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

ConditionsBreast NeoplasmsHER2-positive Breast CancerCirculating Tumor Cell
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAC Camargo Cancer Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • 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)

  • 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

  • Circulating tumor cells

    Other intervention

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

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Cohort 1, Arm A - trastuzumabActive comparator 2 interventions
Group B: Cohort 1, Arm B - Trastuzumab + pertuzumabExperimental treatment 3 interventions
Group C: Cohort 2, Arm A - trastuzumabActive comparator 2 interventions
Group D: Cohort 2, Arm B - Trastuzumab + pertuzumabExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

HER2 therapy disease-free survival

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
2

CTCs disease-free survival

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 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

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

Time frame
At baseline
3

Adverse events

To compare the adverse events between trastuzumab and trastuzumab + pertuzumab

Time frame
Adjuvant period (1 year)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AC Camargo Cancer Center

Lead sponsor

Source ClinicalTrials.gov
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