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Recruiting NCT04993014

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

Phase II Interventional Breast Neoplasms HER2-positive Breast Cancer Circulating Tumor Cell

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pertuzumab, Trastuzumab, Circulating tumor cells.
Who it may be relevant to
Registry conditions: Breast Neoplasms, HER2-positive Breast Cancer, Circulating Tumor Cell. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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

Interventions

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

Primary outcome measures

  • HER2 therapy disease-free survival [Time frame: From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years]
  • CTCs disease-free survival [Time frame: From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years]
Secondary outcome measures (3)
  • Prognostic factors for disease-free survival [Time frame: At baseline and adjuvant therapy (18 months)]
  • Correlation of CTCs and pathological complete response [Time frame: At baseline]
  • Adverse events [Time frame: Adjuvant period (1 year)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Factorial
Masking
Open label
Primary purpose
Treatment

Study locations

Brazil · 1 center
  • A.C. Camargo Cancer Center — São Paulo

Identifiers

NCT: NCT04993014 · 2861/20

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗