HER2-positive Breast CancerREVERNCT03619044
The Use of FES-PET Imaging as a Tool to Detect a Possible Reversion of Estrogen Receptor (ER)-α Status in Patients With Metastatic Breast Cancer HER2 + and ERα Neg Treated With Trastuzumab + Pertuzumab + Taxane.
A study testing 2 FES-PET Imaging will be performed: in people with HER2-positive Breast Cancer, run by Institut Claudius Regaud at 6 sites in France.
Trial summary
This is an exploratory, prospective and multicentric study aiming to highlight by FES-PET imaging that an anti-HER2 treatment by trastuzumab + pertuzumab can reverse the ERα status in patients with metastatic breast cancer HER2 + and ERα neg. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- 2 FES-PET Imaging will be performed:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 6 sitesFrance
- Study dates
- 28 Aug 2020to 9 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Patient with metastatic breast cancer HER2 + (IHC+++ and/or HER2 amplification in ISH according to ASCO recommendations), ERα neg (0% in IHC) and Progesterone Receptor neg (0% in IHC).
- Patient eligible according to the investigator for a treatment with trastuzumab + pertuzumab + taxane in the metastatic first line.
- Available biopsy of a tumor lesion (archived material) or biopsiable tumor lesion for study (primitive tumor or metastasis other than bone).
- OMS ≤ 2.
- For non-menopausal patients, use of an effective contraceptive method at entry into the study and for the duration of the study.
- Patient affiliated to a Social Health Insurance in France.
- Patient must provide written informed consent prior to any study specific procedures.
Who cannot join
- Any previous treatment for metastatic disease.
- Prior adjuvant treatment with anti-HER2 antibodies taken within 6 months.
- Patient with isolated hepatic metastasis.
- Patient with hemostasis disorders.
- Unbalanced Diabetes.
- Patient with usual formal contraindication to PET/TDM Imaging.
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- Patient who has already started trastuzumab + pertuzumab + taxane treatment.
- Pregnant or breastfeeding women.
- Any psychological, familial, geographical or sociological condition which does not allow to respect the medical follow-up and/or compliance to study procedure.
- Patient protected by law.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Clinique Claude Bernard
Albi, 81000
Centre Hospitalier Auch
Auch, 32008
Clinique Capio La Croix Du Sud
Quint-Fonsegrives, 31130
Centre Hospitalier de Rodez
Rodez, 12000
IUCT-O
Toulouse, 31059
Clinique Pasteur
Toulouse, 31076
About this study
This is an exploratory, prospective and multicentric study aiming to highlight by FES-PET imaging that an anti-HER2 treatment by trastuzumab + pertuzumab can reverse the ERα status in patients with metastatic breast cancer HER2 + and ERα neg.
For each included patient, 2 FES-PET Imaging will be performed for the study (before cancer treatment initiation and before the cycle 3 of treatment) at the IUCT-O center (Institut Universitaire du Cancer de Toulouse).
Treatment (trastuzumab + pertuzumab + taxane) will be administered according to the current recommendations in each participant center.
Patients will be followed during the 3 cycles of treatment.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- 2 FES-PET Imaging will be performed:
- Keywords
- Metastatic breast cancer, FES-PET, HER2-positive Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 FES-PET Imaging will be performed:Other
- before treatment initiation
- before treatment cycle 3 initiation
| Study group | Role | What they receive |
|---|---|---|
| Patients with metastatic breast cancer | Other | Patients with metastatic breast cancer treated with trastuzumab + pertuzumab + taxane in the metastatic first line. Receives: Other: 2 FES-PET Imaging will be performed: |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients with conversion of FES negative lesions in FES positive lesions.
Measured: Cycle 3 Day 1 for each patient.
Secondary outcomes (2)
The rate of patients with FES positive lesions before treatment.
Measured: Cycle 4 Day 1 for each patient.
The adverse events due to FES-PET imaging evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Measured: Cycle 4 Day 1 for each patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start28 Aug 2020
- Primary completion11 Jun 2021
- Study completion9 Jul 2021
Why it stopped: Slow recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Claudius Regaud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619044
- Sponsor's protocol ID
- 18 SEIN 08
- Acronym
- REVER
- Status last verified
- Jan 2022
- First submitted
- 1 Aug 2018
- Last updated
- 10 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of FES-PET Imaging as a Tool to Detect a Possible Reversion of Estrogen Receptor (ER)-α Status in Patients With Metastatic Breast Cancer HER2 + and ERα Neg Treated With Trastuzumab + Pertuzumab + Taxane.
- ClinicalTrials.gov ID
- NCT03619044
- Acronym / sponsor ID
- REVER / 18 SEIN 08
- Conditions
- HER2-positive Breast Cancer
- Keywords
- Metastatic breast cancer, FES-PET, HER2-positive Breast Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment rate
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Institut Claudius RegaudUniversity, hospital or other
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 11 Jun 2021 (actual)
- Study completion
- 9 Jul 2021 (actual)
- First posted
- 7 Aug 2018 (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.
This is an exploratory, prospective and multicentric study aiming to highlight by FES-PET imaging that an anti-HER2 treatment by trastuzumab + pertuzumab can reverse the ERα status in patients with metastatic breast cancer HER2 + and ERα neg.
For each included patient, 2 FES-PET Imaging will be performed for the study (before cancer treatment initiation and before the cycle 3 of treatment) at the IUCT-O center (Institut Universitaire du Cancer de Toulouse).
Treatment (trastuzumab + pertuzumab + taxane) will be administered according to the current recommendations in each participant center.
Patients will be followed during the 3 cycles of treatment.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with metastatic breast cancer | Other | Other: 2 FES-PET Imaging will be performed:Patients with metastatic breast cancer treated with trastuzumab + pertuzumab + taxane in the metastatic first line. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years.
- Patient with metastatic breast cancer HER2 + (IHC+++ and/or HER2 amplification in ISH according to ASCO recommendations), ERα neg (0% in IHC) and Progesterone Receptor neg (0% in IHC).
- Patient eligible according to the investigator for a treatment with trastuzumab + pertuzumab + taxane in the metastatic first line.
- Available biopsy of a tumor lesion (archived material) or biopsiable tumor lesion for study (primitive tumor or metastasis other than bone).
- OMS ≤ 2.
Key exclusion criteria (10 listed)
- Any previous treatment for metastatic disease.
- Prior adjuvant treatment with anti-HER2 antibodies taken within 6 months.
- Patient with isolated hepatic metastasis.
- Patient with hemostasis disorders.
- Unbalanced Diabetes.
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 |
|---|---|---|
| 2 FES-PET Imaging will be performed:* before treatment initiation * before treatment cycle 3 initiation | Other | Patients with metastatic breast cancer |
Primary outcome
The rate of patients with conversion of FES negative lesions in FES positive lesions.
Time frame: Cycle 3 Day 1 for each patient.
2 secondary outcomes
The rate of patients with FES positive lesions before treatment.
Time frame: Cycle 4 Day 1 for each patient.
The adverse events due to FES-PET imaging evaluated by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Time frame: Cycle 4 Day 1 for each patient.
Results and safety
The study was stopped early (reason given: Slow recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2 FES-PET Imaging will be performed: in people with HER2-positive Breast Cancer, run by Institut Claudius Regaud at 6 sites 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 8 inclusion and 10 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: stopped early, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study was stopped early (reason given: Slow recruitment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of patients with conversion of FES negative lesions in FES positive lesions. (time frame: Cycle 3 Day 1 for each patient.). 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 Feb 2022.