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Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations. (OlympiAD)

Primary Purpose

Breast Cancer Metastatic, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation

Status

Active

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Olaparib

Physician's choice chemotherapy

About this trial

This is an interventional treatment trial for Breast Cancer Metastatic focused on measuring Breast Cancer, Metastatic, Olaparib, BRCA, PARP inhibitor, HER2, chemotherapy

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious.
Histologically or cytologically confirmed breast cancer with evidence of metastatic disease.
Prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting.
Prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting at least 12 months from last dose to study entry elapsed.
ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
ECOG performance status 0-1.
Adequate bone marrow, kidney and liver function.

Exclusion Criteria:

Prior treatment with PARP inhibitor.
Patients with HER2 positive disease.
More than 2 prior lines of chemotherapy for metastatic breast cancer.
Untreated and/or uncontrolled brain metastases.
Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, DCIS or stage I grade 1 endometrial cancer allowed.
Known HIV (Human Immunodeficiency Virus) infection.
Pregnant or breast-feeding women.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Olaparib

Physician's choice chemotherapy

Arm Description

Olaparib tablet 300mg bd po

Capecitabine 2500 mg/m2 d1-14 q 21, or Vinorelbine 30 mg/m2 d1,8 q 21, or Eribulin 1.4 mg/m2 d1,8 q 21

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)

Secondary Outcome Measures

Time to Second Progression or Death (PFS2)

Time from randomisation to the earliest of the progression event subsequent to the first objective radiological progression, or death. Second progression may involve any of; objective radiological or symptomatic progression or death. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Symptomatic progression is assessed by investigators based on clinical examination.

Overall Survival (OS)

Time from randomisation until death due to any cause.

Objective Response Rate (ORR) Using Blinded Independent Central Review (BICR) Data Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)

Number of responders according to blinded independent central review (BICR) assessment. Per Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1) for target lesions assessed by CT or MRI: Complete Response (CR) is defined as the disappearance of all target lesions; Partial Response (PR) is defined as >=30% decrease in the sum of the longest diameter of target lesions; Overall Response = CR + PR.

Adjusted Mean Change in Global Health Status/Quality of Life (QoL) Score From the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)

Change from baseline in global health status/quality of life (QoL) score assessed using a mixed model for repeated measures (MMRM) analysis, including all post-baseline global health status/QoL scores up to the latest scheduled visit where at least 20 patients on each treatment arm have a score. Global health status/QoL score is on a scale from 0 to 100. A higher score represents an improved health status/QoL.

Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) in Patients Confirmed as Myriad CDx gBRCAm

Time from randomisation to the earliest of objective radiological progression or death by any cause in the absence of objective progression. Objective radiological progression is defined using Response Evaluation Criteria In Solid Tumours Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Assessed in patients with a deleterious or suspected deleterious variant in either of the BRCA genes using variants identified with current and future BRCA mutation assays (gene sequencing and large rearrangement analysis).

Overall Survival (OS) at Final OS

Time from randomisation until death due to any cause.

Overall Survival (OS) at Extended OS

Time from randomisation until death due to any cause.

Full Information

NCT ID

NCT02000622

First Posted

November 18, 2013

Last Updated

October 9, 2023

Sponsor

AstraZeneca

Collaborators

Myriad Genetic Laboratories, Inc., Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT02000622

Brief Title

Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.

Acronym

OlympiAD

Official Title

A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to Assess the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

March 27, 2014 (Actual)

Primary Completion Date

December 9, 2016 (Actual)

Study Completion Date

December 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

Collaborators

Myriad Genetic Laboratories, Inc., Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2 mutations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer Metastatic, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation

Keywords

Breast Cancer, Metastatic, Olaparib, BRCA, PARP inhibitor, HER2, chemotherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

302 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Olaparib

Arm Type

Experimental

Arm Description

Olaparib tablet 300mg bd po

Arm Title

Physician's choice chemotherapy

Arm Type

Active Comparator

Arm Description

Capecitabine 2500 mg/m2 d1-14 q 21, or Vinorelbine 30 mg/m2 d1,8 q 21, or Eribulin 1.4 mg/m2 d1,8 q 21

Intervention Type

Drug

Intervention Name(s)

Olaparib

Intervention Description

Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.

Intervention Type

Drug

Intervention Name(s)

Physician's choice chemotherapy

Intervention Description

Investigators will declare one of the following regimens: Capecitabine 2500 mg/m2 po daily (divided in 2 doses) x 14 days, repeat every 21 days Vinorelbine 30 mg/m2 IV Day 1 and Day 8, repeat every 21 days Eribulin 1.4 mg/m2 IV Day 1 and Day 8, repeat every 21 days

Primary Outcome Measure Information:

Title

Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)

Description

Time Frame

Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.

Secondary Outcome Measure Information:

Title

Time to Second Progression or Death (PFS2)

Description

Time Frame

Second progression status reviewed every 8 weeks following the first objective radiological progression as per investigator assessment. Assessed up to a maximum of 30 months.

Title

Overall Survival (OS)

Description

Time from randomisation until death due to any cause.

Time Frame

Survival status reviewed every 3 weeks until treatment discontinued, then every 8 weeks. Assessed up to a maximum of 30 months.

Title

Objective Response Rate (ORR) Using Blinded Independent Central Review (BICR) Data Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1)

Description

Time Frame

Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.

Title

Adjusted Mean Change in Global Health Status/Quality of Life (QoL) Score From the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30)

Description

Time Frame

EORTC QLQ-C30 assessments performed at baseline then every ~6 weeks until objective radiological disease progression. Assessed up to a maximum of 30 months.

Title

Description

Time Frame

Radiological scans performed at baseline then every ~6 weeks up to 24 weeks, then every ~ 12 weeks thereafter until objective radiological disease progression. Assessed up to a maximum of 30 months.

Title

Overall Survival (OS) at Final OS

Description

Time from randomisation until death due to any cause.

Time Frame

Survival status reviewed every 3 weeks until treatment discontinued, then every 8 weeks. Assessed up to a maximum of 40 months.

Title

Overall Survival (OS) at Extended OS

Description

Time from randomisation until death due to any cause.

Time Frame

Survival status reviewed every 3 weeks until treatment discontinued, then every 8 weeks until Sep 2017 (final OS DCO), then every 3 months. Assessed up to a maximum of 64 months.

Other Pre-specified Outcome Measures:

Title

Time to First Subsequent Cancer Therapy or Death (TFST)

Description

Time from randomisation to the earliest of first subsequent cancer therapy start date following study treatment discontinuation, or death.

Time Frame

Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation. Assessed up to a maximum of 30 months.

Title

Time to Second Subsequent Cancer Therapy or Death (TSST)

Description

Time from randomisation to the earliest of second subsequent cancer therapy start date following study treatment discontinuation, or death.

Time Frame

Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation. Assessed up to a maximum of 30 months.

Title

Time to First Subsequent Cancer Therapy or Death (TFST) at Extended OS

Description

Time from randomisation to the earliest of first subsequent cancer therapy start date following study treatment discontinuation, or death.

Time Frame

Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation until Sep 2017 (final OS DCO), then every 3 months. Assessed up to a maximum of 64 months.

Title

Time to Second Subsequent Cancer Therapy or Death (TSST) at Extended OS

Description

Time from randomisation to the earliest of second subsequent cancer therapy start date following study treatment discontinuation, or death.

Time Frame

Subsequent cancer therapy status reviewed every 8 weeks following study treatment discontinuation until Sep 2017 (final OS DCO), then every 3 months. Assessed up to a maximum of 64 months.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious. Histologically or cytologically confirmed breast cancer with evidence of metastatic disease. Prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting. Prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting at least 12 months from last dose to study entry elapsed. ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy. ECOG performance status 0-1. Adequate bone marrow, kidney and liver function. Exclusion Criteria: Prior treatment with PARP inhibitor. Patients with HER2 positive disease. More than 2 prior lines of chemotherapy for metastatic breast cancer. Untreated and/or uncontrolled brain metastases. Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, DCIS or stage I grade 1 endometrial cancer allowed. Known HIV (Human Immunodeficiency Virus) infection. Pregnant or breast-feeding women.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Robson, MD

Organizational Affiliation

Memorial Sloan-Kettering Cancer Center, New York

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

Research Site

City

Santa Rosa

State/Province

California

ZIP/Postal Code

95403

Country

United States

Facility Name

Research Site

City

Whittier

State/Province

California

ZIP/Postal Code

90602

Country

United States

Facility Name

Research Site

City

Denver

State/Province

Colorado

ZIP/Postal Code

80204

Country

United States

Facility Name

Research Site

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

Research Site

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20007

Country

United States

Facility Name

Research Site

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32224

Country

United States

Facility Name

Research Site

City

Orlando

State/Province

Florida

ZIP/Postal Code

32804

Country

United States

Facility Name

Research Site

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

Research Site

City

Columbus

State/Province

Georgia

ZIP/Postal Code

31904

Country

United States

Facility Name

Research Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Research Site

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Research Site

City

Niles

State/Province

Illinois

ZIP/Postal Code

60714

Country

United States

Facility Name

Research Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Research Site

City

Lafayette

State/Province

Louisiana

ZIP/Postal Code

70506

Country

United States

Facility Name

Research Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Research Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

Facility Name

Research Site

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02215

Country

United States

Facility Name

Research Site

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Research Site

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

Facility Name

Research Site

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905-0001

Country

United States

Facility Name

Research Site

City

Saint Louis Park

State/Province

Minnesota

ZIP/Postal Code

55416

Country

United States

Facility Name

Research Site

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39202

Country

United States

Facility Name

Research Site

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65212

Country

United States

Facility Name

Research Site

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63131

Country

United States

Facility Name

Research Site

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756

Country

United States

Facility Name

Research Site

City

Commack

State/Province

New York

ZIP/Postal Code

11725

Country

United States

Facility Name

Research Site

City

Harrison

State/Province

New York

ZIP/Postal Code

10604

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10021

Country

United States

Facility Name

Research Site

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Facility Name

Research Site

City

Rockville Centre

State/Province

New York

ZIP/Postal Code

11570

Country

United States

Facility Name

Research Site

City

Syracuse

State/Province

New York

ZIP/Postal Code

13210

Country

United States

Facility Name

Research Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45267

Country

United States

Facility Name

Research Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Research Site

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Research Site

City

Portland

State/Province

Oregon

ZIP/Postal Code

97213

Country

United States

Facility Name

Research Site

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Research Site

City

Sayre

State/Province

Pennsylvania

ZIP/Postal Code

18840

Country

United States

Facility Name

Research Site

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Research Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Research Site

City

Tyler

State/Province

Texas

ZIP/Postal Code

75701

Country

United States

Facility Name

Research Site

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05401

Country

United States

Facility Name

Research Site

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

Research Site

City

Plovdiv

ZIP/Postal Code

4004

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1233

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1303

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1330

Country

Bulgaria

Facility Name

Research Site

City

Sofia

ZIP/Postal Code

1504

Country

Bulgaria

Facility Name

Research Site

City

Varna

ZIP/Postal Code

9010

Country

Bulgaria

Facility Name

Research Site

City

Vratza

ZIP/Postal Code

3000

Country

Bulgaria

Facility Name

Research Site

City

Beijing

ZIP/Postal Code

100006

Country

China

Facility Name

Research Site

City

Beijing

ZIP/Postal Code

100021

Country

China

Facility Name

Research Site

City

Beijing

ZIP/Postal Code

100142

Country

China

Facility Name

Research Site

City

Changchun

ZIP/Postal Code

130061

Country

China

Facility Name

Research Site

City

Changsha

ZIP/Postal Code

410013

Country

China

Facility Name

Research Site

City

Chengdu

ZIP/Postal Code

610041

Country

China

Facility Name

Research Site

City

Dalian

ZIP/Postal Code

116011

Country

China

Facility Name

Research Site

City

Guangzhou

ZIP/Postal Code

510060

Country

China

Facility Name

Research Site

City

Hangzhou

ZIP/Postal Code

310022

Country

China

Facility Name

Research Site

City

Harbin

ZIP/Postal Code

150081

Country

China

Facility Name

Research Site

City

Nanjing

ZIP/Postal Code

210009

Country

China

Facility Name

Research Site

City

Shanghai

ZIP/Postal Code

200025

Country

China

Facility Name

Research Site

City

Shanghai

ZIP/Postal Code

200032

Country

China

Facility Name

Research Site

City

Shenyang

ZIP/Postal Code

110016

Country

China

Facility Name

Research Site

City

Tianjin

ZIP/Postal Code

300060

Country

China

Facility Name

Research Site

City

Brno

ZIP/Postal Code

656 53

Country

Czechia

Facility Name

Research Site

City

Olomouc

ZIP/Postal Code

775 20

Country

Czechia

Facility Name

Research Site

City

Praha 2

ZIP/Postal Code

128 08

Country

Czechia

Facility Name

Research Site

City

Caen Cedex

ZIP/Postal Code

14076

Country

France

Facility Name

Research Site

City

Montpellier

ZIP/Postal Code

34298

Country

France

Facility Name

Research Site

City

Rouen

ZIP/Postal Code

76038

Country

France

Facility Name

Research Site

City

Strasbourg Cedex

ZIP/Postal Code

67065

Country

France

Facility Name

Research Site

City

Villejuif

ZIP/Postal Code

94800

Country

France

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1032

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1115

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1122

Country

Hungary

Facility Name

Research Site

City

Budapest

ZIP/Postal Code

1145

Country

Hungary

Facility Name

Research Site

City

Nyíregyháza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Research Site

City

Veszprém

ZIP/Postal Code

8200

Country

Hungary

Facility Name

Research Site

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Research Site

City

Napoli

ZIP/Postal Code

80131

Country

Italy

Facility Name

Research Site

City

Padova

ZIP/Postal Code

35128

Country

Italy

Facility Name

Research Site

City

Roma

ZIP/Postal Code

00144

Country

Italy

Facility Name

Research Site

City

Roma

ZIP/Postal Code

00168

Country

Italy

Facility Name

Research Site

City

Rozzano

ZIP/Postal Code

20089

Country

Italy

Facility Name

Research Site

City

Chuo-ku

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

Research Site

City

Chuo-ku

ZIP/Postal Code

104-8560

Country

Japan

Facility Name

Research Site

City

Fukuoka-shi

ZIP/Postal Code

811-1395

Country

Japan

Facility Name

Research Site

City

Kagoshima-shi

ZIP/Postal Code

892-0833

Country

Japan

Facility Name

Research Site

City

Nagoya-shi

ZIP/Postal Code

464-8681

Country

Japan

Facility Name

Research Site

City

Osaka-city

ZIP/Postal Code

540-0006

Country

Japan

Facility Name

Research Site

City

Sapporo-shi

ZIP/Postal Code

003-0804

Country

Japan

Facility Name

Research Site

City

Shinagawa-ku

ZIP/Postal Code

142-8666

Country

Japan

Facility Name

Research Site

City

Suita-city

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

Research Site

City

Cheongju-si

ZIP/Postal Code

28644

Country

Korea, Republic of

Facility Name

Research Site

City

Daegu

ZIP/Postal Code

41404

Country

Korea, Republic of

Facility Name

Research Site

City

Incheon

ZIP/Postal Code

21565

Country

Korea, Republic of

Facility Name

Research Site

City

Seongnam-si

ZIP/Postal Code

13620

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

158-710

Country

Korea, Republic of

Facility Name

Research Site

City

Seoul

ZIP/Postal Code

6351

Country

Korea, Republic of

Facility Name

Research Site

City

Estado de México

ZIP/Postal Code

50080

Country

Mexico

Facility Name

Research Site

City

Merida

ZIP/Postal Code

97000

Country

Mexico

Facility Name

Research Site

City

Merida

ZIP/Postal Code

97133

Country

Mexico

Facility Name

Research Site

City

Mexico

ZIP/Postal Code

6760

Country

Mexico

Facility Name

Research Site

City

Mérida

ZIP/Postal Code

97070

Country

Mexico

Facility Name

Research Site

City

San Juan del Rio

ZIP/Postal Code

76800

Country

Mexico

Facility Name

Research Site

City

Cusco

ZIP/Postal Code

CUSCO 01

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 01

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

Lima 18

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 27

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 34

Country

Peru

Facility Name

Research Site

City

Lima

ZIP/Postal Code

LIMA 41

Country

Peru

Facility Name

Research Site

City

San Borja

ZIP/Postal Code

LIMA 41

Country

Peru

Facility Name

Research Site

City

Elbląg

ZIP/Postal Code

82-300

Country

Poland

Facility Name

Research Site

City

Gdańsk

ZIP/Postal Code

80-214

Country

Poland

Facility Name

Research Site

City

Grzepnica

ZIP/Postal Code

72-003

Country

Poland

Facility Name

Research Site

City

Tarnobrzeg

ZIP/Postal Code

39-400

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

01-748

Country

Poland

Facility Name

Research Site

City

Warszawa

ZIP/Postal Code

03-291

Country

Poland

Facility Name

Research Site

City

Łódź

ZIP/Postal Code

93-513

Country

Poland

Facility Name

Research Site

City

Bucharest

ZIP/Postal Code

013811

Country

Romania

Facility Name

Research Site

City

Bucuresti

ZIP/Postal Code

011171

Country

Romania

Facility Name

Research Site

City

Bucuresti

ZIP/Postal Code

030171

Country

Romania

Facility Name

Research Site

City

Cluj Napoca

ZIP/Postal Code

400015

Country

Romania

Facility Name

Research Site

City

Cluj-Napoca

ZIP/Postal Code

400015

Country

Romania

Facility Name

Research Site

City

Arkhangelsk

ZIP/Postal Code

163045

Country

Russian Federation

Facility Name

Research Site

City

Ivanovo

ZIP/Postal Code

153040

Country

Russian Federation

Facility Name

Research Site

City

Moscow

ZIP/Postal Code

115478

Country

Russian Federation

Facility Name

Research Site

City

Omsk

ZIP/Postal Code

644013

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

195257

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

195271

Country

Russian Federation

Facility Name

Research Site

City

Saint Petersburg

ZIP/Postal Code

197022

Country

Russian Federation

Facility Name

Research Site

City

Saransk

ZIP/Postal Code

430005

Country

Russian Federation

Facility Name

Research Site

City

St-Petersburg

ZIP/Postal Code

197758

Country

Russian Federation

Facility Name

Research Site

City

St.Petersburg

ZIP/Postal Code

191014

Country

Russian Federation

Facility Name

Research Site

City

Yaroslavl

ZIP/Postal Code

150054

Country

Russian Federation

Facility Name

Research Site

City

Barcelona

ZIP/Postal Code

08003

Country

Spain

Facility Name

Research Site

City

Córdoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Research Site

City

Granada

ZIP/Postal Code

18014

Country

Spain

Facility Name

Research Site

City

Madrid

ZIP/Postal Code

28034

Country

Spain

Facility Name

Research Site

City

Majadahonda

ZIP/Postal Code

28222

Country

Spain

Facility Name

Research Site

City

Oviedo

ZIP/Postal Code

33011

Country

Spain

Facility Name

Research Site

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Research Site

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Research Site

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Research Site

City

Bern

ZIP/Postal Code

CH-3010

Country

Switzerland

Facility Name

Research Site

City

Lausanne

ZIP/Postal Code

CH-1011

Country

Switzerland

Facility Name

Research Site

City

Zürich

ZIP/Postal Code

8063

Country

Switzerland

Facility Name

Research Site

City

Kaohsiung

ZIP/Postal Code

80756

Country

Taiwan

Facility Name

Research Site

City

Taichung

ZIP/Postal Code

407

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

10048

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

10449

Country

Taiwan

Facility Name

Research Site

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Research Site

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Research Site

City

Adana

ZIP/Postal Code

1260

Country

Turkey

Facility Name

Research Site

City

Ankara

ZIP/Postal Code

06230

Country

Turkey

Facility Name

Research Site

City

Edirne

ZIP/Postal Code

22030

Country

Turkey

Facility Name

Research Site

City

Gaziantep

ZIP/Postal Code

27310

Country

Turkey

Facility Name

Research Site

City

Istanbul

ZIP/Postal Code

34390

Country

Turkey

Facility Name

Research Site

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

Facility Name

Research Site

City

Kayseri

ZIP/Postal Code

38039

Country

Turkey

Facility Name

Research Site

City

Konya

ZIP/Postal Code

42080

Country

Turkey

Facility Name

Research Site

City

Mersin

ZIP/Postal Code

33110

Country

Turkey

Facility Name

Research Site

City

Aberdeen

ZIP/Postal Code

AB25 2ZN

Country

United Kingdom

Facility Name

Research Site

City

Colchester

ZIP/Postal Code

CO4 5JL

Country

United Kingdom

Facility Name

Research Site

City

Coventry

ZIP/Postal Code

CV2 2DX

Country

United Kingdom

Facility Name

Research Site

City

London

ZIP/Postal Code

W6 8RF

Country

United Kingdom

Facility Name

Research Site

City

Manchester

ZIP/Postal Code

M20 4BX

Country

United Kingdom

Facility Name

Research Site

City

Plymouth

ZIP/Postal Code

PL6 8DH.

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing URL

https://astrazenecagroup-dt.pharmacm.com/DT/Home

Citations:

PubMed Identifier

28578601

Citation

Robson M, Im SA, Senkus E, Xu B, Domchek SM, Masuda N, Delaloge S, Li W, Tung N, Armstrong A, Wu W, Goessl C, Runswick S, Conte P. Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation. N Engl J Med. 2017 Aug 10;377(6):523-533. doi: 10.1056/NEJMoa1706450. Epub 2017 Jun 4. Erratum In: N Engl J Med. 2017 Oct 26;377(17 ):1700.

Results Reference

derived

Links:

URL

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1910&filename=D0819C00003_Clinical_Study_Protocol_Final_redacted.pdf

Description

Redacted Protocol

Learn more about this trial

Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.

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Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations. (OlympiAD)

Breast Cancer Metastatic, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial