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

Primary Purpose

Breast Neoplasms, HER2-positive Breast Cancer, Circulating Tumor Cell

Status
Recruiting
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Pertuzumab
Trastuzumab
Circulating tumor cells
Sponsored by
AC Camargo Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • A.C. Camargo Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Cohort 1, Arm A - trastuzumab

Cohort 1, Arm B - Trastuzumab + pertuzumab

Cohort 2, Arm A - trastuzumab

Cohort 2, Arm B - Trastuzumab + pertuzumab

Arm Description

Adjuvant trastuzumab for patients with HER2 positive CTCs at baseline

Adjuvant trastuzumab + pertuzumab for patients with HER2 positive CTCs at baseline

Adjuvant trastuzumab for patients with HER2 negative/absent CTCs at baseline

Adjuvant trastuzumab + pertuzumab for patients with HER2 negative/absent CTCs at baseline

Outcomes

Primary Outcome Measures

HER2 therapy disease-free survival
To compare the disease-free survival between trastuzumab and trastuzumab + pertuzumab arms
CTCs disease-free survival
To compare the disease-free survival between patients with HER2 positive CTCs at baseline versus HER2 negative/absent CTCs

Secondary Outcome Measures

Prognostic factors for disease-free survival
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
Adverse events
To compare the adverse events between trastuzumab and trastuzumab + pertuzumab

Full Information

First Posted
July 21, 2021
Last Updated
July 28, 2021
Sponsor
AC Camargo Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT04993014
Brief Title
Circulating Tumor Cells and Treatment De-escalation After Neoadjuvant Therapy for HER2 Positive Breast Cancer
Acronym
HER2Cell
Official Title
Circulating Tumor Cells and Adjuvant Treatment De-escalation After Neoadjuvant Therapy With Trastuzumab and Pertuzumab for HER2 Positive Early Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
April 30, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AC Camargo Cancer Center

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, HER2-positive Breast Cancer, Circulating Tumor Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Model Description
Patients will be divided into 2 cohorts, based on HER2 positivity in CTCs at baseline of neoadjuvant therapy. Cohort 1: HER2 positive CTCs: randomization to adjuvant trastuzumab versus trastuzumab + pertuzumab in patients with pathological complete response Cohort 2: HER2 negative/absent CTCs: randomization to adjuvant trastuzumab versus trastuzumab + pertuzumab in patients with pathological complete response
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1, Arm A - trastuzumab
Arm Type
Active Comparator
Arm Description
Adjuvant trastuzumab for patients with HER2 positive CTCs at baseline
Arm Title
Cohort 1, Arm B - Trastuzumab + pertuzumab
Arm Type
Experimental
Arm Description
Adjuvant trastuzumab + pertuzumab for patients with HER2 positive CTCs at baseline
Arm Title
Cohort 2, Arm A - trastuzumab
Arm Type
Active Comparator
Arm Description
Adjuvant trastuzumab for patients with HER2 negative/absent CTCs at baseline
Arm Title
Cohort 2, Arm B - Trastuzumab + pertuzumab
Arm Type
Experimental
Arm Description
Adjuvant trastuzumab + pertuzumab for patients with HER2 negative/absent CTCs at baseline
Intervention Type
Drug
Intervention Name(s)
Pertuzumab
Other Intervention Name(s)
Perjeta
Intervention Description
Adjuvant trastuzumab + pertuzumab (arm B of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative/absent CTCs at baseline)
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
Zedora
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Circulating tumor cells
Other Intervention Name(s)
CTCs
Intervention Description
Blood sample collection for examination of CTCs at baseline of neoadjuvant therapy. Tests for HER2 positivity will be done.
Primary Outcome Measure Information:
Title
HER2 therapy disease-free survival
Description
To compare the disease-free survival between trastuzumab and trastuzumab + pertuzumab arms
Time Frame
From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years
Title
CTCs disease-free survival
Description
To compare the disease-free survival between patients with HER2 positive CTCs at baseline versus HER2 negative/absent CTCs
Time Frame
From adjuvant therapy initiation to recurrence or death by any cause, whichever came first, assessed up to 5 years
Secondary Outcome Measure Information:
Title
Prognostic factors for disease-free survival
Time Frame
At baseline and adjuvant therapy (18 months)
Title
Correlation of CTCs and pathological complete response
Description
To evaluate if there is a correlation of HER2 positivity and the number of CTCs/ml and the pathological response
Time Frame
At baseline
Title
Adverse events
Description
To compare the adverse events between trastuzumab and trastuzumab + pertuzumab
Time Frame
Adjuvant period (1 year)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marcelle G Cesca, MD
Phone
+551121895000
Email
marcelle.cesca@accamargo.org.br
First Name & Middle Initial & Last Name or Official Title & Degree
Ludmilla TD Chinen, PhD
Phone
+551121895000
Email
ludmilla.chinen@accamargo.org.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelle G Cesca, MD
Organizational Affiliation
A.C. Camargo Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
A.C. Camargo Cancer Center
City
São Paulo
ZIP/Postal Code
01525-001
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcelle G Cesca, MD
Phone
+551121895000
Email
marcelle.cesca@accamargo.org.br
First Name & Middle Initial & Last Name & Degree
Ludmilla TD Chinen, PhD
Phone
+551121895000
Email
ludmilla.chinen@accamargo.org.br

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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