab and trastuzumab + pertuzumab arms From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years
Primary CTCs disease-free survival To compare the disease-free survival between patients with HER2 positive CTCs at baseline versus HER2 negative/absent CTCs From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years
Secondary Prognostic factors for disease-free survival At baseline and adjuvant therapy (18 months)
Secondary Correlation of CTCs and pathological complete response To evaluate if there is a correlation of HER2 positivity and the number of CTCs/ml and the pathological response At baseline
Secondary Adverse events To compare the adverse events between trastuzumab and trastuzumab + pertuzumab Adjuvant period (1 year)
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