Breast Cancer Clinical Trial

Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002)

Summary

This study will evaluate the efficacy and safety of olaparib (MK-7339) monotherapy in participants with multiple types of advanced cancer (unresectable and/or metastatic) that: 1) have progressed or been intolerant to standard of care therapy; and 2) are positive for homologous recombination repair mutation (HRRm) or homologous recombination deficiency (HRD).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

For all participants:
Has measurable disease per RECIST 1.1 or PCWG-modified RECIST 1.1 as assessed by the local site Investigator/radiology and confirmed by BICR.
Is able to provide a newly obtained core or excisional biopsy of a tumor lesion or either an archival formalin-fixed paraffin embedded (FFPE) tumor tissue block or slides.
Has a life expectancy of at least 3 months.
Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1, as assessed within 7 days of treatment initiation.
Male participants must agree to use contraception during the treatment period and for at least 95 days (3 months and 5 days) after the last dose of study treatment and refrain from donating sperm during this period.

A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

Is not a woman of childbearing potential (WOCBP).
Is a WOCBP and using a contraceptive method that is highly effective with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 180 days after the last dose of study intervention, AND agrees not to donate eggs (ova, oocytes) to others or freeze/store for her own use for the purpose of reproduction during this period. Abstains from breastfeeding during the study intervention period and for at least 30 days after the last dose of study intervention.
Has adequate organ function.
For participants who have non-breast or -ovarian cancers that are breast cancer susceptibility gene 1/2 (BRCA1/2) mutated (BRCAm), or who have cancers that are BRCA1/2 non-mutated and homologous recombination repair nonmutated:
Has a histologically- or cytologically-confirmed advanced (metastatic and/or unresectable) solid tumor (except ovarian cancer whose tumor has a germline or somatic BRCA mutation and breast cancer whose tumor has a germline BRCA mutation) that is not eligible for curative treatment and for which standard of care therapy has failed. Participants must have progressed on or be intolerant to standard of care therapies that are known to provide clinical benefit. There is no limit on the number of prior treatment regimens.
Has either centrally-confirmed known or suspected deleterious mutations in at least 1 of the genes involved in HRR or centrally-confirmed HRD.
For participants receiving prior platinum (cisplatin, carboplatin, or oxaliplatin either as monotherapy or in combination) for advanced (metastatic and/or unresectable) solid tumor, have no evidence of disease progression during the platinum chemotherapy or ≤4 weeks of completing the platinum-containing regimen.
For participants who have somatic BRCAm breast cancer:
Has histologically- or cytologically-confirmed breast cancer with evidence of metastatic disease.
Has a known or suspected deleterious mutation in breast cancer susceptibility gene (BRCA) 1 or BRCA2 and does not harbor a germline BRCA1 or BRCA2 mutation - testing can be done centrally or locally. Blood and tissue samples must be provided by all participants.
Has received treatment with an anthracycline unless contraindicated and a taxane in either the neoadjuvant/adjuvant or metastatic setting.
Participants with estrogen and/or progesterone receptor-positive disease 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.

Exclusion Criteria:

Has a known additional malignancy that is progressing or has required active treatment in the last 5 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, ductal carcinoma in situ, or cervical carcinoma in situ that has undergone potentially curative therapy are not excluded.
Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
Has known central nervous system (CNS) metastases and/or carcinomatous meningitis. Note: Participants with previously treated brain metastases may participate if radiologically stable, clinically stable, and without requirement for steroid treatment for at least 14 days prior to the first dose of study treatment.
Has received colony-stimulating factors (e.g., granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 28 days prior to the first dose of study treatment.
Has a known history of human immunodeficiency virus (HIV) infection.
Has known active hepatitis infection (i.e., Hepatitis B or C).
Is unable to swallow orally administered medication or has a gastrointestinal disorder affecting absorption (e.g., gastrectomy, partial bowel obstruction, malabsorption).
Has received prior therapy with olaparib or with any other polyadenosine 5' diphosphoribose (poly[ADP ribose]) polymerization (PARP) inhibitor.
Has a known hypersensitivity to the components or excipients in olaparib.
Has received previous allogenic bone-marrow transplant or double umbilical cord transplantation (dUCBT).
Has received a whole blood transfusion in the last 120 days prior to entry to the study. Packed red blood cells and platelet transfusions are acceptable if not performed within 28 days of the first dose of study treatment.
Has received any anti-neoplastic systemic chemotherapy or biological therapy, targeted therapy, or an anticancer hormonal therapy within 3 weeks prior to the first dose of study intervention.
Has a primary cancer of unknown origin.
Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

390

Study ID:

NCT03742895

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 126 Locations for this study

See Locations Near You

The University of Arizona Cancer Center - North Campus ( Site 0011)
Tucson Arizona, 85721, United States
St Joseph Heritage Healthcare-Oncology ( Site 0056)
Fullerton California, 92835, United States
Cedars Sinai Medical Center ( Site 0002)
Los Angeles California, 90048, United States
UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0007)
San Francisco California, 94158, United States
Rocky Mountain Regional Veterans Affairs Medical Center ( Site 0092)
Aurora Colorado, 80045, United States
Winship Cancer Institute of Emory University ( Site 0025)
Atlanta Georgia, 30322, United States
Augusta University ( Site 0028)
Augusta Georgia, 30912, United States
Markey Cancer Center ( Site 0018)
Lexington Kentucky, 40536, United States
University of Maryland ( Site 0050)
Baltimore Maryland, 21201, United States More Info
Study Coordinator
Contact
410-328-7224
Weinberg Cancer Institute at Franklin Square ( Site 0054)
Baltimore Maryland, 21237, United States
University of Massachusetts ( Site 0017)
Worcester Massachusetts, 01655, United States
Henry Ford Health System ( Site 0060)
Detroit Michigan, 48202, United States
Cancer Partners of Nebraska ( Site 0051)
Lincoln Nebraska, 68510, United States More Info
Study Coordinator
Contact
402-327-7363
Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0116)
Middletown New Jersey, 07748, United States More Info
Study Coordinator
Contact
646-888-5089
Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 0126)
Harrison New York, 10604, United States More Info
Study Coordinator
Contact
646-888-5089
VA New York Harbor Healthcare System Manhattan ( Site 0094)
New York New York, 10010, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0057)
New York New York, 10016, United States
Memorial Sloan Kettering Cancer Center ( Site 0026)
New York New York, 10065, United States More Info
Study Coordinator
Contact
646-888-5089
Southwestern Regional Medical Center, Inc. ( Site 0079)
Tulsa Oklahoma, 74133, United States
Eastern Regional Medical Center, Inc. ( Site 0077)
Philadelphia Pennsylvania, 19124, United States
Sanford Hematology Oncology-Sioux Falls SD ( Site 0012)
Sioux Falls South Dakota, 57104, United States More Info
Study Coordinator
Contact
605-328-8000
Intermountain Healthcare ( Site 0043)
Saint George Utah, 84790, United States
Virginia Mason Medical Center ( Site 0052)
Seattle Washington, 98101, United States
Veterans Affairs Puget Sound Health Care System [Seattle, WA] ( Site 0093)
Seattle Washington, 98108, United States More Info
Study Coordinator
Contact
206-277-3101
Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 2703)
Berazategui Buenos Aires, B1884, Argentina More Info
Study Coordinator
Contact
541142262013
Hospital Britanico de Buenos Aires ( Site 2704)
Ciudad de Buenos Aires Caba, C1280, Argentina
Instituto de Investigaciones Metabolicas ( Site 2700)
Buenos Aires , C1012, Argentina More Info
Study Coordinator
Contact
+541146356624
Hospital Aleman ( Site 2702)
Buenos Aires , C1118, Argentina More Info
Study Coordinator
Contact
+54 11 4827-7000
Kinghorn Cancer Centre ( Site 2200)
Darlinghurst New South Wales, 2010, Australia More Info
Study Coordinator
Contact
+61293555655
MNCCI Port Macquarie Base Hospital ( Site 2201)
Port Macquarie New South Wales, 2444, Australia
Linear Clinical Research Ltd ( Site 2202)
Nedlands Western Australia, 6009, Australia More Info
Study Coordinator
Contact
+61864573333
Sunnybrook Health Science Centre ( Site 0210)
Toronto Ontario, M4N 3, Canada More Info
Study Coordinator
Contact
4164805000
Hopital Maisonneuve-Rosemont CIUSSS de l Est de L Ile de Montreal ( Site 0203)
Montreal Quebec, H1T 2, Canada More Info
Study Coordinator
Contact
51425234005853
Jewish General Hospital ( Site 0209)
Montreal Quebec, H3T 1, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Quebec City Quebec, G1J 1, Canada
Fundacion Centro de Investigacion Clinica CIC ( Site 2812)
Medellin Antioquia, 05002, Colombia
Rodrigo Botero SAS ( Site 2801)
Medellin Antioquia, 05003, Colombia
Biomelab S A S ( Site 2800)
Barranquilla Atlantico, 08000, Colombia
Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 2808)
Valledupar Cesar, 20000, Colombia More Info
Study Coordinator
Contact
+5755602310
Oncomedica S.A. ( Site 2806)
Monteria Cordoba, 23000, Colombia
Administradora Country SA - Clinica del Country ( Site 2802)
Bogota Distrito Capital De Bogota, 11022, Colombia More Info
Study Coordinator
Contact
5300470 Ext.: 2909
Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 2807)
Bogota Distrito Capital De Bogota, 11031, Colombia
Instituto Nacional de Cancerologia E.S.E ( Site 2809)
Bogota Distrito Capital De Bogota, 11032, Colombia
C. Medico Imbanaco Cali S.A. ( Site 2810)
Cali Valle Del Cauca, 76004, Colombia
Rigshospitalet ( Site 0402)
Copenhagen Hovedstaden, 2100, Denmark More Info
Study Coordinator
Contact
+45 35 45 35 45
Herlev og Gentofte Hospital. ( Site 0401)
Herlev Hovedstaden, 2730, Denmark More Info
Study Coordinator
Contact
+45 38 68 38 68
Odense Universitetshospital ( Site 0400)
Odense Syddanmark, 5000, Denmark
CHU Poitiers ( Site 0612)
Poitiers Ain, 86021, France More Info
Study Coordinator
Contact
+33549441496
Centre Antoine Lacassagne ( Site 0610)
Nice Alpes-Maritimes, 06189, France More Info
Study Coordinator
Contact
+33492031514
Institut de Cancerologie Strasbourg Europe ( Site 0613)
Strasbourg Alsace, 67033, France More Info
Study Coordinator
Contact
+33388252485
Centre Georges Francois Leclerc ( Site 0608)
Dijon Bourgogne, 21000, France More Info
Study Coordinator
Contact
+33380737506
Institut Bergonie ( Site 0603)
Bordeaux Gironde, 33076, France More Info
Study Coordinator
Contact
+33556333333
Institut Gustave Roussy ( Site 0601)
Villejuif Val-de-Marne, 94805, France More Info
Study Coordinator
Contact
+33142114296
Centro Regional de Sub Especialidades Medicas SA ( Site 3003)
Guatemala Quetzaltenango, 09001, Guatemala More Info
Study Coordinator
Contact
+50259450559
Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 3004)
Guatemala , 01010, Guatemala More Info
Study Coordinator
Contact
+50259458053
Integra Cancer Institute ( Site 3006)
Guatemala , 01010, Guatemala More Info
Study Coordinator
Contact
+50222790939
Grupo Angeles SA ( Site 3001)
Guatemala , 01015, Guatemala More Info
Study Coordinator
Contact
+50240492110
Mater Misericordiae University Hospital ( Site 1654)
Dublin Carlow, D07 W, Ireland More Info
Study Coordinator
Contact
+353018034838
Bon Secours Hospital ( Site 1656)
Cork , T12 D, Ireland More Info
Study Coordinator
Contact
+353214345495
St. Vincent's University Hospital ( Site 1653)
Dublin , 00004, Ireland More Info
Study Coordinator
Contact
+35314144259
Tallaght University Hospital ( Site 1652)
Dublin , D24 N, Ireland More Info
Study Coordinator
Contact
+35314144259
Soroka Medical Center ( Site 0800)
Beer-Sheva , 84571, Israel More Info
Study Coordinator
Contact
+97286400060
Rambam Health Care Campus-Oncology Division ( Site 0801)
Haifa , 31096, Israel
Hadassah Ein Kerem Medical Center ( Site 0802)
Jerusalem , 91120, Israel More Info
Study Coordinator
Contact
+97226777825
Chaim Sheba Medical Center ( Site 0803)
Ramat Gan , 52620, Israel More Info
Study Coordinator
Contact
+97235302243
Sourasky Medical Center ( Site 0804)
Tel Aviv , 64239, Israel
Istituto Nazionale Tumori Fondazione Pascale ( Site 0700)
Napoli Campania, 80131, Italy More Info
Study Coordinator
Contact
+390815903431
Istituto Clinico Humanitas Research Hospital ( Site 0703)
Rozzano Lombardia, 20089, Italy More Info
Study Coordinator
Contact
+390282244080
Policlinico Le Scotte di Siena ( Site 0704)
Siena Toscana, 53100, Italy More Info
Study Coordinator
Contact
+390577586335
Aichi Cancer Center Hospital ( Site 2602)
Nagoya Aichi, 464-8, Japan
National Cancer Center Hospital East ( Site 2600)
Kashiwa Chiba, 27785, Japan
Osaka University Hospital ( Site 2604)
Suita Osaka, 565-0, Japan
Kyoto University Hospital ( Site 2603)
Kyoto , 606-8, Japan
National Cancer Center Hospital ( Site 2601)
Tokyo , 104-0, Japan
The Cancer Institute Hospital of JFCR ( Site 2605)
Tokyo , 135-8, Japan
Seoul National University Bundang Hospital ( Site 2402)
Seongnam-si Kyonggi-do, 13620, Korea, Republic of More Info
Study Coordinator
Contact
+82317877022
Seoul National University Hospital ( Site 2401)
Seoul , 03080, Korea, Republic of More Info
Study Coordinator
Contact
+82220720850
Severance Hospital Yonsei University Health System ( Site 2400)
Seoul , 03722, Korea, Republic of
Actualidad Basada en la Investigacion del Cancer ( Site 2903)
Guadalajara Jalisco, 44680, Mexico More Info
Study Coordinator
Contact
+523313141707
Unidad Biomedica Avanzada Monterrey S. A. ( Site 2902)
Monterrey Nuevo Leon, 64460, Mexico
Cuidados Oncologicos ( Site 2908)
Santiago De Quetaro Queretaro, 76000, Mexico More Info
Study Coordinator
Contact
+524422428555
Centro de Estudios de Investigacion Metabolicos y Cardiovasculares ( Site 2901)
Madero Tamaulipas, 89440, Mexico
Centro Estatal de Cancerologia de Chihuahua ( Site 2907)
Chihuahua , 31000, Mexico
CRYPTEX Investigacion Clinica S.A. de C.V. ( Site 2900)
Mexico City , 06100, Mexico More Info
Study Coordinator
Contact
+525555743589
CENEIT Oncologicos ( Site 2904)
Mexico , 03100, Mexico More Info
Study Coordinator
Contact
+5215529009882
Oaxaca Site Management Organization S.C. ( Site 2905)
Oaxaca , 68000, Mexico More Info
Study Coordinator
Contact
+5209515147056
Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 3102)
Trujillo La Libertad, 13001, Peru More Info
Study Coordinator
Contact
+51964820298
Instituto Nacional de Enfermedades Neoplasicas ( Site 3106)
Lima Muni Metro De Lima, 15038, Peru
Hospital Nacional Guillermo Almenara Irigoyen ( Site 3107)
Lima , 15033, Peru More Info
Study Coordinator
Contact
+51983716192
Clinica Internacional Sede San Borja ( Site 3100)
Lima , 15036, Peru More Info
Study Coordinator
Contact
+51999611475
Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 3101)
Lima , 15036, Peru More Info
Study Coordinator
Contact
+5112241598 Ext.121
Oncosalud-Clinical Research ( Site 3108)
Lima , 15036, Peru More Info
Study Coordinator
Contact
+51971232095
Hospital Central de la Fuerza Aerea del Peru ( Site 3104)
Lima , 15046, Peru More Info
Study Coordinator
Contact
+51997346037
Hospital Militar Central Coronel Luis Arias Schereiber ( Site 3105)
Lima , 15076, Peru More Info
Study Coordinator
Contact
+51997468543
Hospital Arzobispo Loayza ( Site 3103)
Lima , 15082, Peru
S.C. Pelican Impex S.R.L Spitalul Clinic Pelican Oradea ( Site 1102)
Oradea Bihor, 41046, Romania
Medisprof ( Site 1107)
Cluj Napoca Cluj, 40064, Romania More Info
Study Coordinator
Contact
+40264705150/51
SC Radiotherapy Center Cluj SRL ( Site 1105)
Comuna Floresti Cluj, 40728, Romania
S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1103)
Craiova Dolj, 20034, Romania More Info
Study Coordinator
Contact
+40727774974
Spitalul PDR Medlife ( Site 1106)
Brasov , 50015, Romania More Info
Study Coordinator
Contact
40724789294
S.C.Focus Lab Plus S.R.L ( Site 1101)
Bucuresti , 02254, Romania More Info
Study Coordinator
Contact
+40721298677
S.C.Gral Medical S.R.L ( Site 1104)
Bucuresti , 03142, Romania
Arkhangelsk Clinical Oncological Dispensary ( Site 1204)
Arkhangelsk Arkhangel Skaya Oblast, 16304, Russian Federation
Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1212)
Chelyabinsk Chelyabinskaya Oblast, 45408, Russian Federation
MEDSI Clinical Hospital on Pyatnitsky Highway-Departmentof Antitumor Drug therapy ( Site 1216)
Krasnogorsk Moskovskaya Oblast, 14344, Russian Federation
N.N. Blokhin NMRCO ( Site 1201)
Moscow Moskva, 11547, Russian Federation
MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 1213)
Moscow Moskva, 12528, Russian Federation
Ryazan Regional Clinical Oncology dispensary ( Site 1202)
Ryazan Ryazanskaya Oblast, 39001, Russian Federation
SBHI Samara Regional Clinical Oncology Dispensary ( Site 1211)
Samara Samarskaya Oblast, 44303, Russian Federation
Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1208)
Saint Petersburg Sankt-Peterburg, 19775, Russian Federation
Clinical Hospital Saint Luka ( Site 1205)
Saint-Petersburg Sankt-Peterburg, 19404, Russian Federation
SBHI Leningrad Regional Clinical Hospital ( Site 1206)
St.Petersburg Sankt-Peterburg, 19429, Russian Federation
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1207)
Kazan Tatarstan, Respublika, 42002, Russian Federation
Hospital Universitario Quiron Madrid ( Site 1352)
Pozuelo de Alarcon Madrid, 28223, Spain More Info
Study Coordinator
Contact
+34914521987
Hospital Universitari Vall d Hebron ( Site 1350)
Barcelona , 08035, Spain More Info
Study Coordinator
Contact
+34934894158
Universitaetsspital Zuerich ( Site 1400)
Zuerich Aargau, 8091, Switzerland More Info
Study Coordinator
Contact
+41442552214
Hopitaux Universitaires de Geneve HUG. ( Site 1406)
Geneva Geneve, 1211, Switzerland More Info
Study Coordinator
Contact
+41795532353
Ospedale Regionale di Bellinzona e Valli ( Site 1407)
Bellinzona Ticino, 6500, Switzerland More Info
Study Coordinator
Contact
+41918118194
Necmettin Erbakan Universitesi Meram Tip Fakultesi ( Site 1507)
Konya Adana, 42080, Turkey More Info
Study Coordinator
Contact
+903322237000
Baskent University Adana Training Hospital ( Site 1508)
Adana , 01250, Turkey More Info
Study Coordinator
Contact
+905353067506
Hacettepe Universitesi Tıp Fakultesi ( Site 1503)
Ankara , 06100, Turkey
Akdeniz Universitesi Tip Fakultesi ( Site 1504)
Antalya , 07070, Turkey More Info
Study Coordinator
Contact
+905052312377
Trakya Universitesi Tip Fakultesi ( Site 1500)
Edirne , 22030, Turkey More Info
Study Coordinator
Contact
+905322480988
Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 1505)
Istanbul , 34098, Turkey More Info
Study Coordinator
Contact
+905052312377
Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 1506)
Istanbul , 34722, Turkey More Info
Study Coordinator
Contact
+902165664000
Ege Universitesi Tip Fakultesi ( Site 1502)
Izmir , 35100, Turkey More Info
Study Coordinator
Contact
+902323903911
Churchill Hospital ( Site 1606)
Oxford Worcestershire, OX3 7, United Kingdom More Info
Study Coordinator
Contact
+441865227212
Christie NHS Foundation Trust ( Site 1601)
Manchester , M20 4, United Kingdom
Northern Centre for Cancer Care ( Site 1602)
Newcastle upon Tyne , NE7 7, United Kingdom More Info
Study Coordinator
Contact
+441912138476
Weston Park Hospital ( Site 1607)
Sheffield , S10 2, United Kingdom More Info
Study Coordinator
Contact
+44114226522

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

390

Study ID:

NCT03742895

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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