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NCT Number: NCT04993014

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

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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Circulating Tumor Cell HER2-positive Breast Cancer Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pertuzumab

Drug

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: Perjeta

Trastuzumab

Drug

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: Zedora

Circulating tumor cells

Other

Blood sample collection for examination of CTCs at baseline of neoadjuvant therapy. Tests for HER2 positivity will be done.

Other names: CTCs

Primary outcomes

  1. 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

    To compare the disease-free survival between trastuzumab and trastuzumab + pertuzumab arms

  2. 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

    To compare the disease-free survival between patients with HER2 positive CTCs at baseline versus HER2 negative/absent CTCs

Secondary outcomes

  1. Prognostic factors for disease-free survival

    Time frame: At baseline and adjuvant therapy (18 months)

  2. Correlation of CTCs and pathological complete response

    Time frame: At baseline

    To evaluate if there is a correlation of HER2 positivity and the number of CTCs/ml and the pathological response

  3. Adverse events

    Time frame: Adjuvant period (1 year)

    To compare the adverse events between trastuzumab and trastuzumab + pertuzumab

Study contacts

Contact information is provided by the study sponsor or research team.

Ludmilla TD Chinen, PhD

CONTACT

[email protected]

+551121895000

Marcelle G Cesca, MD

CONTACT

[email protected]

+551121895000

Sponsors and collaborators

Lead sponsor

AC Camargo Cancer Center

Other

Registry information

Official study title

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

Acronym: HER2Cell

Important dates

Study start
2021
Primary completion
2024
Study completion
2028
First posted
Aug 6, 2021
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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