Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer (HER2Cell)

July 28, 2021 updated by: Marcelle Goldner Cesca, AC Camargo Cancer Center

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • Zedora
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:
  • CTCs
Experimental: Cohort 1, Arm B - Trastuzumab + pertuzumab
Adjuvant trastuzumab + pertuzumab 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:
  • Zedora
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:
  • CTCs
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:
  • Perjeta
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:
  • Zedora
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:
  • CTCs
Experimental: Cohort 2, Arm B - Trastuzumab + pertuzumab
Adjuvant trastuzumab + pertuzumab 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:
  • Zedora
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:
  • CTCs
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:
  • Perjeta

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prognostic factors for disease-free survival
Time Frame: At baseline and adjuvant therapy (18 months)
At baseline and adjuvant therapy (18 months)
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
At baseline
Adverse events
Time Frame: Adjuvant period (1 year)
To compare the adverse events between trastuzumab and trastuzumab + pertuzumab
Adjuvant period (1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AC Camargo Cancer Center

Investigators

  • Principal Investigator: Marcelle G Cesca, MD, A.C. Camargo Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Anticipated)

April 30, 2024

Study Completion (Anticipated)

April 30, 2028

Study Registration Dates

First Submitted

July 21, 2021

First Submitted That Met QC Criteria

July 28, 2021

First Posted (Actual)

August 6, 2021

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

July 28, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2861/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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