stop_circleTerminated/Withdrawn
Breast Neoplasms
Bayer Identifier:
16298
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study of radium-223 dichloride versus placebo and hormonal treatment as background therapy in subjects with bone predominant HER2 (Human epidermal growth factor receptor 2) negative hormone receptor positive metastatic breast cancer
Trial purpose
The objective of this study was to assess efficacy and safety of radium-223 dichloride in subjects with human epidermal growth factor receptor 2 negative (HER2 negative) hormone receptor positive breast cancer with bone metastases treated with hormonal treatment background therapy
Key Participants Requirements
Sex
FemaleAge
18 - N/ATrial summary
Enrollment Goal
99Trial Dates
March 2015 - August 2019Phase
Phase 2Could I Receive a placebo
YesProducts
Xofigo (Radium-223 dichloride, BAY88-8223)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Kfar Saba, 4428164, Israel | |
Withdrawn | Petach Tikva, 4941492, Israel | |
Completed | Zerifin, 7030000, Israel | |
Completed | Haifa, 3109601, Israel | |
Withdrawn | Rehovot, 7610001, Israel | |
Completed | Jerusalem, 9112001, Israel | |
Withdrawn | Beer Sheva, 8410101, Israel | |
Completed | Tel Aviv, 64239, Israel | |
Completed | Afula, 1834111, Israel | |
Withdrawn | Holon, 5822012, Israel | |
Completed | Ramat Gan, 5262000, Israel | |
Completed | Jerusalem, 9103102, Israel | |
Completed | Linz, 4020, Austria | |
Withdrawn | Leoben, 8700, Austria | |
Withdrawn | Linz, 4010, Austria | |
Completed | Innsbruck, 6020, Austria | |
Completed | Sheffield, S10 2SJ, United Kingdom | |
Completed | Nottingham, NG5 1PB, United Kingdom | |
Withdrawn | Philadelphia, 19104, United States | |
Withdrawn | Rochester, 55905, United States | |
Completed | Ann Arbor, 48109, United States | |
Withdrawn | Madrid, 28007, Spain | |
Completed | Madrid, 28033, Spain | |
Withdrawn | Palma de Mallorca, 07120, Spain | |
Terminated | Sevilla, 41071, Spain | |
Withdrawn | Madrid, 28046, Spain | |
Withdrawn | Pamplona, 31008, Spain | |
Completed | Barcelona, 08025, Spain | |
Completed | L'Hospitalet de Llobregat, 08907, Spain | |
Withdrawn | Padova, 35128, Italy | |
Withdrawn | Roma, 00189, Italy | |
Withdrawn | Palermo, 90146, Italy | |
Withdrawn | Bari, 70124, Italy | |
Withdrawn | Modena, 41124, Italy | |
Withdrawn | Reggio Emilia, 42123, Italy | |
Withdrawn | Genova, 16128, Italy | |
Withdrawn | Verona, 37024, Italy | |
Withdrawn | Milano, 20133, Italy | |
Completed | Cork, Ireland | |
Withdrawn | Forlì Cesena, 47014, Italy | |
Completed | Gdynia, 81-519, Poland | |
Withdrawn | Gdansk, 80-952, Poland | |
Withdrawn | Gliwice, 44-101, Poland | |
Withdrawn | Krakow, 31-051, Poland | |
Withdrawn | Lublin, 20-090, Poland | |
Completed | Bialystok, 15-027, Poland | |
Completed | Helsinki, 00290, Finland | |
Withdrawn | Vaasa, 65130, Finland | |
Completed | Tampere, FIN-33520, Finland | |
Withdrawn | Turku, FIN-20521, Finland | |
Withdrawn | Mainz, 55131, Germany | |
Withdrawn | Aachen, 52074, Germany | |
Terminated | Essen, 45147, Germany | |
Withdrawn | Köln, 50935, Germany | |
Completed | Málaga, 29010, Spain | |
Withdrawn | Barcelona, 08035, Spain | |
Terminated | Madrid, 28041, Spain | |
Withdrawn | Madrid, 28050, Spain | |
Completed | Madrid, 28040, Spain | |
Completed | Barcelona, 08036, Spain | |
Terminated | Zaragoza, 50009, Spain | |
Completed | Warszawa, 02-781, Poland | |
Withdrawn | Watertown, 57201, United States | |
Withdrawn | Spokane, 99208-1129, United States | |
Completed | Cedar Rapids, 52403, United States | |
Withdrawn | Long Beach, 90813, United States | |
Withdrawn | Detroit, 48202, United States | |
Withdrawn | Omaha, 68130, United States | |
Withdrawn | Ft. Lauderdale, 33316, United States | |
Withdrawn | Plantation, 33324, United States | |
Completed | Aurora, 80045, United States | |
Terminated | Pittsburgh, 15213-3180, United States | |
Completed | Pontiac, 48341, United States | |
Completed | Annapolis, 21401, United States | |
Completed | New Haven, 06520, United States | |
Withdrawn | Cleveland, 44195, United States | |
Completed | La Jolla, 92093, United States | |
Completed | St. Louis, 63110, United States | |
Withdrawn | Shatin, Hong Kong | |
Withdrawn | Hong Kong, Hong Kong | |
Completed | Hong kong, Hong Kong | |
Withdrawn | Hong Kong, Hong Kong | |
Terminated | København, 2100, Denmark | |
Terminated | Herlev, 2730, Denmark | |
Withdrawn | Odense C, 5000, Denmark | |
Completed | Seoul, 03080, Korea, Republic Of | |
Completed | Seoul, 05505, Korea, Republic Of | |
Withdrawn | Seoul, 06591, Korea, Republic Of | |
Completed | Seoul, 03722, Korea, Republic Of | |
Completed | Busan, 49241, Korea, Republic Of | |
Completed | Incheon, Korea, Republic Of | |
Withdrawn | Salamanca, 37007, Spain | |
Withdrawn | Monza-Brianza, 20900, Italy | |
Withdrawn | Roma, 00161, Italy | |
Withdrawn | Lugo, 27003, Spain | |
Withdrawn | Viganello, 6962, Switzerland | |
Completed | Tübingen, 72076, Germany | |
Completed | Bonn, 53105, Germany | |
Completed | A Coruña, 15009, Spain | |
Completed | London, N6A 4L6, Canada | |
Withdrawn | Montreal, H3T 1E2, Canada | |
Completed | Toronto, M5G 2M9, Canada | |
Withdrawn | Ottawa, K1H 8L6, Canada | |
Terminated | Winnipeg, R3E 0V9, Canada | |
Withdrawn | Göteborg, 413 45, Sweden | |
Withdrawn | Växjö, 35185, Sweden | |
Withdrawn | Bodø, 8092, Norway | |
Completed | Oslo, 0424, Norway | |
Withdrawn | Omaha, 68130, United States | |
Withdrawn | Newark, 07103, United States | |
Withdrawn | Cleveland, 44109-1998, United States | |
Completed | NIEUWEGEIN, 3435 CM, Netherlands | |
Withdrawn | HOOFDDORP, 2134 TM, Netherlands | |
Withdrawn | HEERLEN, 6401 CX, Netherlands | |
Withdrawn | DORDRECHT, 3318 AT, Netherlands | |
Withdrawn | Yuma, 85364, United States | |
Withdrawn | Milano, 20132, Italy | |
Withdrawn | MONTPELLIER CEDEX, 34298, France | |
Withdrawn | CLERMONT FERRAND CEDEX 1, 63011, France | |
Withdrawn | LA ROCHE SUR YON cedex, 85925, France | |
Withdrawn | DIJON, 21079, France | |
Completed | SAINT CLOUD, 92210, France | |
Withdrawn | GRENOBLE, 38043, France | |
Withdrawn | RENNES CEDEX, 35062, France | |
Withdrawn | VANDOEUVRE LES NANCY, 54000, France | |
Completed | Taunton, TA1 5DA, United Kingdom | |
Withdrawn | Bristol, BS2 8ED, United Kingdom | |
Withdrawn | Belfast, BT9 7AE, United Kingdom | |
Withdrawn | Guildford, GU27XX, United Kingdom | |
Terminated (Halted Prematurely) | Merseyside, CH63 4JY, United Kingdom | |
Completed | Northwood, HA6 2RN, United Kingdom | |
Withdrawn | Romford, RM7 0AG, United Kingdom | |
Withdrawn | Coventry, CV2 2DX, United Kingdom | |
Completed | Houston, 77230, United States | |
Withdrawn | Taoyuan, 33305, Taiwan | |
Withdrawn | Taipei, Taiwan | |
Withdrawn | Kaoshiung, 81346, Taiwan | |
Completed | Taipei, 11217, Taiwan | |
Withdrawn | Singapore, 217562, Singapore | |
Completed | Singapore, 119074, Singapore | |
Withdrawn | Singapore, 258499, Singapore | |
Completed | Cottingham, HU16 5JQ, United Kingdom | |
Withdrawn | Taiwan, Taiwan | |
Withdrawn | CAEN CEDEX 5, 14076, France | |
Withdrawn | Bologna, 40138, Italy | |
Terminated | Aarau, 5001, Switzerland | |
Completed | Dublin, 7, Ireland | |
Withdrawn | Galway, Ireland | |
Completed | Newmarket, L3Y 2P9, Canada | |
Withdrawn | Chomutov, 430 12, Czechia | |
Withdrawn | Olomouc, 775 20, Czechia | |
Completed | Ostrava, 708 52, Czechia | |
Completed | Praha 2, 12808, Czechia | |
Completed | PLYMOUTH, PL6 8DH, United Kingdom | |
Withdrawn | München, 81675, Germany | |
Withdrawn | Bismarck, 58501, United States | |
Withdrawn | NIJMEGEN, 6500 HB, Netherlands | |
Withdrawn | HAARLEM, 2035 RC, Netherlands | |
Withdrawn | Dublin 6, Ireland | |
Withdrawn | Beijing, 100730, China | |
Withdrawn | Guangzhou, 510060, China | |
Withdrawn | Guangzhou, 510080, China | |
Withdrawn | Shanghai, China | |
Withdrawn | Beijing, 100020, China | |
Withdrawn | Lake Success, 11042, United States | |
Withdrawn | Ashland, 41101, United States | |
Completed | Bakersfield, 93309, United States | |
Completed | Daegu, 42601, Korea, Republic Of | |
Withdrawn | Suwon-si, 442-723, Korea, Republic Of | |
Withdrawn | Sevilla, 41013, Spain | |
Completed | ZWOLLE, 8025 AB, Netherlands | |
Withdrawn | DEN HAAG, 2545 CH, Netherlands | |
Withdrawn | AMERSFOORT, 3818 TZ, Netherlands | |
Withdrawn | CHAMBERY CEDEX, 73011, France | |
Withdrawn | BRON, 69677, France | |
Completed | ANGERS CEDEX, 49055, France |
Primary Outcome
- Symptomatic skeletal event free survival (SSE-FS)Time from date of randomization to occurrence of one of the following, whichever happened earlier: 1) an on study SSE, which was defined as the use of external beam radiotherapy (EBRT) to relieve skeletal symptoms, the occurrence of new symptomatic pathological bone fractures (vertebral or nonvertebral), the occurrence of spinal cord compression, a tumor related orthopedic surgical intervention; or 2) death from any causedate_rangeTime Frame:Up to approximately 51 months
Secondary Outcome
- Overall survivalTime from randomization to death from any causedate_rangeTime Frame:Up to approximately 51 months
- Time to opiate use for cancer painInterval from the date of randomization to the date of opiate usedate_rangeTime Frame:Up to approximately 51 months
- Time to pain progressionTime from randomization to the first date a participants (only in participants with baseline WPS ≤8) experiences pain progression based on worst pain score (WPS) ranging from 0 to 10 and analgesic use. Pain progression is defined as an increase of 2 or more points in the “Worst pain in 24 hours” score from baseline observed at 2 consecutive evaluations ≥4 weeks apart or an increase in pain management (IPM) with respect to baseline, whichever occurs firstdate_rangeTime Frame:Up to approximately 51 months
- Pain Improvement RateThe percentage of participants (baseline WPS>=2) with confirmed pain improvement at any time point. Confirmed pain improvement is defined as a 2 point decrease in worst pain score (WPS) from baseline over 2 consecutive assessment periods conducted at least 4 weeks apartdate_rangeTime Frame:Up to approximately 51 months
- Time to cytotoxic chemotherapyTime from the date of randomization to the date of the first cytotoxic chemotherapydate_rangeTime Frame:Up to approximately 51 months
- Radiological progression-free survival (rPFS)Time from the date of randomization to the date of first radiological progression or death (if death occurs before progression)date_rangeTime Frame:Up to approximately 51 months
- Number of participants with treatment-emergent adverse eventsAny event arising or worsening after the start of study drug administration until 30 days after the last study medication intakedate_rangeTime Frame:Up to approximately 7 months
- Number of participants with post-treatment adverse events including additional malignancies and chemotherapy related adverse eventsAEs related to the study drug, all occurrences of additional malignancies, febrile neutropenia and hemorrhage in subjects receiving chemotherapy, bone fractures and bone associated events (regardless of severity and relationship to study drug), and some symptoms needed for the characterization of an symptomatic skeletal eventdate_rangeTime Frame:From 30 days after the last dose of study treatment until the end of study, assessed up to approximately 44 months
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2