Breast Cancer Clinical Trial

Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments

Summary

Comparison of olaparib vs. physician's choice of single agent standard of care non-platinum based chemotherapy in patients with germline Breast Cancer susceptibility gene (gBRCA) mutated ovarian cancer who have progressed at least 6 months after the last platinum based chemotherapy. Patient should have received at least 2 prior lines of platinum based chemotherapy. The aim of the study is to assess the efficacy and safety of olaparib tablets.

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Full Description

This open label, randomised, controlled, multi-centre study will assess the efficacy and safety of single agent olaparib vs. standard of care, based on physician's choice of single agent chemotherapy ( i.e paclitaxel, or topotecan, or pegylated liposomal doxorubicin, or gemcitabine) in platinum sensitive or partially platinum sensitive relapsed ovarian cancer patients who carry germline deleterious or suspected deleterious BRCA mutation and who have received at least 2 prior lines of platinum based chemotherapy. Patients are eligible to undergo BRCA testing even if they have not yet had recurrence or progression of disease >6 months (>/=183 days) after completion of their last platinum therapy.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patients must be ≥ 18 years of age
Patients with histologically diagnosed relapsed high grade serous ovarian cancer (including primary peritoneal and/or fallopian tube cancer) or high grade endometrioid cancer. Patients are eligible to undergo BRCA testing even if they have not yet had recurrence or progression of disease >6 months (>/=183 days) after completion of their last platinum therapy.
Documented germline mutation in Breast Cancer susceptibility genes: BRCA1 and/or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)
At least one lesion that can be accurately assessed at baseline by CT/MRI and is suitable for repeated assessment.
Patients must have received at least 2 prior platinum based lines of chemotherapy - Patients must be partially platinum sensitive or platinum sensitive
Patients must be suitable to start treatment with single agent chemotherapy based on physician's choice
Patients must have normal organ and bone marrow function measured within 28 days of randomisation,
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Patients must have a life expectancy ≥ 16 weeks
Formalin fixed, paraffin embedded tumour sample from the primary or recurrent cancer must be available for central testing.

Exclusion Criteria:

BRCA 1 and/or BRCA2 mutations that are considered to be non detrimental
Exposure to any investigational product within 30 days or 5 half lives (whichever is longer) prior to randomisation
Any previous treatment with a Polyadenosine 5'diphosphoribose polymerisation (PARP) inhibitor, including olaparib.
Patients who have platinum resistant or refractory disease
Patients receiving any systemic chemotherapy within 3 weeks prior to first dose of study treatment
Previous single agent exposure to the selected chemotherapy regimen for randomisation. - Prior malignancy in the last 5 years, unless curatively treated and recurrence free (few exceptions apply).

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

266

Study ID:

NCT02282020

Recruitment Status:

Completed

Sponsor:

AstraZeneca

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There are 93 Locations for this study

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Birmingham Alabama, 35233, United States
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Mobile Alabama, 36604, United States
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Sacramento California, 95817, United States
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San Francisco California, 94118, United States
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Aurora Colorado, 80045, United States
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Littleton Colorado, 80120, United States
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Hartford Connecticut, 06106, United States
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Fort Gordon Georgia, 30905, United States
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Covington Louisiana, 70433, United States
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Towson Maryland, 21204, United States
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Detroit Michigan, 48201, United States
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Albany New York, 12208, United States
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Mineola New York, 11501, United States
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Chapel Hill North Carolina, 27599, United States
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Columbus Ohio, 43210, United States
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Springfield Oregon, 97477, United States
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Abington Pennsylvania, 19001, United States
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Knoxville Tennessee, 37920, United States
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Nashville Tennessee, 37232, United States
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Bedford Texas, 76022, United States
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Houston Texas, 77030, United States
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Milwaukee Wisconsin, 53226, United States
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Berazategui , B1884, Argentina
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Caba , C1280, Argentina
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Ciudad de Buenos Aires , C1180, Argentina
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Cordoba , 5000, Argentina
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La Plata , B1897, Argentina
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San Miguel de Tucumán , T4000, Argentina
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Gent , 9000, Belgium
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Leuven , 3000, Belgium
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Ijui , 98700, Brazil
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Passo Fundo , 99010, Brazil
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Porto Alegre , 90035, Brazil
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Porto Alegre , 90610, Brazil
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Rio de Janeiro , 22793, Brazil
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Sao Paulo , 01246, Brazil
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Sao Paulo , 01317, Brazil
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São José do Rio Preto , 15090, Brazil
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Toronto Ontario, M4N 3, Canada
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Toronto Ontario, M5G 1, Canada
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Montreal Quebec, H2L 4, Canada
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Hradec Kralove , 500 0, Czechia
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Ostrava-Poruba , 708 5, Czechia
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Praha 2 , 128 0, Czechia
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Zlin , 762 7, Czechia
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Budapest , 1088, Hungary
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Budapest , 1115, Hungary
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Budapest , 1122, Hungary
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Debrecen , 4032, Hungary
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Győr , 9024, Hungary
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Miskolc , 3526, Hungary
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Afula , 18101, Israel
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Haifa , 31096, Israel
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Holon , 58100, Israel
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Jerusalem , 91031, Israel
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Jerusalem , 91120, Israel
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Petah Tikva , 49414, Israel
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Ramat Gan , 52621, Israel
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Rehovot , 76610, Israel
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Tel Hashomer , 52621, Israel
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Tel-Aviv , 64239, Israel
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Zerifin , 70300, Israel
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Meldola , 47014, Italy
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Messina , 98158, Italy
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Milano , 20132, Italy
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Milano , 20133, Italy
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Milano , 20141, Italy
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Napoli , 80131, Italy
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Roma , 00144, Italy
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Roma , 00168, Italy
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Goyang-si , 10408, Korea, Republic of
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Seoul , 03080, Korea, Republic of
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Seoul , 06273, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Seoul , 138-7, Korea, Republic of
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Seoul , 139-7, Korea, Republic of
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Mexico , 07760, Mexico
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Mexico , 6760, Mexico
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Oaxaca , 68000, Mexico
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Gdańsk , 80-21, Poland
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Grzepnica , 72-00, Poland
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Lublin , 20-09, Poland
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Olsztyn , 10-56, Poland
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Poznan , 60-56, Poland
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Warszawa , 02-78, Poland
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Łódź , 93-51, Poland
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Barcelona , 08035, Spain
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Barcelona , 08036, Spain
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Barcelona , 08907, Spain
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Córdoba , 14004, Spain
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Gerona , 17007, Spain
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Granada , 18014, Spain
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Madrid , 28040, Spain
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Madrid , 28050, Spain

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

266

Study ID:

NCT02282020

Recruitment Status:

Completed

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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