VIOLETTE

• Research type

  Research Study

• Full title

  A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination with Olaparib versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant Repair (HRR)-related Genes (including BRCA1/2)

• IRAS ID

  233555

• Contact name

  Andrew Tutt

• Contact email

  andrew.tutt@nhs.net

• Sponsor organisation

  AstraZeneca AB

• Eudract number

  2017-002361-22

• Clinicaltrials.gov Identifier

  NCT03330847

• Clinicaltrials.gov Identifier

  Not applicable, Not applicable

• Duration of Study in the UK

  3 years, 1 months, 0 days

• Research summary

  The study is being carried out to investigate whether olaparib on its own or olaparib with one of two novel drugs (AZ6738 and AZ1775) is effective in treating different groups of breast cancer patients. Drugs such as olaparib, AZD1775 and AZD6738, target key proteins involved in the repair of DNA damage, and can kill cancer cells. The Homologous Recombination Repair [HRR] proteins are involved in the repair of DNA damage. Patients whose tumours have defects in the HRR genes may respond to a greater extent to olaparib, AZD6738 and AZD1775 treatment.

  There will be 3 groups of participants in this study:
  A. Participants with mutations in the breast cancer susceptible genes 1 and 2 (BRCA1/2)
  B. Participants with mutations in other genes involved in DNA repair (Homologous Recombination Repair [HRR] genes)
  C. Participants without any detectable HRR gene mutations

  The study is “open label,” which means that both participants and the study doctor will know which drug they are receiving.

  The study involves a:
  - Screening Period – Part 1 and Part 2
  - Treatment Period – This is for assessments done while receiving the study treatment
  - Follow Up Period – This includes the assessments done after participants have stopped treatment

  Patients who have been given the diagnosis of metastatic Triple Negative Breast Cancer and meet the inclusion criteria will be eligible for participation.

  Participants will receive study treatment until the study doctor assesses that their disease is no longer responding to treatment, but they may discontinue study participation at any time if they wish.

  There will be approximately 450 patients participating in this study at 139 centres, in 16 countries including the US and Europe.

  This study is being sponsored by a pharmaceutical company, AstraZeneca.

• REC name

  South Central - Berkshire Research Ethics Committee

• REC reference

  17/SC/0615

• Date of REC Opinion

  5 Dec 2017

• REC opinion

  Favourable Opinion