The UK Plasma Based Molecular Profiling of Advanced Breast Cancer to Inform Therapeutic CHoices (plasmaMATCH) Trial

Sponsor
Institute of Cancer Research, United Kingdom
Study ID
NCT03182634
Phase
PHASE2
Status
Unknown

Conditions

  • Advanced Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fulvestrant — DRUG
  • Neratinib — DRUG
  • AZD5363 — DRUG
  • Olaparib — DRUG
  • AZD6738 — DRUG

Study Details

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.

Key Dates

Start date
Dec 15, 2016
Status verified
Jan 2019
Primary completion
Nov 30, 2022
Completion
Nov 30, 2023

Study Design

Enrollment
1,150 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • 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.

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 ]

Central Contacts

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