Breast Cancer Clinical Trial
Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer.(MONALEESA-2)
Summary
This is a multi-center, randomized, double-blinded, placebo controlled trial.
Full Description
The primary purpose of this study was to assess the efficacy of LEE011, as measured by progression free survival (PFS), in postmenopausal women with HR positive, HER2 negative advanced breast cancer who received no prior treatment for advanced disease.
Eligibility Criteria
Inclusion Criteria:
Women with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
Patient is postmenopausal. Postmenopausal status is defined either by:
Prior bilateral oophorectomy
Age ≥60
Age <60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range Note: For women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol are needed to ensure postmenopausal status. Ovarian radiation or treatment with a luteinizing hormone-releasing hormone agonist (LH-RHa) (goserelin acetate or leuprolide acetate) is not permitted for induction of ovarian suppression in this trial.
No prior systemic anti-cancer therapy for advanced disease.
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory.
Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
Patient must have either:
• Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria (Tumor lesions previously irradiated or subjected to other locoregional therapy will only be considered measurable if disease progression at the treated site after completion of therapy is clearly documented).
OR
• If no measurable disease is present, then at least one predominantly lytic bone lesion must be present (Patients with no measurable disease and only one predominantly lytic bone lesion that has been previously irradiated are eligible if there is documented evidence of disease progression of the bone lesion after irradiation).
Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Exclusion Criteria:
Patient who received any CDK4/6 inhibitor.
Patient who received any prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy) for advanced breast cancer
Note:
Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior neo (adjuvant) therapy included letrozole or anastrozole the disease free interval must be greater than 12 months from the completion of treatment until randomization.
Patients who received ≤ 14 days of letrozole or anastrozole for advanced disease prior to randomization are eligible.
Any prior (neo) adjuvant anti-cancer therapy must be stopped at least 5 half-lives or 7 days, whichever is longer, before randomization
Patient is concurrently using other anti-cancer therapy.
Patient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
Patient has active cardiac disease or a history of cardiac dysfunction including any of the following:
History of angina pectoris, symptomatic pericarditis, or myocardial infarction within 12 months prior to study entry
History of documented congestive heart failure (New York Heart Association functional classification III-IV)
Documented cardiomyopathy
Patient has a Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO)
History of any cardiac arrhythmias, e.g., ventricular, supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months.
On screening, any of the following cardiac parameters:
bradycardia (heart rate < 50 at rest), tachycardia (heart rate > 90 at rest), PR interval > 220 msec, QRS interval >109 msec, or QTcF >450 msec.
Systolic blood pressure >160 or <90 mmHg
6. Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior start if the treatment:
That are known strong inducers or inhibitors of CYP3A4.
That have a known risk to prolong the QT interval or induce Torsades de Pointes.
That have a narrow therapeutic window and are predominantly metabolized through CYP3A4.
Herbal preparations/medications
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There are 218 Locations for this study
Chandler Arizona, 85224, United States
Sedona Arizona, 86336, United States
Fayetteville Arkansas, 72703, United States
Jonesboro Arkansas, 72401, United States
Berkeley California, 94704, United States
Duarte California, 91010, United States
Glendale California, 91206, United States
Los Angeles California, 90025, United States
Los Angeles California, 90048, United States
Sacramento California, 95817, United States
Aurora Colorado, 80045, United States
Longmont Colorado, 80501, United States
Boynton Beach Florida, 33426, United States
Davie Florida, 33328, United States
Fort Myers Florida, 33901, United States
Hollywood Florida, 33021, United States
Miami Florida, 33136, United States
Orlando Florida, 32804, United States
Orlando Florida, 32804, United States
Pensacola Florida, 32504, United States
Saint Petersburg Florida, 33705, United States
Decatur Georgia, 30033, United States
Thomasville Georgia, 31792, United States
Honolulu Hawaii, 96817, United States
Chicago Illinois, 60612, United States
Chicago Illinois, 60637, United States
Evanston Illinois, 60201, United States
Harvey Illinois, 60426, United States
Naperville Illinois, 60540, United States
Indianapolis Indiana, 46202, United States
Baltimore Maryland, 21231, United States
Frederick Maryland, 21701, United States
Boston Massachusetts, 02215, United States
Minneapolis Minnesota, 55407, United States
Jackson Mississippi, 39202, United States
Kansas City Missouri, 64111, United States
Manchester Missouri, 63021, United States
Nashua New Hampshire, 03060, United States
Brick New Jersey, 08724, United States
Camden New Jersey, 08103, United States
New Brunswick New Jersey, 08901, United States
Bronx New York, 10467, United States
Glens Falls New York, 12801, United States
Mineola New York, 11501, United States
New York New York, 10016, United States
New York New York, 10029, United States
Durham North Carolina, 27710, United States
Cincinnati Ohio, 45242, United States
Columbus Ohio, 43221, United States
Oklahoma City Oklahoma, 73120, United States
Allentown Pennsylvania, 18103, United States
Hershey Pennsylvania, 17033, United States
Sioux Falls South Dakota, 57105, United States
Chattanooga Tennessee, 37404, United States
Nashville Tennessee, 37203, United States
Nashville Tennessee, 37232, United States
Bedford Texas, 76022, United States
Dallas Texas, 75251, United States
Dallas Texas, 75390, United States
Fort Worth Texas, 76104, United States
Fort Worth Texas, 76104, United States
Houston Texas, 77024, United States
Houston Texas, 77030, United States
Houston Texas, 77090, United States
McAllen Texas, 78503, United States
Richardson Texas, 75082, United States
San Antonio Texas, 78217, United States
Tyler Texas, 75702, United States
Salt Lake City Utah, 84106, United States
Fairfax Virginia, 22031, United States
Salem Virginia, 24153, United States
Everett Washington, 98201, United States
Tacoma Washington, 98405, United States
Madison Wisconsin, 53717, United States
San Miguel De Tucuman Tucuman, T4000, Argentina
Cordoba , X5002, Argentina
La Rioja , 5300, Argentina
Kurralta Park South Australia, 5037, Australia
East Melbourne Victoria, 3002, Australia
Nedlands Western Australia, 6009, Australia
Salzburg , 5020, Austria
Vienna , A-110, Austria
Wien , A-109, Austria
Sint Niklaas Vlaams Brabant, 9100, Belgium
Hasselt , 3500, Belgium
Leuven , 3000, Belgium
Namur , 5000, Belgium
Wilrijk , 2610, Belgium
Ribeirao Preto SP, 14048, Brazil
Sao Paulo SP, 01246, Brazil
Sao Paulo SP, 01317, Brazil
Burnaby British Columbia, V5G 2, Canada
Halifax Nova Scotia, B3H 1, Canada
Hamilton Ontario, L8V 5, Canada
Kitchener Ontario, N2G 1, Canada
Ottawa Ontario, K1H 8, Canada
Toronto Ontario, M4N 3, Canada
Montreal Quebec, H2W 1, Canada
Quebec , G1S 4, Canada
Brno Bohunice Czech Republic, 625 0, Czechia
Brno Czech Republic, 656 5, Czechia
Liberec Czech Republic, 46063, Czechia
Olomouc CZE, 775 2, Czechia
Aarhus , DK-80, Denmark
Copenhagen , DK-21, Denmark
Odense C , DK 50, Denmark
Vejle , 7100, Denmark
Helsinki , 00029, Finland
Turku , FIN-2, Finland
Nice Cedex 2 Alpes Maritimes, 06189, France
Villejuif Cedex Villejuif, 94800, France
Angers Cedex 02 , 49055, France
Avignon Cedex , 84082, France
Besancon Cedex , 25030, France
Bordeaux Cedex , 33000, France
Creteil , 94000, France
Le Mans Cedex , 72015, France
Lyon Cedex , 69373, France
Pierre Benite Cedex , 69495, France
Rouen Cedex 1 , 76038, France
Saint-Herblain Cédex , 44805, France
Recklinghausen North Rhine-westphalia, 45657, Germany
Aschaffenburg , 63739, Germany
Berlin , 14169, Germany
Berlin , 14195, Germany
Bielefeld , 33604, Germany
Bonn , 53111, Germany
Bottrop , 46236, Germany
Duesseldorf , 40225, Germany
Erlangen , 91054, Germany
Essen , 45136, Germany
Freiburg , 79110, Germany
Fuerth , 90766, Germany
Goslar , 38642, Germany
Heidelberg , 69120, Germany
Muenchen , 80335, Germany
Offenbach , 63069, Germany
Ravensburg , 88214, Germany
Tübingen , 72076, Germany
Ulm , 89081, Germany
Velbert , 42551, Germany
Budapest , 1134, Hungary
Debrecen , 4032, Hungary
Gyor , H-902, Hungary
Gyula , 5700, Hungary
Cork , , Ireland
Dublin 4 , 4, Ireland
Petach Tikva , 49414, Israel
Ramat Gan , 52621, Israel
Tel Aviv , 64239, Israel
Brescia BS, 25123, Italy
Genova GE, 16132, Italy
Lecco LC, 23900, Italy
Macerata MC, 62100, Italy
Messina ME, 98158, Italy
Milano MI, 20133, Italy
Padova PD, 35100, Italy
Perugia PG, 06129, Italy
Pisa PI, 56126, Italy
Aviano PN, 33081, Italy
Reggio Calabria RC, 89124, Italy
Roma RM, 00168, Italy
Candiolo TO, 10060, Italy
Terni TR, 05100, Italy
Viterbo VT, 01100, Italy
Napoli , 80131, Italy
Bundang Gu Gyeonggi Do, 13620, Korea, Republic of
Gyeonggi do Korea, 10408, Korea, Republic of
Seoul Korea, 05505, Korea, Republic of
Seoul , 03080, Korea, Republic of
Seoul , 03722, Korea, Republic of
Ashrafieh , 16683, Lebanon
Beirut , 1107 , Lebanon
Beirut , , Lebanon
Saida , 652, Lebanon
Maastricht AZ, 5800, Netherlands
Alkmaar , 1815 , Netherlands
Amsterdam , 1066 , Netherlands
Deventer , 7416 , Netherlands
Groningen , 9713 , Netherlands
Groningen , 9728 , Netherlands
Leiden , 2300 , Netherlands
Sittard-Geleen , 6162 , Netherlands
Tilburg , 5042 , Netherlands
Zwolle , 8025 , Netherlands
Bergen , 5021, Norway
Oslo , 0407, Norway
Arkhangelsk , 16304, Russian Federation
Nizhniy Novgorod , , Russian Federation
Ryazan , 39001, Russian Federation
Singapore , 16961, Singapore
Pretoria Gauteng, 0081, South Africa
Malaga Andalucia, 29010, Spain
Sevilla Andalucia, 41013, Spain
Barcelona Catalunya, 08035, Spain
Hospitalet de LLobregat Catalunya, 08907, Spain
Barcelona Cataluña, 08024, Spain
Valencia Comunidad Valenciana, 46009, Spain
Santiago de Compostela Galicia, 15706, Spain
La Laguna Santa Cruz De Tenerife, 38320, Spain
Madrid , 28009, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Madrid , 28046, Spain
Eskilstuna , SE-63, Sweden
Goteborg , 413 4, Sweden
Joenkoeping , 551 8, Sweden
Lund , 221 8, Sweden
Uppsala , SE-75, Sweden
Vaxjo , SE-35, Sweden
Kuei-Shan Chiang Taoyuan/ Taiwan ROC, 33305, Taiwan
New Taipei City TWN, 23561, Taiwan
Kaohsiung , 80756, Taiwan
Taipei , 10048, Taiwan
Taipei , 11217, Taiwan
Bangkok , 10330, Thailand
Ankara , 06100, Turkey
Ankara , 06590, Turkey
Diyarbakir , 21000, Turkey
Istanbul , 34303, Turkey
Izmir , 35040, Turkey
Truro Cornwall, TR1 3, United Kingdom
Newcastle upon Tyne , NE7 7, United Kingdom
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