Phase
Condition
Neoplasms
Treatment
Exemestane
Fludrocortisone/ Fludrocortisone acetate
Megestrol acetate/Medroxyprogesterone acetate
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Cohort A:
Has a diagnosis of hormone receptor positive/Human Epidermal Growth FactorReceptor 2 negative (HR+/HER2-) invasive breast carcinoma that is eitherlocally advanced disease not amenable to resection with curative intent (hereincalled unresectable) or metastatic disease not treatable with curative intent.
Has experienced disease progression on or after at least 1 priorendocrine-based therapy in the metastatic setting and received either, 1 lineof an approved protocol-specified combination endocrine-based therapy, or 2 ormore lines of protocol-specified endocrine-based therapy in the metastaticsetting
Cohort B:
Has histologically confirmed high-grade epithelial (including high-grade serousor predominantly serous, high-grade endometrioid, malignant mixed Mülleriantumors [carcinosarcoma], or clear cell) ovarian, fallopian tube, or primaryperitoneal carcinoma.
Has received between 4 to 8 cycles of platinum-based doublet chemotherapy inthird-line (3L) setting for ovarian cancer.
Cohort C:
Histologically confirmed diagnosis of primary advanced or recurrent low-gradeendometrioid carcinoma (eg, Federation of Gynecology and Obstetrics [FIGO]Grade 1/2, or well/moderately differentiated).
Treatment naïve or has received up to 1 prior line of platinum-based therapy ineither the advanced/metastatic OR adjuvant/neoadjuvant setting.
All Cohorts :
Participants who have AEs due to previous anticancer therapies must haverecovered to ≤Grade 1 or baseline.
Human immunodeficiency virus (HIV)-infected participants must have wellcontrolled HIV on antiretroviral therapy.
Participants who are Hepatitis B surface antigen positive are eligible if theyhave received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeksand have undetectable HBV viral load.
Participants with a history of Hepatitis C virus (HCV) infection are eligibleif HCV viral load is undetectable.
Exclusion
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
Cohort A:
Breast cancer amenable to treatment with curative intent.
Has advanced/metastatic, symptomatic visceral spread at risk of rapidlyevolving into life-threatening complications, such as lymphangitic lungmetastases, radiographic evidence of intratumoral cavitation orinvasion/infiltration of a major blood vessel, bone marrow replacement,carcinomatous meningitis, significant symptomatic liver metastases, symptomaticpericardial effusion, symptomatic peritoneal carcinomatosis, or the need toachieve rapid symptom control.
Cohort B:
Has nonepithelial cancers (germ cell tumors and sex cord-stromal tumors),borderline tumors (low malignant potential), mucinous, seromucinous that ispredominantly mucinous, malignant Brenner's tumor, low-grade serous, low-gradeendometrioid, and undifferentiated carcinoma.
Has platinum-resistant ovarian cancer (defined as disease that has progressedper radiographic imaging within 180 days after the last dose of first-line [1L]platinum-based therapy) or platinum-refractory ovarian cancer (defined asdisease that has progressed per radiographic imaging while receiving or within 28 days of the last dose of 1L platinum based therapy).
Is a candidate for curative-intent surgery or curative-intent radiotherapy forovarian cancer.
Cohort C:
Has high-grade (FIGO Grade 3 or poorly differentiated) endometrioid carcinomaand nonendometrioid histologies of any type (including serous, clear cell,mixed, carcinosarcoma), and neuroendocrine tumors are not eligible. Uterinemesenchymal tumors such as an endometrial stromal sarcoma, leiomyosarcoma, orother types of pure sarcomas, and adenosarcomas are not eligible.
Is a candidate for curative-intent surgery or curative-intent radiotherapy.
All Cohorts:
Has confirmed or suspected adrenal metastases.
Has known difficulty in tolerating oral medications, unable to swallow orallyadministered medication, or conditions which would impair absorption of oralmedications.
Has any prior history or current condition of adrenal insufficiency.
HIV-infected participants with a history of Kaposi's sarcoma and/orMulticentric Castleman's Disease.
Has received a live or live-attenuated vaccine within 30 days before the firstdose of study intervention. Administration of killed vaccines is allowed.
Has a known additional malignancy that is progressing or has required activetreatment within the past 3 years.
Has known active central nervous system metastases and/or carcinomatousmeningitis.
Has a history of stem cell/solid organ transplant.
Has not adequately recovered from major surgery or has ongoing surgicalcomplications.
Study Design
Connect with a study center
Hospital Aleman ( Site 0301)
Ciudad Autonoma de Buenos Aires, Buenos Aires C1118AAT
ArgentinaActive - Recruiting
Centro Medico Dr. Doreski - Fundación Respirar ( Site 0302)
Buenos Aires, Buenos Aires F.D. C1118AAT
ArgentinaActive - Recruiting
Instituto Alexander Fleming ( Site 0303)
Buenos Aires, Buenos Aires F.D. C1426ANZ
ArgentinaActive - Recruiting
Centro Medico Dr. Doreski - Fundación Respirar ( Site 0302)
Buenos Aires 3435910, Buenos Aires F.D. 3433955 C1118AAT
ArgentinaActive - Recruiting
Instituto Alexander Fleming ( Site 0303)
Buenos Aires 3435910, Buenos Aires F.D. 3433955 C1426ANZ
ArgentinaSite Not Available
Hospital Santa Rita de Cassia ( Site 3104)
Vitória, Espírito Santo 29043-260
BrazilActive - Recruiting
Obras Sociais Irma Dulce ( Site 3112)
Salvador, Estado de Bahia 41680-430
BrazilActive - Recruiting
Obras Sociais Irma Dulce ( Site 3112)
Salvador 3450554, Estado de Bahia 3471168 41680-430
BrazilSite Not Available
Hospital Felicio Rocho ( Site 3105)
Belo Horizonte, Minas Gerais 30110-934
BrazilActive - Recruiting
Hospital Felicio Rocho ( Site 3105)
Belo Horizonte 3470127, Minas Gerais 3457153 30110-934
BrazilSite Not Available
Hospital de Cancer de Pernambuco ( Site 3103)
Recife, Pernambuco 50040-000
BrazilActive - Recruiting
Hospital de Cancer de Pernambuco ( Site 3103)
Recife 3390760, Pernambuco 3392268 50040-000
BrazilSite Not Available
Liga Norte Riograndense Contra o Cancer ( Site 3108)
Natal, Rio Grande do Norte 59062-000
BrazilActive - Recruiting
Liga Norte Riograndense Contra o Cancer ( Site 3108)
Natal 3394023, Rio Grande do Norte 3390290 59062-000
BrazilSite Not Available
Instituto Nacional de Câncer - INCA ( Site 3107)
Rio de Janeiro, 20230-130
BrazilActive - Recruiting
Princess Margaret Cancer Centre ( Site 0202)
Toronto, Ontario M5G 2M9
CanadaActive - Recruiting
Princess Margaret Cancer Centre ( Site 0202)
Toronto 6167865, Ontario 6093943 M5G 2M9
CanadaSite Not Available
Bradfordhill ( Site 3301)
Santiago, Region M. de Santiago 8420383
ChileActive - Recruiting
FALP ( Site 3300)
Santiago, Region M. de Santiago 7500921
ChileActive - Recruiting
Pontificia Universidad Catolica de Chile ( Site 3307)
Santiago, Region M. de Santiago 8330032
ChileActive - Recruiting
FALP ( Site 3300)
Santiago 3871336, Region M. de Santiago 7500921
ChileSite Not Available
Pontificia Universidad Catolica de Chile ( Site 3307)
Santiago 3871336, Region M. de Santiago 8330032
ChileActive - Recruiting
ONCOCENTRO APYS ( Site 3302)
Viña del Mar 3868121, Región de Valparaíso 3868621 2520598
ChileSite Not Available
ONCOCENTRO APYS ( Site 3302)
Viña del Mar, Valparaiso 2520598
ChileActive - Recruiting
Sarawak General Hospital ( Site 0602)
Kuching, Sarawak 93586
MalaysiaActive - Recruiting
Sarawak General Hospital ( Site 0602)
Kuching 1735634, Sarawak 1733038 93586
MalaysiaSite Not Available
Pantai Hospital Kuala Lumpur ( Site 0603)
Kuala Lumpur, 59100
MalaysiaActive - Recruiting
University Malaya Medical Centre ( Site 0601)
Kuala Lumpur, 59100
MalaysiaActive - Recruiting
Pantai Hospital Kuala Lumpur ( Site 0603)
Kuala Lumpur 1735161, 59100
MalaysiaActive - Recruiting
University Malaya Medical Centre ( Site 0601)
Kuala Lumpur 1735161, 59100
MalaysiaSite Not Available
Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 3405)
Concepción, Departamento de Junín 12125
PeruActive - Recruiting
Instituto Regional de Enfermedades Neoplasicas del Centro (IREN CENTRO) ( Site 3405)
Concepción 3942548, Departamento de Junín 3937485 12125
PeruSite Not Available
Clínica San Antonio ( Site 3404)
Trujillo, La Libertad 13008
PeruActive - Recruiting
Clínica San Antonio ( Site 3404)
Trujillo 3691175, La Libertad 3695781 13008
PeruSite Not Available
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3400)
Lima, 15036
PeruActive - Recruiting
Instituto Nacional de Enfermedades Neoplásicas ( Site 3401)
Lima, 15038
PeruActive - Recruiting
IPOR Instituto Peruano de Oncología & Radioterapia ( Site 3400)
Lima 3936456, 15036
PeruSite Not Available
Instituto Nacional de Enfermedades Neoplásicas ( Site 3401)
Lima 3936456, 15038
PeruActive - Recruiting
National Cancer Centre Singapore ( Site 0800)
Singapore, Central Singapore 168583
SingaporeActive - Recruiting
National Cancer Centre Singapore ( Site 0800)
Singapore 1880252, Central Singapore 168583
SingaporeSite Not Available
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2000)
L'Hospitalet de Llobregat, Barcelona 08908
SpainActive - Recruiting
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2000)
L'Hospitalet de Llobregat 3120619, Barcelona 08908
SpainSite Not Available
CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2003)
A Coruña, La Coruna 15006
SpainActive - Recruiting
CHUAC-Complejo Hospitalario Universitario A Coruña ( Site 2003)
A Coruña 3119841, La Coruna 15006
SpainSite Not Available
Clinica Universitaria Navarra - Madrid ( Site 2004)
Madrid, Madrid, Comunidad de 28027
SpainActive - Recruiting
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2002)
Madrid, Madrid, Comunidad de 28034
SpainActive - Recruiting
Clinica Universitaria Navarra - Madrid ( Site 2004)
Madrid 3117735, Madrid, Comunidad de 28027
SpainActive - Recruiting
Hospital Universitario Ramón y Cajal-Medical Oncology ( Site 2002)
Madrid 3117735, Madrid, Comunidad de 28034
SpainSite Not Available
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2001)
Madrid, 28223
SpainActive - Recruiting
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2001)
Madrid 3117735, 28223
SpainActive - Recruiting
Taichung Veterans General Hospital ( Site 1004)
Taichung, 407
TaiwanActive - Recruiting
Taichung Veterans General Hospital ( Site 1004)
Taichung 1668399, 407
TaiwanSite Not Available
National Cheng Kung University Hospital ( Site 1003)
Tainan, 704
TaiwanActive - Recruiting
National Cheng Kung University Hospital ( Site 1003)
Tainan 1668355, 704
TaiwanSite Not Available
National Cheng Kung University Hospital ( Site 1003)
Tainan City 1668355, 704
TaiwanSite Not Available
Mackay Memorial Hospital ( Site 1002)
Taipei, 10449
TaiwanActive - Recruiting
Mackay Memorial Hospital ( Site 1002)
Taipei 1668341, 10449
TaiwanSite Not Available
Chulalongkorn Hospital ( Site 1114)
Bangkok, Bangkok 10330
ThailandActive - Recruiting
Faculty of Medicine Siriraj Hospital ( Site 1111)
Bangkok, Bangkok 10700
ThailandActive - Recruiting
Chulalongkorn Hospital ( Site 1114)
Bangkok 1609350, Bangkok 1609348 10330
ThailandActive - Recruiting
Faculty of Medicine Siriraj Hospital ( Site 1111)
Bangkok 1609350, Bangkok 1609348 10700
ThailandSite Not Available
Songklanagarind Hospital ( Site 1113)
Songkhla, 90110
ThailandActive - Recruiting
Songklanagarind Hospital ( Site 1113)
Songkhla 1606147, 90110
ThailandSite Not Available
Baskent Universitesi Adana Dr. Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2201)
Adana, 01240
Turkey (Türkiye)Active - Recruiting
Hacettepe Universitesi ( Site 2200)
Ankara, 06230
Turkey (Türkiye)Active - Recruiting
Hacettepe Universitesi ( Site 2200)
Ankara 323786, 06230
Turkey (Türkiye)Site Not Available
Trakya Üniversitesi Eğitim Araştırma Hastanesi ( Site 2204)
Edirne, 22030
Turkey (Türkiye)Active - Recruiting
Trakya Üniversitesi Eğitim Araştırma Hastanesi ( Site 2204)
Edirne 747712, 22030
Turkey (Türkiye)Site Not Available
Istanbul Universitesi Cerrahpasa ( Site 2203)
Istanbul, 34098
Turkey (Türkiye)Active - Recruiting
Koc University, School of Medicine ( Site 2202)
Istanbul, 34450
Turkey (Türkiye)Active - Recruiting
University Hospitals Sussex NHS Foundation Trust ( Site 2301)
East Sussex, Brighton And Hove BN2 1ES
United KingdomActive - Recruiting
The Royal Cornwall Hospital ( Site 2306)
Truro, Cornwall TR1 3LJ
United KingdomActive - Recruiting
The Royal Cornwall Hospital ( Site 2306)
Truro 2635412, Cornwall TR1 3LJ
United KingdomSite Not Available
Guy's & St Thomas' NHS Foundation Trust ( Site 2309)
London, London, City of SE1 9RT
United KingdomActive - Recruiting
St Bartholomew's Hospital ( Site 2302)
London, London, City of EC1A 7BE
United KingdomActive - Recruiting
University College Hospital London ( Site 2303)
London, London, City of NW1 2PG
United KingdomActive - Recruiting
Guy's & St Thomas' NHS Foundation Trust ( Site 2309)
London 2643743, London, City of SE1 9RT
United KingdomSite Not Available
St Bartholomew's Hospital ( Site 2302)
London 2643743, London, City of EC1A 7BE
United KingdomActive - Recruiting
University College Hospital London ( Site 2303)
London 2643743, London, City of NW1 2PG
United KingdomActive - Recruiting
Western General Hospital ( Site 2307)
Edinburgh, Midlothian EH4 2XU
United KingdomActive - Recruiting
Western General Hospital ( Site 2307)
Edinburgh 2650225, Midlothian EH4 2XU
United KingdomSite Not Available
Queen Elizabeth Hospital ( Site 2305)
Birmingham, B15 2GW
United KingdomActive - Recruiting
Queen Elizabeth Hospital ( Site 2305)
Birmingham 2655603, B15 2GW
United KingdomSite Not Available
The Christie NHS Foundation Trust ( Site 2300)
Manchester, M20 4BX
United KingdomActive - Recruiting
The Christie NHS Foundation Trust ( Site 2300)
Manchester 2643123, M20 4BX
United KingdomSite Not Available
Alaska Womens Cancer Care ( Site 0037)
Anchorage, Alaska 99508
United StatesActive - Recruiting
Alaska Womens Cancer Care ( Site 0037)
Anchorage 5879400, Alaska 5879092 99508
United StatesSite Not Available
Mount Sinai Cancer Center ( Site 0009)
Miami Beach, Florida 33140
United StatesActive - Recruiting
Mount Sinai Cancer Center ( Site 0009)
Miami Beach 4164143, Florida 4155751 33140
United StatesSite Not Available
TRIALS 365 ( Site 0022)
Shreveport, Louisiana 71103
United StatesActive - Recruiting
TRIALS 365 ( Site 0022)
Shreveport 4341513, Louisiana 4331987 71103
United StatesSite Not Available
Mary Lanning Healthcare ( Site 0019)
Hastings, Nebraska 68901
United StatesActive - Recruiting
Mary Lanning Healthcare ( Site 0019)
Hastings 5069802, Nebraska 5073708 68901
United StatesSite Not Available
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0021)
Hackensack, New Jersey 07601
United StatesActive - Recruiting
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0021)
Hackensack 5098706, New Jersey 5101760 07601
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center ( Site 0002)
New York, New York 10065
United StatesActive - Recruiting
The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 0008)
Columbus, Ohio 43210
United StatesActive - Recruiting
Baylor College of Medicine Medical Center ( Site 0004)
Houston, Texas 77030
United StatesActive - Recruiting
Mays Cancer Center ( Site 0039)
San Antonio, Texas 78229
United StatesActive - Recruiting
Baylor College of Medicine Medical Center ( Site 0004)
Houston 4699066, Texas 4736286 77030
United StatesSite Not Available
Mays Cancer Center ( Site 0039)
San Antonio 4726206, Texas 4736286 78229
United StatesSite Not Available

Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.