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Decreasing Treatment for Metastatic HER2-Positive Breast Cancer With Undectable Cancer Levels in Blood Tests.

ConditionsMetastatic Breast CancerHER2-positive Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUNICANCER

About this trial

Heroes is a multicentre, national, non-randomized, open-label, phase 2 study. The goal of this clinical trial is to evaluate the feasibility of therapeutic de-escalation in HER2-positive metastatic breast cancer with disease controlled after 2 years of maintenance treatment with anti-HER2 targeted therapy AND ctDNA negative testing.

The main question it aims to answer is :

• Is it possible to identify patients for whom temporary or permanent discontinuation of treatment is possible without impacting prognosis?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in signing the patient's consent;

Men or women ≥18 years of age;

Documented diagnosis of locally advanced inoperable or metastatic histologically-proven HER2-positive breast cancer (HER2-positive is defined as HER2 3+ immunohistochemical overexpression, or the presence of HER2 amplification, according to ASCO-CAP guidelines);

Must have an adequate archival tumor tissue sample available for next-generation sequencing (NGS) analysis by central laboratory, in order to design the ctDNA test (based on most recent available tumor tissue sample, metastatic biopsy (bone tissue excluded) and primary tumor authorised);

Disqualifiers

Any breast cancer progression over the past 2 years or at study entry;

Patient concurrently using other approved or investigational antineoplastic agents than trastuzumab, pertuzumab, Trastuzumab-Deruxtecan, TDM-1 +/- endocrine therapy;

Had an history of tumoral meningitis or clinically active central nervous system metastases, defined as untreated or symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms;

Subjects with curatively treated brain metastases (i.e., complete removal surgery or stereotactic radiotherapy) who are no longer symptomatic and do not require treatment with corticosteroids or anticonvulsants may be included in the study provided they have recovered from the acute toxicity of radiotherapy and there has been no progression of the brain metastases within the past 24 months.

Trial design

Design model

Single group

Treatments tested in this trial

  • Discontinuation of the anti-HER2 maintenance therapy

    Drug

    Heroes is a de-escalation study. Patient must have received continuous anti-HER2 targeted therapy (including Trastuzumab, Trastuzumab/Pertuzumab, Trastuzumab-Deruxtecan, T-DM1) for at least 2 years in any line setting for their HER2-positive metastatic breast cancer with complete response or partial response at last radiological assessment. Patients with ctDNA negative test at baseline will stop their anti-HER2 targeted therapy during the study

  • Monitoring with signatera test

    Device

    ctDNA test will be performed at 1.5 month after inclusion and every 3 months during 2 years. Note: For the ctDNA negative patients who become ctDNA positive: ctDNA test will be performed once, 3 months after restarting treatment (+/-1 week).

Treatment groups

170 Participants
are divided into 1 treatment group
Group A: ctDNA negative cohort at baselineExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Progression-free rate

The progression-free rate (PFR) is the percentage of patient with disease progression defined as the time from the date of registration to the date of the first documented event among radiological progressions (RECIST 1.1), molecular progressions definitive as ctDNA-positive results, or death due to any cause, whichever occurs first.

Time frame
1 year

Secondary outcomes

1

Progression-free survival

Progression-free survival (PFS) is defined as the time from the date of registration to the date of the first documented cancer progression measured by RECIST 1.1 or death due to any cause, whichever occurs first.

Time frame
1 year
2

ctDNA dynamics

The ctDNA dynamics is defined as changes in the level of ctDNA (from negative to positive) during the surveillance phase.

Time frame
1 year
3

ctDNA positivity rate

Positivity rate is defined as the proportion of patients with positive ctDNA results.

Time frame
1 year
4

Overall Survival

Overall Survival (OS) is defined as the time from the date of registration to the date of death due to any cause

Time frame
1 year

Other outcomes

Sponsors and contacts

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

UNICANCER

Lead sponsor

Natera, Inc.

Collaborator

Source ClinicalTrials.gov
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