HER2-positive Breast CancerHERdi PREDICTNCT04288141
A Study to Measure the Expression of the HER2-HER3 Dimer in Tumour and Blood (Exosomes) Samples From Patients With HER2 Positive Breast Cancer Receiving HER2 Targeted Therapies
An observational study of HER2-positive Breast Cancer, run by King's College London at 2 sites in United Kingdom.
Trial summary
The treatment of breast cancer is determined by its 'receptor (or signal) status'. Receptors are signals present on all cells and if abnormal can drive cancer growth. One of the signals that can drive breast cancer growth is the HER2 receptor/signal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- Acquisition of blood samples and tumour tissue samples (biopsies)
- How many people
- 40 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 20 Dec 2019to Jun 2023
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Group 1: Early HER2 positive breast cancer and prescribed neoadjuvant chemotherapy including trastuzumab and pertuzumab as per physician discretion. Group 2: Metastatic HER2 positive breast cancer and prescribed chemotherapy including trastuzumab and pertuzumab as per physician discretion.
Who may be able to join
- Female or Male aged 18 years or above.
- Histologically documented breast cancer. In participants with metastatic breast cancer (Group 2), the biopsy should have been obtained following or at the time of diagnosis of metastatic breast cancer. (refer to inclusion criteria 10 for group 2 specific criteria)
- HER2 positive breast cancer, to be established by immunohistochemistry and confirmed by fluorescence in situ hybridisation or dual in situ hybridisation in borderline cases as per standard of care guidelines.
- Confirmation of availability of sufficient tumour tissue (from diagnostic core biopsy) for biomarker analysis (Refer to study laboratory manual)
- Fit for treatment with chemotherapy in combination with HER2 targeted therapy as per investigator discretion
- Life expectancy of 12 weeks or more.
Show all 12Show fewer
- Participant is willing and able to give informed consent for participation in the study and in the investigator's opinion, is able and willing to comply with all study requirements.
- Participant willing to undergo additional biopsies when required i.e. Group 1A and Group 2
- Willing to allow his or her general practitioner to be notified of participation in the study [optional].
- Group 2 specific criteria
- The pre-treatment tumour sample for biomarker analysis in group 2 will be acquired from the diagnostic biopsy acquired when participants were first diagnosed with metastatic HER2 positive breast cancer. The biopsy should have been acquired following or at the time of the diagnosis of metastatic breast cancer (i.e. cannot use tumour tissue acquired during a prior diagnosis of early/locally advanced breast cancer for this study's biomarker analysis). The biopsy may be acquired from a breast mass or a metastatic site. If a biopsy following or at the time of the diagnosis of metastatic breast cancer has not been carried out, a study specific biopsy will need to be organised.
- Only patients recommended first line treatment with a taxane, trastuzumab and pertuzumab by their physician, are eligible. Potential participants being considered for treatment with any other treatment combinations with HER2 targeted therapies will not be considered eligible.
Who cannot join
- Significant thrombocytopaenia or abnormal clotting screen or any other condition that would contraindicate a tissue biopsy if this were required, in the investigator's opinion.
- Participant unwilling to undergo study required tissue biopsies and blood sampling.
- Any other significant underlying condition or comorbidity which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study or the participant's ability to participate in the study.
- Inability of participant to co-operate with study procedures as judged by the investigator.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Brighton and Sussex University Hospitals NHS Trust
Brighton, BN2 5BB
- Recruiting
Guy's Cancer Centre, Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT
Louisa McDonald, 0207 188 2007, Louisa.McDonald@gstt.nhs.uk
About this study
Official title: HERdi PREDICT: A Pilot Study to Measure the Expression of the HER2-HER3 Dimer in Samples From Patients With HER2 Positive Breast Cancer Receiving HER2 Targeted Therapies
The treatment of breast cancer is determined by its 'receptor (or signal) status'. Receptors are signals present on all cells and if abnormal can drive cancer growth. One of the signals that can drive breast cancer growth is the HER2 receptor/signal. One quarter of all breast cancers are found to have too many HER2 signals i.e. HER2-positive breast cancer.
HER2 is a member of the HER-family which constitutes HER1,HER2,HER3,and HER4 signals. Currently, tests can identify breast cancers with too much HER2, from a biopsy, so a cancer doctor can prescribe anti-HER2 treatment to block these signals. These drugs have improved survival rates in HER2-positive breast cancer. Members of the HER family can also 'pair' with each other to activate signals that encourage cancer growth. For example, HER3 naturally 'pairs' with HER2. Though anti-cancer drugs have been developed to target this pairing, the current method of patient selection is not developed to detect pairing of signals in tissue biopsies. A specialist imaging technique called FLIM-FRET (FLIM- Fluorescence Lifetime Imaging Microscopy; FRET- Forster resonance energy transfer) can identify signal pairing on cancer cells from tissue, and potentially, from blood samples.
This study involves having blood tests while participants receive anti-HER2 treatment. The investigators will also seek permission to take samples of cancer tissue from the biopsies that were already carried out, e.g. at diagnosis. Some participants may need an additional biopsy, which will be discussed with participants prior to consent. This study will use the specialist FLIM-FRET technique to measure the signal pairing in tumour samples and blood samples. Investigators will measure if the levels of signal pairing from blood are the same as that from tissue, which could lead to bloods tests being used to select patients for anti-HER2 treatments, instead of invasive tissue biopsies. Changes in signal pairing may also help to predict if a cancer is becoming resistant to treatment.
Read the detailed description
The study will recruit 40 participants to two groups as outlined below:
Group 1: Early HER2 positive breast cancer (20 patients) Group 2: Metastatic HER2 positive breast cancer (20 patients)
The two groups represent the natural spectrum of breast cancer in its clinical presentation.
GROUP 1: EARLY BREAST CANCER
Group 1 will include patients with early HER2 positive breast cancer recommended to receive neo-adjuvant chemotherapy inclusive of HER2 directed therapy (trastuzumab + pertuzumab), prior to proceeding to curative surgery. All participants are expected to have had a diagnostic core biopsy and definitive breast surgery on completion of neoadjuvant chemotherapy as standard of care. Blood samples will be obtained for biomarker analysis in exosomes. Participants in Group 1 A will be requested to have a biopsy on completion of anthracycline based chemotherapy and prior to commencing on HER2-directed therapy.
Group 1 A: Participants in Group 1 commencing treatment with anthracycline based chemotherapy for up to 4 cycles followed by a switch in treatment to taxane based chemotherapy in combination with HER2 directed therapy (trastuzumab + pertuzumab) for up to 4 cycles
Group 1 B: Participants in Group 1 commencing treatment with taxane based systemic therapy in combination with HER2 directed therapy (trastuzumab + pertuzumab) for up to 6 cycles:
GROUP 2: METASTATIC BREAST CANCER:
Group 2 will include patients will include participants recommended commencing any line of palliative systemic therapy inclusive of a HER2 directed therapy by their treating oncologist. All participants are expected to have had a diagnostic core biopsy. Blood samples will be obtained for biomarker analysis in exosomes.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- Acquisition of blood samples and tumour tissue samples (biopsies)
- Keywords
- FLIM-FRET, HER2-HER3 dimer, Exosomes, Predictive biomarkers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acquisition of blood samples and tumour tissue samples (biopsies)Other
Acquisition of blood samples and tumour tissue samples (biopsies) in a sequential manner as participants proceed through HER2-directed therapy as prescribed by their oncologist.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Early HER2 positive breast cancer | Study participants in Group 1 will include patients prescribed neoadjuvant systemic therapy (including trastuzumab and pertuzumab) by their treating oncologist for a diagnosis of HER2 positive early breast cancer. Receives: Other: Acquisition of blood samples and tumour tissue samples (biopsies) | |
| Group 2: Metastatic HER2 positive breast cancer | Study participants in Group 2 will include patients prescribed systemic therapy (including trastuzumab and pertuzumab) by their treating oncologist for a diagnosis of HER2 positive metastatic breast cancer. Receives: Other: Acquisition of blood samples and tumour tissue samples (biopsies) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare HER2-HER3 dimer expression as detected by FLIM-FRET (% positive for HER2-HER3 dimer expression with FRET efficiency ≥8.56%) to HER2 over-expression (% positive for HER2 over-expression by IHC ± FISH) in patient-derived tumour samples.
Measured: Group 1: Baseline biopsy and definitive surgical specimen. Group 2: Baseline biopsy.
Secondary outcomes (9)
Describe the range of FRET efficiency determined by measuring tumoural HER2-HER3 dimerisation as a continuous variable.
Measured: Group 1: Baseline biopsy and definitive surgical specimen. Group 2: Baseline biopsy.
Compare the HER2-HER3 dimer expression level in tumour samples to matched blood samples (exosomal expression) as detected by FLIM-FRET.
Measured: Each cycle (C) is 21 days (D). Group 1A & Group 1B: Baseline biopsy,definitive surgical specimen and paired blood samples. Group 1A: Also in matched interim tumour and blood sample (C4 D14-21). Group 2: Baseline biopsy and blood sample
Compare HER2 expression in blood samples (exosomes) by protein detection assays e.g. dot blots to HER2 status in matched tumour tissue as determined by IHC ± FISH.
Measured: Each cycle (C) is 21 days (D). In group1 HER2 expression in matched participant tumour tissue and blood will be compared at baseline and immediately after completion of neoadjuvant therapy/surgery. In Group 2, to be assessed at baseline only.
Determine the range of measurable exosomal FRET efficiency determined by measuring exosomal HER2-HER3 dimer expression.
Measured: Each cycle (C) is 21 days (D). In group1a: Baseline, C2 D1, C5 D1, C6 D1 and C8 D21-42. In Group 1b: Baseline, C2 D1, C6 D21-42, Group 2: Baseline, C2 D1, C4/5 D1.
Determine if patient derived tumour and blood samples (exosomes) demonstrate a change in HER2-HER3 dimer expression in response to systemic HER2-directed therapy (% positive for change in HER2-HER3 dimer expression).
Measured: Each cycle (C) is 21 days (D). In group1a: Baseline, C2 D1, C5 D1, C6 D1 and C8 D21-42. In Group 1b: Baseline, C2 D1, C6 D21-42, Group 2: Baseline, C2 D1, C4/5 D1. In tumour at baseline, C4 D14-21 (group 1a only) & immediately after surgery(group 1 only)
Determine the statistical association of FRET efficiency (at baseline and any subsequent changes) determined by measuring tumoural HER2-HER3 dimer expression with radiological and pathological responses to systemic treatment.
Measured: Each cycle (C) is 21 days (D). HER2-HER3 dimer measured in tumour at baseline, C4 D14-21 (group 1a only) & immediately after surgery (group 1 only). Radiology imaging as standard of care (SoC) during course of the study.
Determine the statistical association of FRET efficiency (at baseline and any subsequent changes) determined by measuring exosomal HER2-HER3 dimer expression with radiological and pathological responses to systemic treatment
Measured: Each cycle (C) is 21 days (D). In group1a: Baseline, C2 D1, C5 D1, C6 D1 and C8 D21-42. In Group 1b: Baseline, C2 D1, C6 D21-42, Group 2: Baseline, C2 D1, C4/5 D1. Pathological response immediately after surgery(group 1 only). Radiology imaging as SoC
Determine the statistical association of the levels of expression of immune cell markers (at baseline and any subsequent changes) with radiological and pathological responses to systemic treatment. (OPTIONAL CONSENT-Guy's hospital site only).
Measured: Each cycle (C) is 21 days (D). In group1a: Baseline, C2 D1, C5 D1, C6 D1 and C8 D21-42. In Group 1b: Baseline, C2 D1, C6 D21-42, Group 2: Baseline, C2 D1, C4/5 D1. Pathological response immediately after surgery(group 1 only). Radiology imaging as SoC.
Determine feasibility of using exosomal expression testing in a National Health Service (NHS) practice.
- Determine the percentage of participant derived blood samples processed appropriately in the clinical setting and transported to the central laboratory for exosome analysis.
- Describe the reasons for obtaining unsuitable participant derived blood samples from clinics.
- Determine the percentage of participant derived blood samples that are successfully analysed for biomarker expression i.e. % of blood samples demonstrating exosomal isolation, % of blood samples demonstrating HER2-HER3 dimerisation.
Measured: On study completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2020
- Study start20 Dec 2019
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
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.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Brighton and Sussex University Hospitals NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04288141
- Sponsor's protocol ID
- HERdi PREDICT
- Acronym
- HERdi PREDICT
- Status last verified
- Nov 2022
- First submitted
- 14 Feb 2020
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HERdi PREDICT: A Pilot Study to Measure the Expression of the HER2-HER3 Dimer in Samples From Patients With HER2 Positive Breast Cancer Receiving HER2 Targeted Therapies
- ClinicalTrials.gov ID
- NCT04288141
- Acronym / sponsor ID
- HERdi PREDICT / HERdi PREDICT
- Conditions
- HER2-positive Breast Cancer
- Keywords
- FLIM-FRET, HER2-HER3 dimer, Exosomes, Predictive biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Brighton and Sussex University Hospitals NHS Trust
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 28 Feb 2020 (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 treatment of breast cancer is determined by its 'receptor (or signal) status'. Receptors are signals present on all cells and if abnormal can drive cancer growth. One of the signals that can drive breast cancer growth is the HER2 receptor/signal. One quarter of all breast cancers are found to have too many HER2 signals i.e. HER2-positive breast cancer.
HER2 is a member of the HER-family which constitutes HER1,HER2,HER3,and HER4 signals. Currently, tests can identify breast cancers with too much HER2, from a biopsy, so a cancer doctor can prescribe anti-HER2 treatment to block these signals. These drugs have improved survival rates in HER2-positive breast cancer. Members of the HER family can also 'pair' with each other to activate signals that encourage cancer growth. For example, HER3 naturally 'pairs' with HER2. Though anti-cancer drugs have been developed to target this pairing, the current method of patient selection is not developed to detect pairing of signals in tissue biopsies. A specialist imaging technique called FLIM-FRET (FLIM- Fluorescence Lifetime Imaging Microscopy; FRET- Forster resonance energy transfer) can identify signal pairing on cancer cells from tissue, and potentially, from blood samples.
This study involves having blood tests while participants receive anti-HER2 treatment. The investigators will also seek permission to take samples of cancer tissue from the biopsies that were already carried out, e.g. at diagnosis. Some participants may need an additional biopsy, which will be discussed with participants prior to consent. This study will use the specialist FLIM-FRET technique to measure the signal pairing in tumour samples and blood samples. Investigators will measure if the levels of signal pairing from blood are the same as that from tissue, which could lead to bloods tests being used to select patients for anti-HER2 treatments, instead of invasive tissue biopsies. Changes in signal pairing may also help to predict if a cancer is becoming resistant to treatment.
Detailed description
The study will recruit 40 participants to two groups as outlined below:
Group 1: Early HER2 positive breast cancer (20 patients) Group 2: Metastatic HER2 positive breast cancer (20 patients)
The two groups represent the natural spectrum of breast cancer in its clinical presentation.
GROUP 1: EARLY BREAST CANCER
Group 1 will include patients with early HER2 positive breast cancer recommended to receive neo-adjuvant chemotherapy inclusive of HER2 directed therapy (trastuzumab + pertuzumab), prior to proceeding to curative surgery. All participants are expected to have had a diagnostic core biopsy and definitive breast surgery on completion of neoadjuvant chemotherapy as standard of care. Blood samples will be obtained for biomarker analysis in exosomes. Participants in Group 1 A will be requested to have a biopsy on completion of anthracycline based chemotherapy and prior to commencing on HER2-directed therapy.
Group 1 A: Participants in Group 1 commencing treatment with anthracycline based chemotherapy for up to 4 cycles followed by a switch in treatment to taxane based chemotherapy in combination with HER2 directed therapy (trastuzumab + pertuzumab) for up to 4 cycles
Group 1 B: Participants in Group 1 commencing treatment with taxane based systemic therapy in combination with HER2 directed therapy (trastuzumab + pertuzumab) for up to 6 cycles:
GROUP 2: METASTATIC BREAST CANCER:
Group 2 will include patients will include participants recommended commencing any line of palliative systemic therapy inclusive of a HER2 directed therapy by their treating oncologist. All participants are expected to have had a diagnostic core biopsy. Blood samples will be obtained for biomarker analysis in exosomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Early HER2 positive breast cancer | – | Other: Acquisition of blood samples and tumour tissue samples (biopsies)Study participants in Group 1 will include patients prescribed neoadjuvant systemic therapy (including trastuzumab and pertuzumab) by their treating oncologist for a diagnosis of HER2 positive early breast cancer. |
| Group 2: Metastatic HER2 positive breast cancer | – | Other: Acquisition of blood samples and tumour tissue samples (biopsies)Study participants in Group 2 will include patients prescribed systemic therapy (including trastuzumab and pertuzumab) by their treating oncologist for a diagnosis of HER2 positive metastatic breast cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1: Early HER2 positive breast cancer and prescribed neoadjuvant chemotherapy including trastuzumab and pertuzumab as per physician discretion. Group 2: Metastatic HER2 positive breast cancer and prescribed chemotherapy including trastuzumab and pertuzumab as per physician discretion.
Key inclusion criteria (12 listed)
- Female or Male aged 18 years or above.
- Histologically documented breast cancer. In participants with metastatic breast cancer (Group 2), the biopsy should have been obtained following or at the time of diagnosis of metastatic breast cancer. (refer to inclusion criteria 10 for group 2 specific criteria)
- HER2 positive breast cancer, to be established by immunohistochemistry and confirmed by fluorescence in situ hybridisation or dual in situ hybridisation in borderline cases as per standard of care guidelines.
- Confirmation of availability of sufficient tumour tissue (from diagnostic core biopsy) for biomarker analysis (Refer to study laboratory manual)
- Fit for treatment with chemotherapy in combination with HER2 targeted therapy as per investigator discretion
Key exclusion criteria (4 listed)
- Significant thrombocytopaenia or abnormal clotting screen or any other condition that would contraindicate a tissue biopsy if this were required, in the investigator's opinion.
- Participant unwilling to undergo study required tissue biopsies and blood sampling.
- Any other significant underlying condition or comorbidity which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study or the participant's ability to participate in the study.
- Inability of participant to co-operate with study procedures as judged by the investigator.
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 |
|---|---|---|
| Acquisition of blood samples and tumour tissue samples (biopsies)Acquisition of blood samples and tumour tissue samples (biopsies) in a sequential manner as participants proceed through HER2-directed therapy as prescribed by their oncologist. | Other | Group 1: Early HER2 positive breast cancer, Group 2: Metastatic HER2 positive breast cancer |
Primary outcome
Compare HER2-HER3 dimer expression as detected by FLIM-FRET (% positive for HER2-HER3 dimer expression with FRET efficiency ≥8.56%) to HER2 over-expression (% positive for HER2 over-expression by IHC ± FISH) in patient-derived tumour samples.
Time frame: Group 1: Baseline biopsy and definitive surgical specimen. Group 2: Baseline biopsy.
9 secondary outcomes
Describe the range of FRET efficiency determined by measuring tumoural HER2-HER3 dimerisation as a continuous variable.
Time frame: Group 1: Baseline biopsy and definitive surgical specimen. Group 2: Baseline biopsy.
Compare the HER2-HER3 dimer expression level in tumour samples to matched blood samples (exosomal expression) as detected by FLIM-FRET.
Time frame: Each cycle (C) is 21 days (D). Group 1A & Group 1B: Baseline biopsy,definitive surgical specimen and paired blood samples. Group 1A: Also in matched interim tumour and blood sample (C4 D14-21). Group 2: Baseline biopsy and blood sample
Compare HER2 expression in blood samples (exosomes) by protein detection assays e.g. dot blots to HER2 status in matched tumour tissue as determined by IHC ± FISH.
Time frame: Each cycle (C) is 21 days (D). In group1 HER2 expression in matched participant tumour tissue and blood will be compared at baseline and immediately after completion of neoadjuvant therapy/surgery. In Group 2, to be assessed at baseline only.
Determine the range of measurable exosomal FRET efficiency determined by measuring exosomal HER2-HER3 dimer expression.
Time frame: Each cycle (C) is 21 days (D). In group1a: Baseline, C2 D1, C5 D1, C6 D1 and C8 D21-42. In Group 1b: Baseline, C2 D1, C6 D21-42, Group 2: Baseline, C2 D1, C4/5 D1.
Determine if patient derived tumour and blood samples (exosomes) demonstrate a change in HER2-HER3 dimer expression in response to systemic HER2-directed therapy (% positive for change in HER2-HER3 dimer expression).
Time frame: Each cycle (C) is 21 days (D). In group1a: Baseline, C2 D1, C5 D1, C6 D1 and C8 D21-42. In Group 1b: Baseline, C2 D1, C6 D21-42, Group 2: Baseline, C2 D1, C4/5 D1. In tumour at baseline, C4 D14-21 (group 1a only) & immediately after surgery(group 1 only)
Determine the statistical association of FRET efficiency (at baseline and any subsequent changes) determined by measuring tumoural HER2-HER3 dimer expression with radiological and pathological responses to systemic treatment.
Time frame: Each cycle (C) is 21 days (D). HER2-HER3 dimer measured in tumour at baseline, C4 D14-21 (group 1a only) & immediately after surgery (group 1 only). Radiology imaging as standard of care (SoC) during course of the study.
Determine the statistical association of FRET efficiency (at baseline and any subsequent changes) determined by measuring exosomal HER2-HER3 dimer expression with radiological and pathological responses to systemic treatment
Time frame: Each cycle (C) is 21 days (D). In group1a: Baseline, C2 D1, C5 D1, C6 D1 and C8 D21-42. In Group 1b: Baseline, C2 D1, C6 D21-42, Group 2: Baseline, C2 D1, C4/5 D1. Pathological response immediately after surgery(group 1 only). Radiology imaging as SoC
Determine the statistical association of the levels of expression of immune cell markers (at baseline and any subsequent changes) with radiological and pathological responses to systemic treatment. (OPTIONAL CONSENT-Guy's hospital site only).
Time frame: Each cycle (C) is 21 days (D). In group1a: Baseline, C2 D1, C5 D1, C6 D1 and C8 D21-42. In Group 1b: Baseline, C2 D1, C6 D21-42, Group 2: Baseline, C2 D1, C4/5 D1. Pathological response immediately after surgery(group 1 only). Radiology imaging as SoC.
Determine feasibility of using exosomal expression testing in a National Health Service (NHS) practice.
Time frame: On study completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HER2-positive Breast Cancer, run by King's College London at 2 sites in United Kingdom.
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 12 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Louisa McDonald (0207 188 2007, Louisa.McDonald@gstt.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare HER2-HER3 dimer expression as detected by FLIM-FRET (% positive for HER2-HER3 dimer expression with FRET efficiency ≥8.56%) to HER2 over-expression (% positive for HER2 over-expression by IHC ± FISH) in patient-derived tumour samples. (time frame: Group 1: Baseline biopsy and definitive surgical specimen. Group 2: Baseline biopsy.). 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 14 Nov 2022.