Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High ... | Recruiting
Olaparib as Adjuvant Treatment in P... | Recruiting
Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer.
OlympiA

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Medical Conditions
  • Breast Cancer
Primary Contact Details
AstraZeneca Clinical Study Information Center
1-877-240-9479
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
NCT02032823
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy
Research Details
  • Patients will be randomised in 1:1 ratio to either olaparib or placebo. Randomisation will be stratified by Hormone receptor status (ER and/or PgR positive/HER2 negative versus TNBC), prior neoadjuvant versus adjuvant chemotherapy and prior platinum use for breast cancer.

    Randomised patients will receive study treatment for up to a maximum of 12 months. All patients will have safety assessments every 2 weeks during the first month, every 4 weeks for the following 5 months and 3 monthly for the remaining 6 months of study treatment plus 30 days after its discontinuation. Following randomisation, all patients will be assessed regularly for signs, symptoms and evidence of disease recurrence by taking medical history, physical examination and mammogram/breast MRI. Efficacy assessments will be performed on a 3 monthly basis during the first 2 years, followed by 6 monthly assessments for years 3, 4 and 5 and annually thereafter. All patients (except those with bilateral mastectomy) will have mammogram / breast MRI annually for 10 years beginning 6 months after randomisation.

    All randomised patients will have clinical assessment visits for 10 years following their randomisation into the study. Once a patient completes 10 years of clinical assessment they will enter the survival follow up phase of the trial which will continue until 10 years after the last patient is randomised.
Phase
Phase 3
Study Design
Sorry, this information is not available
Study Type
Interventional
Intervention
Drug : Olaparib, Drug : Placebo

Study Arm Groups : Olaparib, Placebo

Intervention Type
See Interventions above
Primary Outcome Measures
    Invasive Disease Free Survival (IDFS); Up to 10 years
Secondary Outcome Measures
    Overall survival (OS); Until 10 years after the last patient is randomised; Distant Disease Free Survival (DDFS); Up to 10 years; Effect on the incidence of new primary contralateral breast cancers, new primary ovarian cancer, new primary fallopian tube cancer and new primary peritoneal cancer; Up to 10 years; Effect in patients identified as having a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays.; Up to LSLV & 15 years thereafter; Exposure to Olaparib (in plasma) in patients receiving Olaparib as adjuvant therapy; Visit 4, day 29; FACIT-Fatiure symptoms and EORTC QLQ-C30 Questionnaires; Up to 2 years
Publication(s)
Sorry, this information is not available
Result Reports
Check availability of results on the Clinicaltrials.gov website
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
All
Age Range
18 Years - 130 Years
Who Can Participate
Patients
Number of Participants
1500
Participant Inclusion Criteria
    Inclusion Criteria:

    - Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast that is one of the following phenotypes:

    1. Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative (not eligible for anti-HER2 therapy)

    2. ER and/or PgR positive, HER2 negative

    - Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function).

    - Completed adequate breast and axilla surgery.

    - Completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes or the combination of both. Prior platinum as potentially curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant treatment for breast cancer is allowed.

    - ECOG 0-1.

    Exclusion criteria:

    - Any previous treatment with a PARP inhibitor, including olaparib and/or known hypersensitivity to any of the excipients of study treatment.

    - Patients with second primary malignancy. EXCEPTIONS are:

    1. adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1 endometrial carcinoma

    2. other solid tumours and lymphomas (without bone marrow involvement) diagnosed ≥ 5 years prior to randomisation and treated with no evidence of disease recurrence and for whom no more than one line of chemotherapy was applied.

    - Concomitant use of known potent CYP3A inhibitors such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir

    - Evidence of metastatic breast cancer
Participant Exclusion Criteria
This is in the inclusion criteria above
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Manchester
M20 4BX
St. George's Hospital
London
England
SW17 0QT
Maidstone Hospital
Maidstone
England
ME16 9QQ
Southampton General Hospital
Southampton
England
SO16 6YD
Royal Marsden - Surrey
Sutton
England
SM2 5PT
Edinburgh Cancer Centre at Western General Hospital
Edinburgh
Scotland
EH4 2XU
London
EC1A 7BE
GSK Investigational Site
Cambridge
CB2 0QQ
St. James University Hospital, Department of Neurology
Leeds
LS9 7TF
Guy's Hospital
London
SE1 9RT
Nottingham
Nottinghamshire
NG5 1PB
Belfast
BT9 7AB
Dudley
DY1 2HQ
Birmingham
B15 2TG
Royal Free Hospital
London
NW1 2BU
Sanofi-Aventis Administrative Office
Guildford
Royal Marsden Hospital - Sutton
London
England
SW3 6JJ
Bristol
BS2 8ED
Royal Bournemouth Hospital
Bournemouth
Dorset
BH7 7DW
Churchill Hospital
Oxford
OX3 7LE
Sheffield
S10 2SJ
Glasgow
G12 0YN
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Stoke-on-Trent
ST4 6QG
Research Site
Cardiff.
CF14 2TL
Trial Contact(s)
Primary Trial Contact
AstraZeneca Clinical Study Information Center
1-877-240-9479
Other Trial Contacts
For information regarding US sites contact NRG Oncology Clinical Coordinating Department 1-800-477-7227
Countries Recruiting
Argentina, Australia, Austria, Belgium, Canada, China, France, Germany, Hungary, Iceland, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Portugal, Puerto Rico, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
A Randomised, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With gBRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy
EudraCT Number
Not available for this trial
Funder(s)
  • Breast International Group
  • Frontier Science & Technology Research Foundation, Inc.
  • NRG Oncology
  • Myriad Genetic Laboratories, Inc.
  • Br.E.A.S.T. -Data Center & Operational Office Institut Jules Bordet
Other Study ID Numbers
D081CC00006
Sponsor(s)
AstraZeneca
Key Dates

Recruitment Start Date

Apr 2014

Recruitment End Date

Mar 2020

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date added to source

03 Jan 2014

Date updated in source

08 Nov 2017