LUCY
Research type
Research Study
Full title
LUCY - Lynparza Breast Cancer Real World Utility, Clinical Effectiveness and Safety Study A Phase IIIb, Single-arm, Open-label Multicentre Study of Olaparib Monotherapy in the Treatment of HER2-ve Metastatic Breast Cancer Patients with Germline BRCA1/2 Mutations
IRAS ID
231946
Contact name
Charlotte Pai
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2017-001054-34
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 8 months, 12 days
Research summary
Research Summary
This is an open-label study of olaparib monotherapy in the treatment of HER2-ve metastatic breast cancer patients with germline BRCA1/2 mutations (gBRCA1/2).
It is the current practice to use monotherapy cytotoxic agents, but there is no evidence to support one over another, and all are associated with only moderate outcomes. This has led to a wide variation in standard of care treatments used across different regions and countries. This can lead to uncertainty in terms of the prognostic outlook for patients.
Currently there is limited data to help support the use of olaparib monotherapy treatment for patients with metastatic breast cancer associated with gBRCA1/2 mutations.
The results from three phase II studies have demonstrated the potential benefit of olaparib as monotherapy treatment in breast cancer patients with g BRCA1/2 mutations. Olaparib has been well tolerated across various cancer entities.
The aim of this study is to evaluate the clinical response to olaparib monotherapy in a real-world setting, as assessed by the prescribing Investigator, in patients with proven gBRCA mutations. This study will generate additional, phase IIIb data to support other olaparib studies, which may help inform and guide clinical practice.
The proposed study will be limited to patients with metastatic breast cancer associated with gBRCA1/2 mutations, for whom clinical activity can be expected based on the results of phase II studies in this population. Therefore, a positive benefit/risk profile is expected and no ethical issues are identified from exposing patients to olaparib within the planned clinical study.
Participants will take daily dose of 300 mg of olaparib orally in tablet form.
The study is being sponsored by Astra Zeneca AB. The study will be conducted globally in 17 countries, with approximately 2500 patients being screened at approximately 180 sites in order to recruit approximately 250 participants.Summary of Results
This study was conducted in the real-world setting, meaning the data was generated during routine clinical practice.
Based on Investigator tumour assessment in 255 breast cancer patients, treatment with Olaparib showed a median progression free survival (the time between treatment aimed at shrinking or controlling cancer, and signs that it has started to grow again in half the patients) of 8.18 months:
• The estimated progression free survival rate at 24 months was 18.6%.
• The estimated progression free survival rate at 30 months was 15.0%.In this study, the median overall survival (the time from treatment to the point at which half of the patients are living) was 24.94 months.
The study showed no difference in the survival rate of patients based on the number of previous treatments and hormone receptor status [oestrogen receptor/progesterone receptor].
Safety data for olaparib was consistent with known safety information observed in previous studies.
REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/2024
Date of REC Opinion
14 Feb 2018
REC opinion
Further Information Favourable Opinion