Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer

Breast Neoplasms Clinical Trial

— HER2Cell  

Official title:

Circulating Tumor Cells and Adjuvant Treatment De-escalation After Neoadjuvant Therapy With Trastuzumab and Pertuzumab for HER2 Positive Early Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04993014
• Other study ID #: 2861/20
• Status: Recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Breast Neoplasms
• Circulating Tumor Cell
• HER2-positive Breast Cancer
• Neoplastic Cells, Circulating

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)