Advanced Breast CancerPhase 2plasmaMATCHNCT03182634
The UK Plasma Based Molecular Profiling of Advanced Breast Cancer to Inform Therapeutic CHoices (plasmaMATCH) Trial
A Phase 2 study testing Fulvestrant, Neratinib and AZD5363 in people with Advanced Breast Cancer, run by Institute of Cancer Research, United Kingdom at 19 sites in United Kingdom.
Trial summary
plasmaMATCH is a multi-centre phase IIa umbrella trial platform consisting of a ctDNA screening component and a therapeutic component. plasmaMATCH aims to assess whether ctDNA screening can be used to detect patient subgroups who will be sensitive to targeted therapies, and will also assess the safety and activity of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Fulvestrant, Neratinib and AZD5363
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,150 participants
- Where
- 19 sitesUnited Kingdom
- Study dates
- 15 Dec 2016to Nov 2023
- Phase
- Phase 2
- 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
- Female.
- Aged ≥ 18 years old.
- Histologically confirmed invasive breast carcinoma.
- Metastatic or recurrent locally advanced breast cancer that is not suitable for treatment with radical or curative intent.
- Demonstrated progression of disease by radiological assessment or by clinical assessment within the last 6 weeks.
- Measurable disease by RECIST v1.1.
Show all 16Show fewer
- Patients must have completed at least one prior line of treatment for advanced breast cancer and/or relapse within 12 months of completing (neo)adjuvant chemotherapy. Patients with HER2 positive breast cancer must have been treated with at least two courses of HER2 targeted therapy in the advanced setting (or one course if no further courses of HER2 targeted therapy are available locally).
- Patient must either be suitable for a baseline biopsy of recurrent disease or have an archival biopsy of recurrent disease available. Patients are requested to consent to a baseline biopsy but if deemed unsafe by the Investigator, an archival biopsy of recurrent disease can be used instead. If it is deemed unsafe to proceed with baseline biopsy, and no archival recurrent disease biopsy is available, the patient will not be eligible for entry into the treatment cohort.
- ECOG performance status ≤ 2.
- Life expectancy >3 months in Cohorts A-D, >16 weeks in Cohort E.
- Patients must be a) surgically sterile; b) have a sterilised sole partner; c) be postmenopausal; d) must agree to practice true abstinence; or e) must agree to use effective contraception during the period of trial treatment and be willing to do so for 6 months following the end of trial treatment. Effective contraception is defined as double barrier contraception (e.g. condom plus spermicide in combination with a diaphragm, cervical cap or intrauterine device). Ovarian suppression with an LHRH agonist is not a method of contraception.
- Patients of childbearing potential should have a negative serum pregnancy test within 14 days prior to initiation of trial treatment.
- At least 4 weeks washout period after the end of trial treatment on a different cohort within plasmaMATCH.
- Adequate haematological, renal and hepatic function as defined by cohort-specific criteria in protocol.
- For patients with ER positive breast cancer in Cohorts A, B and C: EITHER postmenopausal, as defined by at least one of the following criteria: Age >60 years; Age <60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females; Documented bilateral oophorectomy; medically confirmed ovarian failure. OR Pre-/peri-menopausal (i.e. not meeting the criteria for being postmenopausal) if being treated with an LHRH agonist that was commenced at least 4 weeks prior to Cycle 1 Day 1, and continues on the LHRH agonist throughout the trial period.
- NB. Additional eligibility criteria apply for entry into each treatment cohort.
Who cannot join
- Prior treatment with radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy, chemotherapy or IMPs during the previous 4 weeks (6 weeks for nitrosoureas, Mitomycin-C) before trial treatment, except for hormonal therapy with LHRH analogues, which are permitted, and bisphosphonates or RANK ligand antibodies that are permitted for the management of bone metastases.
- Uncontrolled CNS disease (brain metastases or leptomeningeal disease). Patients with prior diagnosis of CNS metastases must be stable by clinical assessment having ceased steroids after prior treatment.
- History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction within the last 6 months or ventricular arrhythmia. Patients with a history of any of the above listed cardiac conditions judged not to be clinically significant by the local investigator must be notified to the trial team at the ICR-CTSU for approval by the CI and/or Cohort Lead.
- Ongoing toxic manifestations of previous treatments Grade ≥1. Exceptions to this are alopecia or toxicities which in the opinion of the Investigator should not exclude the patient. Such cases should be clearly documented in the patient's notes by the Investigator.
- Major surgery (excluding minor procedures, e.g. placement of vascular access) within 4 weeks of the first dose of trial treatment.
- Pregnant or breastfeeding.
Show all 9Show fewer
- Any condition that according to the treating physician may compromise the patient's safety or the conduct of the trial.
- Current malignancies of other types, with the exception of adequately treated in situ carcinoma of the cervix and basal or squamous cell carcinoma of the skin. Cancer survivors, who have undergone potentially curative therapy for a prior malignancy and have no evidence of the disease for 3 years or more are eligible for the trial.
- NB. Additional eligibility criteria apply for entry into each treatment cohort.
Trial locations and contacts
19 sites in 1 country.
plasmaMATCH Trial Manager contact
19 sites in 1 country
United Kingdom19 sites, 19 recruiting
- Recruiting
Royal Bournemouth Hospital
Bournemouth
- Recruiting
Bristol Haematology and Oncology Centre
Bristol
- Recruiting
Addenbrooke's Hospital
Cambridge
- Recruiting
Velindre Cancer Centre
Cardiff
- Recruiting
Western General Hospital
Edinburgh
- Recruiting
Royal Devon and Exeter Hospital
Exeter
- Recruiting
Beatson West of Scotland Cancer Centre
Glasgow
- Recruiting
Clatterbridge Cancer Centre
Liverpool
- Recruiting
Barts Health Trust
London
- Recruiting
Royal Marsden Hospital
London
- Recruiting
University College Hospital London
London
- Recruiting
Kent Oncology Centre
Maidstone
- Recruiting
Christie Hospital
Manchester
- Recruiting
Churchill Hospital
Oxford
- Recruiting
Derriford Hospital
Plymouth
- Recruiting
Weston Park Hospital
Sheffield
- Recruiting
University Hospitals Southampton NHS Foundation Trust
Southampton
- Recruiting
Royal Marsden Hosital
Sutton, England, SM2 5PT
- Recruiting
Royal Cornwall Hospital
Truro
About this study
Official title: A Multiple Parallel Cohort, Multi-centre Phase IIa Trial Aiming to Provide Proof of Principle Efficacy for Designated Targeted Therapies in Patients With Advanced Breast Cancer Where the Targetable Mutation is Identified Through ctDNA
plasmaMATCH is a multi-centre phase IIa umbrella trial platform consisting of a ctDNA screening component and a therapeutic component. plasmaMATCH aims to assess whether ctDNA screening can be used to detect patient subgroups who will be sensitive to targeted therapies, and will also assess the safety and activity of the targeted treatments.
- Conditions
- Advanced Breast Cancer
- Being tested
- Fulvestrant, Neratinib, AZD5363, Olaparib, AZD6738
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FulvestrantDrug
NeratinibDrug
AZD5363Drug
OlaparibDrug
AZD6738Drug
| Study group | Role | What they receive |
|---|---|---|
| Cohort A - Extended-dose fulvestrant | Experimental | Fulvestrant 500mg IM on Cycle 1 Days 1, 8 and 15 and Cycle 2 onwards Days 1 and 15 Receives: Drug: Fulvestrant |
| Cohort B - Neratinib | Experimental | Neratinib 240mg PO on a continuous schedule starting on Cycle 1 Day 1 AND in ER positive breast cancer, fulvestrant 500mg IM on Cycle 1 Days 1 and 15 and Cycle 2 onwards Day 1 Receives: Drug: Fulvestrant; Drug: Neratinib |
| Cohort C - AZD5363 and fulvestrant | Experimental | AZD5363 400mg PO BID on a 7 day schedule of 4 days on treatment followed by 3 days off treatment AND fulvestrant 500mg IM Cycle 1 Days 1 and 15 and Cycle 2 onwards Day 1 Receives: Drug: Fulvestrant; Drug: AZD5363 |
| Cohort D - AZD5363 | Experimental | AZD5363 480mg PO BID on a 7 day schedule of 4 days on treatment followed by 3 days off treatment Receives: Drug: AZD5363 |
| Cohort E - olaparib and AZD6738 | Experimental | AZD6738 160mg to be administered once daily on Days 1-7 of each cycle and olaparib 300mg to be administered twice daily on a continuous schedule starting on Cycle 1 Day 1. Receives: Drug: Olaparib; Drug: AZD6738 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint for Cohorts A to E is confirmed objective response rate as defined by RECIST v1.1 for each cohort separately
Measured: up to 24 weeks
Secondary outcomes (9)
Clinical benefit rate
A patient will be defined as having clinical benefit if they have either a complete/partial response or stable disease as defined by RECIST v1.1 lasting at least 24 weeks.
Measured: up to 24 weeks
Progression free survival
PFS will be measured from the date of entry into the treatment cohort until first date of either confirmed progressive disease according to RECIST criteria or death.
Measured: up to 24 weeks
Incidence of treatment-emergent adverse events (safety and tolerability)
Incidence of treatment-emergent adverse events (safety and tolerability) will be assessed throughout the treatment period using the NCI CTCAE v4.0 and summarised in tabular format. Reported toxicities will be coded using MedDRA (current version). For each agent,the proportion of patients reporting a dose reduction/delay during trial treatment will be presented
Measured: through study completion, estimated average 1 year
Duration of response for each cohort
The duration of response is measured from the time of first documentation of RECIST complete/partial response (whichever status is recorded first) until the first date that recurrence or progressive disease is objectively documented, taking as reference for progressive disease the smallest measurements recorded since the treatment started. Median duration of response and interquartile range will be presented along with its 95% confidence interval.
Measured: through study completion, estimated average 1 year
Frequency of mutations identified in ctDNA screening
The proportion of patients undergoing ctDNA screening who have each targetable mutation of interest will be presented.
Measured: Baseline
The proportion of patients with a targetable mutation who enter a therapeutic component
The proportion of patients with a targetable mutation who enter the relevant therapeutic cohort will also be presented.
Measured: Baseline
Agreement between ctDNA mutation status and tissue mutation status for patients entering the therapeutic component
The proportion of cancers with a ctDNA detected mutation that have a matching mutation on subsequent tissue biopsy will be presented with associated exact two-sided 95% confidence interval.
Measured: Baseline
Maximum Plasma Concentration (Cmax)
Changes in Maximum Plasma Concentration during the treatment period for Cohorts A and B will be displayed graphically per patient. Values at specific time points will be summarised across all patients using the mean, standard deviation and range. Analyses will be performed separately for patients in Cohorts A and B.
Measured: Monthly up to 4 months
Area Under the Curve (AUC)
Changes in area under the plasma concentration vs time curve during the treatment period for Cohorts A and B will be displayed graphically per patient. Values at specific time points will be summarised across all patients using the mean, standard deviation and range. Analyses will be performed separately for patients in Cohorts A and B.
Measured: Monthly up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start15 Dec 2016
- Primary completionNov 2022 (estimated)
- Study completionNov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182634
- Sponsor's protocol ID
- ICR-CTSU/2015/10056
- Acronym
- plasmaMATCH
- Status last verified
- Jan 2019
- First submitted
- 10 Jan 2017
- Last updated
- 22 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mayerhoefer ME, Kienzle A, Woo S, Vargas HA. Update on Liquid Biopsy. Radiology. 2025 Jun;315(3):e241030. doi: 10.1148/radiol.241030.
PubMed 40525978Kingston B, Cutts RJ, Bye H, Beaney M, Walsh-Crestani G, Hrebien S, Swift C, Kilburn LS, Kernaghan S, Moretti L, Wilkinson K, Wardley AM, Macpherson IR, Baird RD, Roylance R, Reis-Filho JS, Hubank M, Faull I, Banks KC, Lanman RB, Garcia-Murillas I, Bliss JM, Ring A, Turner NC. Genomic profile of advanced breast cancer in circulating tumour DNA. Nat Commun. 2021 Apr 23;12(1):2423. doi: 10.1038/s41467-021-22605-2.
PubMed 33893289Turner NC, Kingston B, Kilburn LS, Kernaghan S, Wardley AM, Macpherson IR, Baird RD, Roylance R, Stephens P, Oikonomidou O, Braybrooke JP, Tuthill M, Abraham J, Winter MC, Bye H, Hubank M, Gevensleben H, Cutts R, Snowdon C, Rea D, Cameron D, Shaaban A, Randle K, Martin S, Wilkinson K, Moretti L, Bliss JM, Ring A. Circulating tumour DNA analysis to direct therapy in advanced breast cancer (plasmaMATCH): a multicentre, multicohort, phase 2a, platform trial. Lancet Oncol. 2020 Oct;21(10):1296-1308. doi: 10.1016/S1470-2045(20)30444-7. Epub 2020 Sep 10.
PubMed 32919527
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Parallel Cohort, Multi-centre Phase IIa Trial Aiming to Provide Proof of Principle Efficacy for Designated Targeted Therapies in Patients With Advanced Breast Cancer Where the Targetable Mutation is Identified Through ctDNA
- ClinicalTrials.gov ID
- NCT03182634
- Acronym / sponsor ID
- plasmaMATCH / ICR-CTSU/2015/10056
- Conditions
- Advanced Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,150 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Collaborators
- Royal Marsden NHS Foundation Trust
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Nov 2023 (estimated)
- First posted
- 9 Jun 2017 (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.
plasmaMATCH is a multi-centre phase IIa umbrella trial platform consisting of a ctDNA screening component and a therapeutic component. plasmaMATCH aims to assess whether ctDNA screening can be used to detect patient subgroups who will be sensitive to targeted therapies, and will also assess the safety and activity of the targeted treatments.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Cohort A - Extended-dose fulvestrant | Experimental | Drug: FulvestrantFulvestrant 500mg IM on Cycle 1 Days 1, 8 and 15 and Cycle 2 onwards Days 1 and 15 |
| Cohort B - Neratinib | Experimental | Drug: Fulvestrant, Drug: NeratinibNeratinib 240mg PO on a continuous schedule starting on Cycle 1 Day 1 AND in ER positive breast cancer, fulvestrant 500mg IM on Cycle 1 Days 1 and 15 and Cycle 2 onwards Day 1 |
| Cohort C - AZD5363 and fulvestrant | Experimental | Drug: Fulvestrant, Drug: AZD5363AZD5363 400mg PO BID on a 7 day schedule of 4 days on treatment followed by 3 days off treatment AND fulvestrant 500mg IM Cycle 1 Days 1 and 15 and Cycle 2 onwards Day 1 |
| Cohort D - AZD5363 | Experimental | Drug: AZD5363AZD5363 480mg PO BID on a 7 day schedule of 4 days on treatment followed by 3 days off treatment |
| Cohort E - olaparib and AZD6738 | Experimental | Drug: Olaparib, Drug: AZD6738AZD6738 160mg to be administered once daily on Days 1-7 of each cycle and olaparib 300mg to be administered twice daily on a continuous schedule starting on Cycle 1 Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Female.
- Aged ≥ 18 years old.
- Histologically confirmed invasive breast carcinoma.
- Metastatic or recurrent locally advanced breast cancer that is not suitable for treatment with radical or curative intent.
- Demonstrated progression of disease by radiological assessment or by clinical assessment within the last 6 weeks.
Key exclusion criteria (9 listed)
- Prior treatment with radiotherapy (except for palliative reasons), endocrine therapy, immunotherapy, chemotherapy or IMPs during the previous 4 weeks (6 weeks for nitrosoureas, Mitomycin-C) before trial treatment, except for hormonal therapy with LHRH analogues, which are permitted, and bisphosphonates or RANK ligand antibodies that are permitted for the management of bone metastases.
- Uncontrolled CNS disease (brain metastases or leptomeningeal disease). Patients with prior diagnosis of CNS metastases must be stable by clinical assessment having ceased steroids after prior treatment.
- History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction within the last 6 months or ventricular arrhythmia. Patients with a history of any of the above listed cardiac conditions judged not to be clinically significant by the local investigator must be notified to the trial team at the ICR-CTSU for approval by the CI and/or Cohort Lead.
- Ongoing toxic manifestations of previous treatments Grade ≥1. Exceptions to this are alopecia or toxicities which in the opinion of the Investigator should not exclude the patient. Such cases should be clearly documented in the patient's notes by the Investigator.
- Major surgery (excluding minor procedures, e.g. placement of vascular access) within 4 weeks of the first dose of trial 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 |
|---|---|---|
| Fulvestrant | Drug | Cohort A - Extended-dose fulvestrant, Cohort B - Neratinib, Cohort C - AZD5363 and fulvestrant |
| Neratinib | Drug | Cohort B - Neratinib |
| AZD5363 | Drug | Cohort C - AZD5363 and fulvestrant, Cohort D - AZD5363 |
| Olaparib | Drug | Cohort E - olaparib and AZD6738 |
| AZD6738 | Drug | Cohort E - olaparib and AZD6738 |
Primary outcome
The primary endpoint for Cohorts A to E is confirmed objective response rate as defined by RECIST v1.1 for each cohort separately
Time frame: up to 24 weeks
9 secondary outcomes
Clinical benefit rate
Time frame: up to 24 weeks
Progression free survival
Time frame: up to 24 weeks
Incidence of treatment-emergent adverse events (safety and tolerability)
Time frame: through study completion, estimated average 1 year
Duration of response for each cohort
Time frame: through study completion, estimated average 1 year
Frequency of mutations identified in ctDNA screening
Time frame: Baseline
The proportion of patients with a targetable mutation who enter a therapeutic component
Time frame: Baseline
Agreement between ctDNA mutation status and tissue mutation status for patients entering the therapeutic component
Time frame: Baseline
Maximum Plasma Concentration (Cmax)
Time frame: Monthly up to 4 months
Area Under the Curve (AUC)
Time frame: Monthly up to 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2019.
- Derived from this study: PubMed 40525978Mayerhoefer ME, Kienzle A, Woo S, Vargas HA. Update on Liquid Biopsy. Radiology. 2025 Jun;315(3):e241030. doi: 10.1148/radiol.241030.
- Derived from this study: PubMed 33893289Kingston B, Cutts RJ, Bye H, Beaney M, Walsh-Crestani G, Hrebien S, Swift C, Kilburn LS, Kernaghan S, Moretti L, Wilkinson K, Wardley AM, Macpherson IR, Baird RD, Roylance R, Reis-Filho JS, Hubank M, Faull I, Banks KC, Lanman RB, Garcia-Murillas I, Bliss JM, Ring A, Turner NC. Genomic profile of advanced breast cancer in circulating tumour DNA. Nat Commun. 2021 Apr 23;12(1):2423. doi: 10.1038/s41467-021-22605-2.
- Derived from this study: PubMed 32919527Turner NC, Kingston B, Kilburn LS, Kernaghan S, Wardley AM, Macpherson IR, Baird RD, Roylance R, Stephens P, Oikonomidou O, Braybrooke JP, Tuthill M, Abraham J, Winter MC, Bye H, Hubank M, Gevensleben H, Cutts R, Snowdon C, Rea D, Cameron D, Shaaban A, Randle K, Martin S, Wilkinson K, Moretti L, Bliss JM, Ring A. Circulating tumour DNA analysis to direct therapy in advanced breast cancer (plasmaMATCH): a multicentre, multicohort, phase 2a, platform trial. Lancet Oncol. 2020 Oct;21(10):1296-1308. doi: 10.1016/S1470-2045(20)30444-7. Epub 2020 Sep 10.
Related trials for Advanced Breast Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
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.
plasmaMATCH Trial Manager contact
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fulvestrant, Neratinib and AZD5363 in people with Advanced Breast Cancer, run by Institute of Cancer Research, United Kingdom at 19 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 16 inclusion and 9 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 22 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 plasmaMATCH Trial Manager (plasmamatch-icrctsu@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint for Cohorts A to E is confirmed objective response rate as defined by RECIST v1.1 for each cohort separately (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03182634, which also lists 3 linked publications.
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 22 Jan 2019.