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PERCIST Evaluation of Trastuzumab Deruxtecan in the Treatment of HER2 Low Breast Cancer

ConditionsMetastatic Breast CancerHER 2 Low-expressing Breast Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Paul Strauss

About this trial

The development of trastuzumab deruxtecan (T-DXd), an anti-HER2 conjugated antibody, has changed the therapeutic landscape of breast cancer. Anti-HER2 molecules were previously used exclusively in cases of HER2-positive breast cancer (IHC HER2 3+ or HER2 2+ with amplified FISH/SISH).

Since a couple of years, T-DXd is becoming a reference treatment in patients with low HER2 breast cancer (IHC 1+ or 2+ with non-amplified FISH/SISH) after hormone therapy and at least one line of chemotherapy. The results of the DB04 trial revealed that T-DXd increased progression-free survival and overall survival compared to investigator's choice chemotherapy, in HER2 low breast cancers patients after one or two previous lines of chemotherapy (Modi, S. et al., 2022).

In several trials, T-DXd validation was done thanks to radiological evaluation based on conventional imaging, computed tomography scan (CT-scan) with or without contrast dye injection and bone scintigraphy.

18F-Fluorodeoxyglucose positron emission tomography coupled with computed tomography (18F-FDG PET-CT) represents a major tool for diagnosis, staging, and therapeutic follow-up in oncology.

It was demonstrated that 18F-FDG PET-CT is more sensitive in detecting metastatic disease progression in HER2-positive breast cancer patients treated with trastuzumab and pertuzumab or trastuzumab and lapatinib (Ma, G. et al., 2023 et Lin, N. U. et al., 2015). Moreover, a prospective study investigated the correlation between the response rate defined by 18F-FDG PET-CT and thoraco-abdomino-pelvic CT-scan (TAP CT-scan) and the progression-free survival of patients with breast cancer. PET evaluation allowed better identification of responders versus non-responders, with a significant correlation with progression-free survival (Vogsen, M. et al., 2023).

With this study, the investigators aim to determine the role of 18F-FDG PET-CT in evaluating T-DXd treatment in patients with metastatic low HER2 breast cancer. 18F-FDG PET-CT could be an earlier evaluation tool than CT-scan in identifying non-responsive patients; and thus, avoid continuing an expensive treatment with an unfavorable toxicity profile, which could worsen both patient prognosis and quality of life.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age greater than or equal to 18 years at inclusion

Cytological or histological confirmation of the diagnosis of low HER2 breast cancer (IHC 1+ or 2+ with non-amplified FISH/SIS)

Metastatic disease according to RECIST 1.1

Indication of T-DXd treatment

Disqualifiers

Allergy to contrast dye

Contra-indication to PET-CT

Any active infection or uncontrolled intercurrent pathology

Patient with a life expectancy lower than 3 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • TAP CT-scan

    Procedure/Surgery

    Patient in the SOC arm will be followed by TAP CT-scan every 3 months, until progression or new treatment initiation or until 2 years whichever occurs first.

  • Bone scintigraphy

    Procedure/Surgery

    Patient in the SOC arm will be followed by bone scintigraphy every 3 months, until progression or new treatment initiation or until 2 years whichever occurs first.

  • 18F-FDG PET-CT

    Procedure/Surgery

    Patient in the experimental arm will be followed by 18F-FDG PET-CT every 3 months, until progression or new treatment initiation or until 2 years whichever occurs first.

Treatment groups

262 Participants
are divided into 2 treatment groups
Group A: SOC armActive comparator 2 interventions
Group B: Experimental armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate

Radiological response according to PERCIST 1.0 criteria in experimental arm and RECIST 1.1 criteria in SOC arm. Number of patients who had an objective response at 3 months in both arms. The evaluation is carried out by the investigator.

Time frame
at 3 months

Secondary outcomes

1

Progression-free survival

Progression events will be collected (progression according to PERCIST 1.0 criteria in experimental arm and RECIST 1.1 criteria in SOC arm or death whatever the cause).

Time frame
Every 3 months until the date of first documented progression or new therapy initiation or date of death or until 2 years, whichever occurs first.
2

Time until new therapy initiation

Time from inclusion to initiation of new therapy.

Time frame
Until initiation of a new therapy or until 2 years, whichever occurs first.
3

Overall survival

The patient's condition (alive, deceased from whatever cause or lost to follow-up) will be collected. Patients alive at the time of analysis will be censored on the date of last contact.

Time frame
From date of inclusion until the date of death or lost to follow-up or until 2 years, whichever occurs first.
4

Response duration

Time from date of first documented response (complete or partial response) to date of first subsequent progression or death from any cause.

Time frame
Every 3 months until the date of first documented progression or new therapy initiation or date of death or until 2 years, whichever occurs first.

Other outcomes

Sponsors and contacts

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

Centre Paul Strauss

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: