Metastatic Breast CancerPERPETUALNCT07130344
PERCIST Evaluation of Trastuzumab Deruxtecan in the Treatment of HER2 Low Breast Cancer
A study testing TAP CT-scan, Bone scintigraphy and 18F-FDG PET-CT in people with Metastatic Breast Cancer and HER 2 Low-expressing Breast Cancer, run by Centre Paul Strauss at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, HER 2 Low-expressing Breast Cancer
- What is being tested?
- TAP CT-scan, Bone scintigraphy and 18F-FDG PET-CT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2025to Sep 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Patient (male or female of childbearing potential) using a highly effective contraceptive method
- Women of childbearing potential must have a negative pregnancy test within 72 hours before starting treatment
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- Willingness and ability to comply with the visit schedule, treatment regimens, examinations and other procedures planned in the study
- Patient enrolled in a health insurance plan or beneficiary of such a plan
- Signed informed consent obtained before inclusion (after giving clear, fair and appropriate information)
Who cannot join
- 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
- Ongoing participation in another clinical trial with an investigational treatment
- Pregnant or breastfeeding women
- Persons deprived of their freedom or under guardianship or incapable of giving consent
- Any psychiatric illness/social situation that may limit compliance with study procedures or prevent the patient from giving written informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
ICANS
Strasbourg, 67033
François SOMME, 368766767 ext. 33, f.somme@icans.eu
About this study
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).
Read more
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.
Read the detailed description
Screening period will last 28 days. Each participant will have baseline evaluation by TAP CT-scan, bone scintigraphy and 18F-FDG PET-CT.
After randomization, patient will start T-DXd treatment according to SOC until progression or toxicity. Patient will be followed by TAP CT-scan and bone scintigraphy (SOC arm) or 18F-FDG PET-CT (experimental arm) every 3 months, until progression or new treatment initiation or death or until 2 years whichever occurs first.
- Being tested
- TAP CT-scan, Bone scintigraphy, 18F-FDG PET-CT
- Keywords
- Breast Cancer, 18F-FDG PET-CT, T-DXd
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAP CT-scanProcedure or 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 scintigraphyProcedure or 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-CTProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| SOC arm | Active comparator | Patient will be followed by TAP CT-scan and bone scintigraphy every 3 months, until progression or new treatment initiation or until 2 years whichever occurs first. Receives: Procedure: TAP CT-scan; Procedure: Bone scintigraphy |
| Experimental arm | Experimental | Patient will be followed by 18F-FDG PET-CT every 3 months, until progression or new treatment initiation or until 2 years whichever occurs first. Receives: Procedure: 18F-FDG PET-CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 3 months
Secondary outcomes (5)
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).
Measured: 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.
Time until new therapy initiation
Time from inclusion to initiation of new therapy.
Measured: Until initiation of a new therapy or until 2 years, whichever occurs first.
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.
Measured: From date of inclusion until the date of death or lost to follow-up or until 2 years, whichever occurs first.
Response duration
Time from date of first documented response (complete or partial response) to date of first subsequent progression or death from any cause.
Measured: 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.
Patient Quality of life
Assessment of all dimensions of the European Organization for Research and Treatment of Cancer (EORTC) QLG Core Questionnaire (EORTC QLQ-C30). Difference on specific symptom scales (from 1 = " not at all " to 4 = " very much ", or from 1 = " really bad " to 7 = " excellent ").
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Paul Strauss
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François SOMME, Principal investigator, Institut de cancérologie Strasbourg Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130344
- Sponsor's protocol ID
- 2024-008
- Acronym
- PERPETUAL
- Status last verified
- Sep 2025
- First submitted
- 12 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERCIST Evaluation of Trastuzumab Deruxtecan in the Treatment of HER2 Low Breast Cancer
- ClinicalTrials.gov ID
- NCT07130344
- Acronym / sponsor ID
- PERPETUAL / 2024-008
- Keywords
- Breast Cancer, 18F-FDG PET-CT, T-DXd
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 262 participants (estimated)
- Lead sponsor
- Centre Paul StraussUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Screening period will last 28 days. Each participant will have baseline evaluation by TAP CT-scan, bone scintigraphy and 18F-FDG PET-CT.
After randomization, patient will start T-DXd treatment according to SOC until progression or toxicity. Patient will be followed by TAP CT-scan and bone scintigraphy (SOC arm) or 18F-FDG PET-CT (experimental arm) every 3 months, until progression or new treatment initiation or death or until 2 years whichever occurs first.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SOC arm | Active comparator | Procedure: TAP CT-scan, Procedure: Bone scintigraphyPatient will be followed by TAP CT-scan and bone scintigraphy every 3 months, until progression or new treatment initiation or until 2 years whichever occurs first. |
| Experimental arm | Experimental | Procedure: 18F-FDG PET-CTPatient will be followed by 18F-FDG PET-CT every 3 months, until progression or new treatment initiation or until 2 years whichever occurs first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
- Patient (male or female of childbearing potential) using a highly effective contraceptive method
Key exclusion criteria (8 listed)
- 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
- Ongoing participation in another clinical trial with an investigational treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAP CT-scanPatient 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. | Procedure or surgery | SOC arm |
| Bone scintigraphyPatient 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. | Procedure or surgery | SOC arm |
| 18F-FDG PET-CTPatient 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. | Procedure or surgery | Experimental arm |
Primary outcome
Objective response rate
Time frame: at 3 months
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.
5 secondary outcomes
Progression-free survival
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.
Time until new therapy initiation
Time frame: Until initiation of a new therapy or until 2 years, whichever occurs first.
Overall survival
Time frame: From date of inclusion until the date of death or lost to follow-up or until 2 years, whichever occurs first.
Response duration
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.
Patient Quality of life
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
François SOMME principal investigator
Institut de cancérologie Strasbourg Europe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TAP CT-scan, Bone scintigraphy and 18F-FDG PET-CT in people with Metastatic Breast Cancer and HER 2 Low-expressing Breast Cancer, run by Centre Paul Strauss at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Valérie SARTORI (368767223 ext. 33, v.sartori@icans.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.