The UK Plasma Based Molecular Profiling of Advanced Breast Cancer to Inform Therapeutic CHoices (plasmaMATCH) Trial (plasmaMATCH)
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|ClinicalTrials.gov Identifier: NCT03182634|
Recruitment Status : Recruiting
First Posted : June 9, 2017
Last Update Posted : January 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Advanced Breast Cancer||Drug: Fulvestrant Drug: Neratinib Drug: AZD5363 Drug: Olaparib Drug: AZD6738||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||December 15, 2016|
|Estimated Primary Completion Date :||November 2022|
|Estimated Study Completion Date :||November 2023|
Experimental: Cohort A - Extended-dose fulvestrant
Fulvestrant 500mg IM on Cycle 1 Days 1, 8 and 15 and Cycle 2 onwards Days 1 and 15
Experimental: Cohort B - Neratinib
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
Experimental: Cohort C - AZD5363 and fulvestrant
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
Experimental: Cohort D - AZD5363
AZD5363 480mg PO BID on a 7 day schedule of 4 days on treatment followed by 3 days off treatment
Experimental: Cohort E - olaparib and AZD6738
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.
- 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 ]
- Clinical benefit rate [ Time Frame: up to 24 weeks ]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.
- Progression free survival [ Time Frame: up to 24 weeks ]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.
- Incidence of treatment-emergent adverse events (safety and tolerability) [ Time Frame: through study completion, estimated average 1 year ]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
- Duration of response for each cohort [ Time Frame: through study completion, estimated average 1 year ]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.
- Frequency of mutations identified in ctDNA screening [ Time Frame: Baseline ]The proportion of patients undergoing ctDNA screening who have each targetable mutation of interest will be presented.
- The proportion of patients with a targetable mutation who enter a therapeutic component [ Time Frame: Baseline ]The proportion of patients with a targetable mutation who enter the relevant therapeutic cohort will also be presented.
- Agreement between ctDNA mutation status and tissue mutation status for patients entering the therapeutic component [ Time Frame: Baseline ]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.
- Maximum Plasma Concentration (Cmax) [ Time Frame: Monthly up to 4 months ]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.
- Area Under the Curve (AUC) [ Time Frame: Monthly up to 4 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03182634
|Contact: plasmaMATCH Trial Managerfirstname.lastname@example.org|
|Royal Marsden Hosital||Recruiting|
|Sutton, England, United Kingdom, SM2 5PT|
|Royal Bournemouth Hospital||Recruiting|
|Bournemouth, United Kingdom|
|Bristol Haematology and Oncology Centre||Recruiting|
|Bristol, United Kingdom|
|Cambridge, United Kingdom|
|Velindre Cancer Centre||Recruiting|
|Cardiff, United Kingdom|
|Western General Hospital||Recruiting|
|Edinburgh, United Kingdom|
|Royal Devon and Exeter Hospital||Recruiting|
|Exeter, United Kingdom|
|Beatson West of Scotland Cancer Centre||Recruiting|
|Glasgow, United Kingdom|
|Clatterbridge Cancer Centre||Recruiting|
|Liverpool, United Kingdom|
|Barts Health Trust||Recruiting|
|London, United Kingdom|
|Royal Marsden Hospital||Recruiting|
|London, United Kingdom|
|University College Hospital London||Recruiting|
|London, United Kingdom|
|Kent Oncology Centre||Recruiting|
|Maidstone, United Kingdom|
|Manchester, United Kingdom|
|Oxford, United Kingdom|
|Plymouth, United Kingdom|
|Weston Park Hospital||Recruiting|
|Sheffield, United Kingdom|
|University Hospitals Southampton NHS Foundation Trust||Recruiting|
|Southampton, United Kingdom|
|Royal Cornwall Hospital||Recruiting|
|Truro, United Kingdom|