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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-01

Study Completion Date

2028-04-30

Brief Summary

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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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Detailed Description

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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

Conditions

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Breast Neoplasms HER2-positive Breast Cancer Circulating Tumor Cell

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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Pertuzumab

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

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

Intervention Type DRUG

Circulating tumor cells

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

Intervention Type OTHER

Other Intervention Names

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Perjeta Zedora CTCs

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No