| 1 |
NCT03471572 |
Recruiting |
Study to Assess Prevalence of BRCA1 and BRCA2 Mutation Among Ovarian, Primary Peritoneal and Fallopian Tube Cancer Patients in India |
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- BRCA1 or BRCA2 mutation positive status
- Association between histopathological type and BRCA 1/BRCA 2 mutation positive status
|
240 |
Female |
18 Years to 130 Years (Adult, Senior) |
NCT03471572 |
D0818R00001 |
BRCA |
March 22, 2018 |
December 31, 2018 |
December 31, 2018 |
March 20, 2018 |
April 19, 2018 |
|
- Research Site
Hyderabad, India - Research Site
Kolkata, India - Research Site
Mumbai, India
|
| 2 |
NCT02341118 |
Recruiting |
Capturing BRCA1/2 Mutational Status in Women With High Grade Serous Ovarian Cancer and Impact on Clinical Outcome. |
|
- Genetic: BRCA genetic data
|
Observational |
|
- University Health Network, Toronto
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- genomic profiling for BRCA1 and BRCA2 mutational status in patients' with high grade serous ovarian cancer.
|
1000 |
Female |
18 Years and older (Adult, Senior) |
NCT02341118 |
BRCA Screening |
|
May 2014 |
May 2020 |
May 2020 |
January 19, 2015 |
September 20, 2017 |
|
- Princess Margaret Cancer Centre
Toronto, Ontario, Canada
|
| 3 |
NCT03396341 |
Recruiting |
Responses to Genetic Risk Modifier Testing Among Women With BRCA1/2 Mutations |
|
- Other: Salvia sample
- Behavioral: Questionnaires
|
Observational |
|
- Memorial Sloan Kettering Cancer Center
- Phenogen Sciences
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- number of patients that opt for preventive mastectomy or to pursue surveillance
|
195 |
Female |
25 Years and older (Adult, Senior) |
NCT03396341 |
17-489 |
|
January 4, 2018 |
January 2021 |
January 2021 |
January 10, 2018 |
January 10, 2018 |
|
- Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, United States - Memorial Sloan Kettering Commack
Commack, New York, United States - Memoral Sloan Kettering Westchester
Harrison, New York, United States - (and 2 more...)
|
| 4 |
NCT03495609 |
Recruiting
New |
Use of Recombinant hCG to Prevent Breast Cancer in BRCA1 and BRCA2 Carriers |
- hCG
- BRCA1 Mutation
- BRCA2 Mutation
|
|
Interventional |
Phase 4 |
- University Hospital, Ghent
- Fox Chase Cancer Center
- Ziekenhuis Oost-Limburg
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Does Ovitrelle result in early prevention of breast cancer in BRCA1 and BRCA2 carriers?
|
35 |
Female |
18 Years to 30 Years (Adult) |
NCT03495609 |
2015-001720-36 |
|
February 17, 2016 |
December 2020 |
July 2021 |
April 12, 2018 |
April 12, 2018 |
|
- Ghent University Hospital
Ghent, East-Flanders, Belgium
|
| 5 |
NCT03351803 |
Recruiting |
BRCA Founder OutReach (BFOR) Study |
- BRCA1 Mutation
- BRCA2 Mutation
|
- Other: BFOR Digital Health solution/Web Portal
|
Observational |
|
- Memorial Sloan Kettering Cancer Center
- Cedars-Sinai Medical Center
- Dana-Farber Cancer Institute
- (and 6 more...)
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Proportion of individuals receiving a standardized program of pretest education who then proceed to genetic testing
- Proportions of individuals who choose to receive the results through their primary care providers or through the study-provided expert staff
- Psychosocial impact of genetic population screening utilizing a digital health solution
- (and 2 more...)
|
4000 |
All |
25 Years and older (Adult, Senior) |
NCT03351803 |
17-568 |
BFOR |
November 10, 2017 |
November 10, 2018 |
November 10, 2018 |
November 24, 2017 |
March 29, 2018 |
|
- Cedars-Sinai Medical Center
Los Angeles, California, United States - Dana Farber Cancer Institute
Boston, Massachusetts, United States - Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States - (and 2 more...)
|
| 6 |
NCT02154672 |
Recruiting |
Prostate Cancer Screening in Men With Germline BRCA2 Mutations |
|
|
Observational |
|
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Incidence of Prostate Cancer in BRCA2 Mutation Carriers
|
100 |
Male |
30 Years to 90 Years (Adult, Senior) |
NCT02154672 |
1402013376 |
|
May 2014 |
May 2018 |
May 2018 |
June 3, 2014 |
January 9, 2018 |
|
- Yale University
New Haven, Connecticut, United States
|
| 7 |
NCT02321228 |
Recruiting |
Early Salpingectomy (Tubectomy) With Delayed Oophorectomy in BRCA1/2 Gene Mutation Carriers |
- BRCA1 Gene Mutation
- BRCA2 Gene Mutation
- Ovarian Cancer
|
- Procedure: Salpingectomy with delayed oophorectomy
- Procedure: Risk-reducing salpingo-oophorectomy
|
Interventional |
Not Applicable |
- University Medical Center Nijmegen
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Menopause-related quality of life
- General quality of life
- Quality of life related items
- (and 7 more...)
|
510 |
Female |
25 Years to 45 Years (Adult) |
NCT02321228 |
NL50048.091.14 |
TUBA |
January 2015 |
January 2025 |
January 2035 |
December 22, 2014 |
August 23, 2016 |
|
- Maastricht University Medical Center
Maastricht, Limburg, Netherlands - Catharina Hospital
Eindhoven, Noord-Brabant, Netherlands - Elisabeth-TweeSteden Hospital
Tilburg, Noord-Brabant, Netherlands - (and 7 more...)
|
| 8 |
NCT03296826 |
Recruiting |
Prospective Cohort Study of Variant Carriers With BRCA1 or BRCA2 |
- BRCA1 and/or BRCA2 Variant Carriers
- Ovarian Carcinoma
- Fallopian Tube Carcinoma
- Peritoneal Carcinoma
|
|
Observational |
|
- Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan
- Keio University
- Japanese Gynecologic Oncology Group (JGOG)
|
Other |
- Observational Model: Cohort
- Time Perspective: Retrospective
|
- Occurrence of ovarian, fallopian tube, and peritoneal carcinoma
- Development of ovarian, fallopian tube, and peritoneal cancers, and the detection rate of occult cancer, based on evaluations of histopathological samples taken post-RSSO.
- Death from any cause
- (and 4 more...)
|
600 |
Female |
20 Years and older (Adult, Senior) |
NCT03296826 |
JGOG3024
UMIN000028740 |
|
November 8, 2017 |
March 31, 2032 |
March 31, 2032 |
September 28, 2017 |
November 24, 2017 |
|
- Keio University
Tokyo, Japan
|
| 9 |
NCT02474264 |
Recruiting |
The Link Between BRCA Mutation and Endothelial Function |
- BRCA1 Gene Mutation
- BRCA2 Gene Mutation
|
- Other: Endothelial function assessment
- Other: Cardiovascular biomarkers
- Other: Endothelial cells
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Screening
|
- reactive hyperemia index will be assessed using the Endo-PAT2000
- The level of high sensitivity troponin (hsTn) - a cardiovascular risk biomarker will be measured
- The level of C-reactive protein - a cardiovascular risk biomarker will be measured
- (and 4 more...)
|
82 |
Male |
18 Years to 70 Years (Adult, Senior) |
NCT02474264 |
0594-14-RMC |
|
February 2015 |
July 2018 |
November 2018 |
June 17, 2015 |
July 18, 2017 |
|
- Rabin Medical Center, Beilinson Hospital
Petah Tikva, Israel
|
| 10 |
NCT03066856 |
Recruiting |
Dietary Intervention and BRCA Penetrance |
- Dietary Modification
- BRCA1 Mutation
- BRCA2 Mutation
- Breast Cancer
|
- Other: Dietary intervention
|
Interventional |
Not Applicable |
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
- Istituto Oncologico di Bari
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Reduction of serum levels of IGF-I (ng/mL) (intervention trial).
- Case-control analysis: comparison of the affected versus the unaffected BRCA mutation carriers for the baseline IRm levels baseline serum levels of IGF-I and IRm.
- Survival analysis: evaluation of the association between IGF-I and IGF-I changes and subsequent BC incidence and BC prognosis (BC incidence for unaffected women and ipsilateral or contralateral BC and BC recurrences for affected women).
|
600 |
Female |
18 Years to 70 Years (Adult, Senior) |
NCT03066856 |
106/13 |
|
December 1, 2015 |
December 31, 2018 |
December 31, 2018 |
March 1, 2017 |
March 1, 2017 |
|
- Fondazione IRCCS Istituto Nazionale dei Tumori
Milano, Italy
|
| 11 |
NCT01990521 |
Recruiting |
Prostate Screening Study Using MRI in BRCA Carriers |
|
- Procedure: MS3TMRI / TRUS Guided Biopsy
- Device: MS3TMRI / TRUS Guided Biopsy
|
Interventional |
Not Applicable |
- Toronto Sunnybrook Regional Cancer Centre
- Sunnybrook Health Sciences Centre
- Women's College Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Prostate MRI in BRCA carriers
- Prostate cancer in BRCA carriers
|
60 |
Male |
50 Years and older (Adult, Senior) |
NCT01990521 |
500-2013 |
|
January 2014 |
January 2019 |
January 2020 |
November 21, 2013 |
April 25, 2017 |
|
- Sunnybrook Odette Cancer Centre
Toronto, Ontario, Canada
|
| 12 |
NCT02462460 |
Recruiting |
Rapid Pancreatic and Ovarian Screening MR Imaging With Motion Corrected T1, T2, and Advanced Diffusion Weighted Imaging for Patients With BRCA Mutation Who Undergo Screening Breast MRI |
- Screening Breast MRI in Patients Who Are BRCA Mutation Carriers
|
- Device: MRI
- Behavioral: Optional Screening Questionnaire
|
Observational |
|
- Memorial Sloan Kettering Cancer Center
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- define optimized acquisition
|
60 |
Female |
30 Years and older (Adult, Senior) |
NCT02462460 |
15-120 |
|
June 2015 |
June 2018 |
June 2018 |
June 4, 2015 |
August 18, 2017 |
|
- Memorial Sloan Kettering Cancer Center
New York, New York, United States
|
| 13 |
NCT01898312 |
Recruiting |
BRCA1/2 and Effect of Mifepristone on the Breast |
- Women With Mutations in the Breast Cancer Susceptibility Genes BRCA1,2
|
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- epithelial cell proliferation in breast tissue
- Vital signs and safety lab analysis
- Side effects and Adverse Events
- (and 3 more...)
|
45 |
Female |
18 Years and older (Adult, Senior) |
NCT01898312 |
2012-003703-35 |
|
September 2013 |
December 2018 |
December 2018 |
July 12, 2013 |
March 6, 2018 |
|
- Department of Woman and Child Health Karolinska University Hospital
Stockholm, Sweden
|
| 14 |
NCT02984423 |
Recruiting |
FLABRA: Frontline Approach for BRCA Testing in OC Treatment naïve Population. A LATIN AMERICA Epidemiologic Study |
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Prevalence of BRCA 1 and BRCA 2 mutations in newly diagnosed ovarian cancer patients from Latinoamerican population
- Prevalence of somatic and germline BRCA 1 and 2 mutations across Latinamerican population
- Counselling approach in ovarian cancer across Latinamerican countries
|
480 |
Female |
Child, Adult, Senior |
NCT02984423 |
D0817R00002 |
FLABRA |
December 27, 2016 |
March 1, 2019 |
March 30, 2019 |
December 7, 2016 |
April 13, 2018 |
|
- Research Site
Buenos Aires, Argentina - Research Site
Buenos Aires, Argentina - Research Site
Cordoba, Argentina - (and 33 more...)
|
| 15 |
NCT02225015 |
Recruiting |
Cancer Prevention in Women With a BRCA Mutation |
- BRCA1 Gene Mutation
- BRCA2 Gene Mutation
- Breast Cancer
- Ovarian Cancer
|
- Behavioral: Follow-up Telephone Genetic Counselling
|
Interventional |
Phase 1 |
- Women's College Hospital
- Canadian Institutes of Health Research (CIHR)
- London Health Sciences Centre
- (and 2 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Supportive Care
|
- Efficacy of FTGC session
- Emotional and cognitive outcomes of intervention
|
300 |
Female |
35 Years to 70 Years (Adult, Senior) |
NCT02225015 |
324638 |
|
January 2015 |
June 2018 |
June 2019 |
August 25, 2014 |
June 9, 2016 |
|
- London Regional Cancer Centre
London, Ontario, Canada - Women's College Hospital
Toronto, Ontario, Canada - Princess Margaret Hospital
Toronto, Ontario, Canada
|
| 16 |
NCT02197000 |
Recruiting |
A Nutritional Intervention to Decrease Breast Density Among Female BRCA (BReast CAncer Susceptibility Gene) Carriers |
- BRCA1 Gene Mutation
- BRCA2 Gene Mutation
|
- Dietary Supplement: DIM-Avail 100mg
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Changes in breast density compared to baseline
- Estrogen profile
- The Estronex Profile
- Quality of life
|
36 |
Female |
18 Years to 70 Years (Adult, Senior) |
NCT02197000 |
0117-14-RMC |
|
September 2014 |
September 2018 |
September 2018 |
July 22, 2014 |
October 17, 2017 |
|
- Rabin Medical Center, Beilinson Hospital
Petah-Tikva, Israel
|
| 17 |
NCT02478892 |
Recruiting |
Screening for PDAC in BRCA1/2 Patients |
|
- Device: prophylactic endoscopic ultrasound
|
Observational |
|
- Abramson Cancer Center of the University of Pennsylvania
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- identifying pancreatic neoplastic lesions in patients with BRCA1/2 mutations and other less common, but related mutations (ATM, PALB2) as well as mutations identified in the future.
|
200 |
All |
18 Years and older (Adult, Senior) |
NCT02478892 |
UPCC 26214 |
|
May 2015 |
May 2020 |
|
June 23, 2015 |
April 11, 2016 |
|
- Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
|
| 18 |
NCT03025035 |
Recruiting |
Pembrolizumab in Advanced BRCA-mutated Breast Cancer |
|
|
Interventional |
Phase 2 |
- Monica Mita
- Merck Sharp & Dohme Corp.
- Cedars-Sinai Medical Center
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall response rate (ORR) per RECIST1.1
- Progression free survival (PFS), per RECIST 1.1
- Overall survival (OS)
- (and 2 more...)
|
20 |
All |
18 Years and older (Adult, Senior) |
NCT03025035 |
IIT2015-18-Mita-MK3475 |
|
September 10, 2017 |
January 30, 2020 |
January 30, 2023 |
January 19, 2017 |
February 16, 2018 |
|
- Cedars-Sinai Medical Center
Los Angeles, California, United States
|
| 19 |
NCT02282020 |
Recruiting |
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 |
- Relapsed Ovarian Cancer, BRCA Mutation, Platinum Sensitivity
|
- Drug: OLAPARIB
- Drug: Single agent chemotherapy
|
Interventional |
Phase 3 |
- AstraZeneca
- Myriad Genetic Laboratories, Inc.
- Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective Response Rate (ORR)
- Overall Survival (OS)
- PFS 2 - time from randomisation to second progression
- (and 8 more...)
|
250 |
All |
18 Years and older (Adult, Senior) |
NCT02282020 |
D0816C00010 |
SOLO3 |
February 6, 2015 |
January 1, 2019 |
January 1, 2021 |
November 4, 2014 |
April 24, 2018 |
|
- Research Site
Birmingham, Alabama, United States - Research Site
Mobile, Alabama, United States - Research Site
Tucson, Arizona, United States - (and 117 more...)
|
| 20 |
NCT00261456 |
Recruiting |
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer |
- Prostate Cancer in BRCA1 and BRCA2 Carriers
|
- Behavioral: PSA test
- Procedure: Prostate Biopsy
|
Observational |
|
- Institute of Cancer Research, United Kingdom
- Cancer Research UK
- Royal Marsden NHS Foundation Trust
- Ronald and Rita McAulay Foundation
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
|
1700 |
Male |
40 Years to 69 Years (Adult, Senior) |
NCT00261456 |
05/MRE07/25
CCR2598 |
|
October 2005 |
December 2019 |
December 2021 |
December 5, 2005 |
September 14, 2017 |
|
- Cancer Genetics Unit, Royal Marsden Hospital
Sutton, Surrey, United Kingdom
|
| 21 |
NCT03082976 |
Recruiting |
Prevalence of BRCA1 and BRCA2 Mutations in Ovarian Cancer Patients in the Gulf Region |
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Prevalence of somatic BRCA mutations among ovarian cancer patients
- Associations or correspondence in prevalence between genetic alterations
- Describe epidemiological characteristics
- (and 2 more...)
|
120 |
Female |
18 Years and older (Adult, Senior) |
NCT03082976 |
D133FR00118 |
PREDICT |
July 16, 2017 |
September 30, 2018 |
September 30, 2018 |
March 17, 2017 |
March 29, 2018 |
|
- Research Site
Kuwait, Kuwait - Research Site
Muscat, Oman - Research Site
Doha, Qatar - Research Site
Abu Dhabi, United Arab Emirates
|
| 22 |
NCT03470402 |
Recruiting |
Decision Support for BRCA Testing in Ethnically Diverse Women |
- Breast Cancer
- BRCA1 Mutation
- BRCA2 Mutation
- Ovarian Cancer
|
- Other: RealRisks
- Other: BNAV
- Other: iNYP
- (and 2 more...)
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Uptake rate of genetic counseling by 6 months
- Change in patient decision conflict scale score
- Shared Decision Making (Likert Scale Score)
- Patient Informed Choice
|
275 |
All |
21 Years and older (Adult, Senior) |
NCT03470402 |
AAAR3676 |
|
December 13, 2017 |
January 2020 |
January 2020 |
March 20, 2018 |
March 20, 2018 |
|
- Columbia University Medical Center
New York, New York, United States
|
| 23 |
NCT02826512 |
Not yet recruiting |
A Feasibility Study of Niraparib for Advanced, BRCA1-like, HER2-negative Breast Cancer Patients |
|
|
Interventional |
Phase 2 |
- The Netherlands Cancer Institute
- Tesaro, Inc.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression free survival
- Objective response rate
- Duration of response
- Toxicity; Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.03
|
39 |
All |
18 Years and older (Adult, Senior) |
NCT02826512 |
M14ABC |
|
October 2017 |
August 2020 |
August 2022 |
July 11, 2016 |
September 14, 2017 |
|
- Antoni van Leeuwenhoek
Amsterdam, Netherlands - Erasmus Medical Center Cancer Institute
Rotterdam, Netherlands
|
| 24 |
NCT01989546 |
Recruiting |
Pilot Trial of BMN 673, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Deleterious BRCA Mutations |
- Advanced Ovarian Cancer
- Primary Peritoneal Cancer
- Advanced Breast Cancer
- Advanced Solid Tumors
|
|
Interventional |
Phase 1
Phase 2 |
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percent of patients who achieve a sustained PD response, defined to be at least 10% nuclear area positive at the day 8 biopsy
|
24 |
All |
18 Years to 120 Years (Adult, Senior) |
NCT01989546 |
140015
14-C-0015 |
|
November 16, 2013 |
August 6, 2019 |
August 6, 2019 |
November 21, 2013 |
April 4, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
| 25 |
NCT03117933 |
Recruiting |
Olaparib +/- Cediranib or Chemotherapy in Patients With BRCA Mutated Platinum-resistant Ovarian Cancer |
|
- Drug: Olaparib
- Drug: Cediranib
- Drug: Paclitaxel
|
Interventional |
Phase 2 |
- University of Oxford
- AstraZeneca
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression free survival
- Adverse events
- Overall Survival
- (and 2 more...)
|
132 |
Female |
16 Years and older (Child, Adult, Senior) |
NCT03117933 |
OCTO_062
2016-000559-28
16/LO/2150 |
OCTOVA |
March 9, 2017 |
March 30, 2021 |
November 30, 2021 |
April 18, 2017 |
January 23, 2018 |
|
- Mount Vernon Cancer Centre
Northwood, Middlesex, United Kingdom - Royal United Hospital
Bath, United Kingdom - Belfast City Hospital
Belfast, United Kingdom - (and 10 more...)
|
| 26 |
NCT03382574 |
Not yet recruiting |
Pilot Study of Denosumab in BRCA1/2 Mutation Carriers Scheduled for Risk-Reducing Salpingo-Oophorectomy |
- BRCA1 Gene Mutation
- BRCA2 Gene Mutation
- Fallopian Tube Carcinoma
- (and 2 more...)
|
- Biological: Denosumab
- Other: Laboratory Biomarker Analysis
- Procedure: Salpingo-Oophorectomy
|
Interventional |
Early Phase 1 |
- National Cancer Institute (NCI)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Ki67 proliferation index fallopian tube fimbrial epithelial cells assessed using immunohistochemistry (IHC)
- Ki67 proliferation index in ovarian surface epithelium and endometrium assessed using IHC
- Other tissue-based biomarkers in the fimbrial end of the fallopian tube, ovarian surface epithelium, and endometrium assessed by IHC
- (and 4 more...)
|
60 |
Female |
18 Years and older (Adult, Senior) |
NCT03382574 |
NCI-2017-02314
N01-CN-2012-00034
MDA2017-09-03
N01CN00034
P30CA016672 |
|
June 3, 2018 |
August 21, 2019 |
August 21, 2019 |
December 26, 2017 |
March 5, 2018 |
|
- Moffitt Cancer Center
Tampa, Florida, United States - Brigham and Women's Hospital
Boston, Massachusetts, United States - Dana-Farber Cancer Institute
Boston, Massachusetts, United States - (and 4 more...)
|
| 27 |
NCT01983410 |
Recruiting |
A Registry for BRCA Mutation Carriers With Pancreatic Ductal Adenocarcinoma |
- Pancreatic Ductal Adenocarcinoma
|
- Behavioral: The risk assessment questionnaire
- Other: Blood specimens
- Other: tumor tissue samples will be requested
|
Observational |
|
- Memorial Sloan Kettering Cancer Center
- Abramson Cancer Center of the University of Pennsylvania
- Shaare Zedek Medical Center
- (and 3 more...)
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
500 |
All |
21 Years and older (Adult, Senior) |
NCT01983410 |
13-217 |
|
November 4, 2013 |
November 2018 |
November 2018 |
November 14, 2013 |
February 27, 2018 |
|
- Memorial Sloan Kettering Cancer Center
New York, New York, United States - Abramson Cancer Center at University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States - Shaare Zedek Medical Center
Jerusalem, Israel - Sheba Medical Center
Tel Hashomer, Israel
|
| 28 |
NCT01670500 |
Recruiting |
Cisplatin vs. Doxorubicin/Cyclophosphamide in BrCa |
|
- Drug: Cisplatin
- Drug: Cyclophosphamide
- Drug: Doxorubicin
|
Interventional |
Phase 2 |
- Beth Israel Deaconess Medical Center
- Dana-Farber Cancer Institute
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- pCR to neoadjuvant cisplatin vs. pCR to AC
- Residual Cancer Burden after neoadjuvant cisplatin or AC
- Clinical response rate
- (and 3 more...)
|
170 |
All |
18 Years and older (Adult, Senior) |
NCT01670500 |
12-258 |
|
October 2012 |
October 2021 |
October 2021 |
August 22, 2012 |
December 18, 2017 |
|
- University of Colorado Cancer Center
Aurora, Colorado, United States - Smilow Cancer Hospital Care Center at Derby
Derby, Connecticut, United States - Smilow Cancer Hospital Care Center at Guilford
Guilford, Connecticut, United States - (and 19 more...)
|
| 29 |
NCT03475979 |
Not yet recruiting |
Abbreviated Breast MRI for Second Breast Cancer Detection in Women With BRCA Mutation Testing |
- Breast Cancer
- BRCA1 Mutation
- BRCA2 Mutation
- (and 2 more...)
|
|
Observational |
|
- Seoul National University Hospital
- Korean Society of Breast Imaging & Korean Society For Breast Screening
- Bayer
|
Other / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Sensitivity and Specificity (co-primary)
- Cancer detection rate (CDR)
- Positive predictive value (PPV)
- (and 2 more...)
|
1564 |
Female |
25 Years to 69 Years (Adult, Senior) |
NCT03475979 |
AB-MR for Second Breast Cancer |
|
April 2018 |
March 2021 |
March 2022 |
March 23, 2018 |
April 4, 2018 |
|
|
| 30 |
NCT03205761 |
Recruiting |
Analysis of Olaparib Response in Patients With BRCA1 and/or 2 Promoter Methylation Diagnosed of Advanced Breast Cancer |
|
|
Interventional |
Phase 2 |
- Spanish Breast Cancer Research Group
- AstraZeneca
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Response Rate to olaparib defined as the percentage of patients with a complete or partial response out of the total of patients of the efficacy population
- Clinical Benefit Rate (CBR) to olaparib defined as the percentage of patients with a complete response (CR), partial response (PR), or stable disease (SD) ≥ 24 weeks according to the RECIST version 1.1. out of the efficacy population
- Response Duration (RD) to olaparib defined as the time from the first documentation of objective tumour response (CR or PR) to the first documented progressive disease using RECIST version 1.1, or to death due to any cause, whichever occurs first.
- (and 8 more...)
|
34 |
Female |
18 Years and older (Adult, Senior) |
NCT03205761 |
GEICAM/2015-06
2016-001407-23
ESR-15-11274 |
COMETABreast |
September 13, 2017 |
December 2019 |
January 2020 |
July 2, 2017 |
January 10, 2018 |
|
- Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain - Hospital Universitario San Joan de Reus
Reus, Tarragona, Spain - Hospital del Mar
Barcelona, Spain - (and 13 more...)
|
| 31 |
NCT00823654 |
Recruiting |
Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer or BRCA Mutations |
|
- Other: Blood draw and questionnaires
|
Observational |
|
- Memorial Sloan Kettering Cancer Center
- Yale University
- New York Presbyterian Hospital
- Weill Medical College of Cornell University
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- characterize the changes in serum AMH from baseline to 1 year post-chemo (or 1 year into hormonal therapy if no chemotherapy planned)
- To characterize the changes in serum estradiol and FSH from baseline to one year postchemotherapy (or 1 year into hormonal therapy if no chemotherapy planned) in premenopausal breast cancer patients and BRCA mutation carriers.
- To characterize the changes over time in serum AMH, estradiol, and FSH in premenopausal breast cancer patients and unaffected high risk BRCA mutation carriers.
- (and 3 more...)
|
320 |
Female |
18 Years to 44 Years (Adult) |
NCT00823654 |
08-156 |
|
January 2009 |
January 2019 |
January 2019 |
January 15, 2009 |
February 21, 2018 |
|
- Memoral Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States - Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States - Memorial Sloan Kettering Commack
Commack, New York, United States - (and 4 more...)
|
| 32 |
NCT03119285 |
Recruiting |
Genes Contributing to Hereditary Ovarian Cancer in African American Women and BRCA1/2 Wildtype Families |
|
|
Observational |
|
|
Other |
- Observational Model: Other
- Time Perspective: Prospective
|
- Rate of deleterious germline mutations
|
150 |
All |
18 Years and older (Adult, Senior) |
NCT03119285 |
STUDY00001583 |
|
April 2013 |
April 2018 |
April 2018 |
April 18, 2017 |
October 26, 2017 |
|
- University of Washington
Seattle, Washington, United States
|
| 33 |
NCT01251900 |
Recruiting |
BRCA Mutations in Latinas |
|
|
Observational |
|
- National Cancer Institute (NCI)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Observational Model: Case-Only
- Time Perspective: Cross-Sectional
|
- Collection of saliva from 2000 probands
|
2000 |
Female |
18 Years to 99 Years (Adult, Senior) |
NCT01251900 |
999911035
11-C-N035 |
|
November 12, 2010 |
|
|
December 2, 2010 |
January 26, 2018 |
|
- Southwest Cancer Center, Lubbock; Texas Tech University
Lubbock, Texas, United States
|
| 34 |
NCT03162276 |
Recruiting |
Trial of Inquiry Based Stress Reduction (IBSR) Program for BRCA1/2 Mutation Carriers |
- Hereditary Breast and Ovarian Cancer Syndrome
|
- Behavioral: Inquiry Based Stress Reduction (IBSR) program
- Behavioral: Control
|
Interventional |
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The Ryff scale- Psychological well-being
- Life Orientation Test-Revise- LOT-R
- Satisfaction with life scale - SWLS d
- (and 8 more...)
|
118 |
Female |
25 Years to 55 Years (Adult) |
NCT03162276 |
SHEBA-17-3856-EF-CTIL |
|
July 1, 2017 |
October 1, 2020 |
December 30, 2020 |
May 22, 2017 |
July 6, 2017 |
|
- Eitan Friedman
Tel Hashomer, Israel - Sheba Medical Center
Tel-aviv, Israel
|
| 35 |
NCT03203993 |
Recruiting |
China Ovarian Cancer BRCA Testing Study |
|
|
Observational |
|
|
Industry |
- Observational Model: Case-Crossover
- Time Perspective: Prospective
|
- Proportion of newly diagnosed ovarian cancer patients with gBRCA and sBRCA mutations
- Progression-free survival (PFS)
- Overall survival (OS)
|
900 |
Female |
18 Years to 130 Years (Adult, Senior) |
NCT03203993 |
D133FR00117 |
CRONUS |
January 31, 2018 |
March 31, 2024 |
March 31, 2024 |
June 29, 2017 |
April 13, 2018 |
|
- Research Site
BeiJing, China - Research Site
Changsha, China - Research Site
Chengdu, China - (and 11 more...)
|
| 36 |
NCT00579488 |
Recruiting |
Clinical Significance of Germline BRCA Mutations |
- Breast Cancer
- Ovarian Cancer
|
|
Observational |
|
- Memorial Sloan Kettering Cancer Center
- Cold Spring Harbor Laboratory
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- To obtain DNA samples
- To obtain clinical and follow-up information on individuals being tested for BRCA mutations, in order to assess penetrance & phenotypic correlations of specific mutations, & to describe the outcome of medical or surgical interventions in heterozygotes.
- To establish a confidential registry/repository containing data on specific mutations and genomic variants and clinical feature as well as DNA for future gene discovery.
|
20000 |
All |
18 Years and older (Adult, Senior) |
NCT00579488 |
96-051 |
|
July 1996 |
July 2018 |
July 2018 |
December 24, 2007 |
August 28, 2017 |
|
- Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States - Memoral Sloan Kettering Monmouth
Middletown, New Jersey, United States - Memorial Sloan Kettering Commack
Commack, New York, United States - (and 3 more...)
|
| 37 |
NCT01689584 |
Recruiting |
COsegregation of VARiants in the BRCA1/2 and PALB2 Genes |
- Genes, BRCA1
- Genes, BRCA2
- Ovarian Neoplasms
- (and 2 more...)
|
|
Interventional |
Not Applicable |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Perform the co-segregation analysis of the selected VUS in the families in order to classify the maximum of variants in terms of their probability to be pathogenic
- • Propose a standardized method to classify VUS that can be integrated into the already existing classification established in the UMD-BRCA1/2 database, with the main focus on variants of class 4 (probably causal) and class 3 (unknown significance).
- • Maximize the number of VUS (both pathogenic and neutral) having associated recommendations for clinical management of at-risk relatives that can be used to guide genetic counselling.
- Assess the penetrance of several class 3 and 4 VUS probably associated with moderate cancer risk, using collected phenotype/genotype data on extended pedigrees.
|
2000 |
All |
18 Years and older (Adult, Senior) |
NCT01689584 |
IC 2011-11 |
COVAR |
April 2012 |
December 2022 |
December 2027 |
September 21, 2012 |
January 11, 2018 |
|
- Institut Curie - Hopital Rene Huguenin
Saint-Cloud, Haut De Seine, France - Institut Curie
Paris, Ile De France, France - CHU Amiens
Amiens, France - (and 54 more...)
|
| 38 |
NCT02953457 |
Recruiting |
Olaparib, Durvalumab, and Tremelimumab in Treating Patients With Recurrent or Refractory Ovarian, Fallopian Tube or Primary Peritoneal Cancer With BRCA1 or BRCA2 Mutation |
- BRCA1 Gene Mutation
- BRCA2 Gene Mutation
- Ovarian Serous Adenocarcinoma
- (and 3 more...)
|
- Biological: Durvalumab
- Other: Laboratory Biomarker Analysis
- Drug: Olaparib
- Biological: Tremelimumab
|
Interventional |
Phase 1
Phase 2 |
- Roswell Park Cancer Institute
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Incidence of dose-limiting toxicities (DLTs) defined as the rate of drug-related grade 3-5 adverse events assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (Phase I)
- Progression free survival (PFS) in the platinum resistant group (Phase II)
- Progression free survival (PFS) in the platinum sensitive group (Phase II)
- (and 3 more...)
|
39 |
Female |
18 Years and older (Adult, Senior) |
NCT02953457 |
I 288216
NCI-2016-01598
P30CA016056 |
|
June 29, 2017 |
August 15, 2019 |
August 15, 2020 |
November 2, 2016 |
February 9, 2018 |
|
- Roswell Park Cancer Institute
Buffalo, New York, United States
|
| 39 |
NCT02571725 |
Recruiting |
PARP-inhibition and CTLA-4 Blockade in BRCA-deficient Ovarian Cancer |
- Ovarian Cancer
- Fallopian Tube Cancer
- Peritoneal Neoplasms
|
- Drug: Olaparib
- Drug: Tremelimumab
|
Interventional |
Phase 1
Phase 2 |
- New Mexico Cancer Care Alliance
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Phase 1: Recommended Phase 2 Dose (RP2D)
- Phase 2: Objective response rate (ORR)
- Phase 2: Progression free survival (PFS)
|
50 |
Female |
18 Years and older (Adult, Senior) |
NCT02571725 |
INST 1419 |
|
February 2016 |
February 2020 |
February 2022 |
October 8, 2015 |
March 29, 2018 |
|
- University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States
|
| 40 |
NCT02595905 |
Recruiting |
Cisplatin With or Without Veliparib in Treating Patients With Recurrent or Metastatic Triple-Negative and/or BRCA Mutation-Associated Breast Cancer With or Without Brain Metastases |
- Breast Carcinoma Metastatic in the Brain
- Deleterious BRCA1 Gene Mutation
- Deleterious BRCA2 Gene Mutation
- (and 6 more...)
|
- Drug: Cisplatin
- Other: Laboratory Biomarker Analysis
- Other: Placebo
- Drug: Veliparib
|
Interventional |
Phase 2 |
- National Cancer Institute (NCI)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-free survival (PFS)
- Overall survival (OS)
- Response rate (measurable disease only)
- Clinical benefit rate
|
333 |
All |
18 Years and older (Adult, Senior) |
NCT02595905 |
NCI-2015-01912
S1416
U10CA180888 |
|
July 7, 2016 |
October 31, 2021 |
|
November 4, 2015 |
April 24, 2018 |
|
- Anchorage Associates in Radiation Medicine
Anchorage, Alaska, United States - Anchorage Radiation Therapy Center
Anchorage, Alaska, United States - Alaska Breast Care and Surgery LLC
Anchorage, Alaska, United States - (and 766 more...)
|
| 41 |
NCT02950064 |
Recruiting |
A Study to Determine the Safety of BTP-114 for Treatment in Patients With Advanced Solid Tumors With BRCA Mutations |
- Pancreatic Neoplasms
- Ovarian Neoplasms
- Breast Neoplasms
- Prostatic Neoplasms
|
|
Interventional |
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Part 1 - Maximum tolerated dose (MTD) of BTP-114 determined during the dose escalation phase of study based on number of patients experiencing a dose-limiting toxicity.
- Part 1 - Recommended Phase 2 Dose (RP2D) of BTP-114 based on the MTD, review of adverse event data and review of AUC, Tmax and t1/2 obtained from PK data during the dose escalation phase of the study.
- Part 1 - Number of patients experiencing treatment-related adverse events as assessed by CTCAE v4.3 during the study.
- (and 4 more...)
|
95 |
All |
18 Years and older (Adult, Senior) |
NCT02950064 |
BTP-114-001 |
|
September 2016 |
April 2020 |
August 2020 |
October 31, 2016 |
October 17, 2017 |
|
- Placon Therapeutics Clinical Trial Site
Sarasota, Florida, United States - Placon Therapeutics Clinical Trial Site
Boston, Massachusetts, United States - Placon Therapeutics Clinical Trial Site
Boston, Massachusetts, United States - (and 6 more...)
|
| 42 |
NCT02670668 |
Not yet recruiting |
Mutation of BRCA1/2 and Other Potential Genes in Triple-negative Breast Cancer |
|
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Gene mutation prevalence of tBRCA1/2, HRR, or other chemo-response related genes in TNBC patients between pCR and SD/PD, which achieved after NAC
- To evaluate potential relationship between these gene mutations and NAC-response in TNBC patients
|
100 |
All |
Child, Adult, Senior |
NCT02670668 |
ESR-14-10562 |
|
January 2016 |
December 2017 |
December 2018 |
February 2, 2016 |
February 2, 2016 |
|
- Department of Breast Surgery, Cancer Hospital, Fudan University
Shanghai, Shanghai, China
|
| 43 |
NCT00496288 |
Recruiting |
Prophylactic Irradiation to the Contralateral Breast for BRCA Mutation Carriers Undergoing Treatment for Breast Cancer |
|
- Radiation: Prophylactic radiation to the contralateral breast
|
Interventional |
Phase 2 |
- Assaf-Harofeh Medical Center
- Rambam Health Care Campus
- Tel-Aviv Sourasky Medical Center
- (and 4 more...)
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Rate of contralateral breast cancer in carrier patients that received prophylactic radiation to the contralateral breast compared with carrier patients that did not receive that treatment.
- Short and long term adverse effects of prophylactic contralateral breast irradiation.
- factors that influence patient's choice of treatment
|
240 |
Female |
30 Years to 90 Years (Adult, Senior) |
NCT00496288 |
102/07 (HT4351) |
|
March 2008 |
March 2023 |
|
July 4, 2007 |
April 5, 2011 |
|
- Assaf-Harofeh Medical Center
Zerrifin, Israel
|
| 44 |
NCT03402841 |
Recruiting |
Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients |
- Non-Germline BRCA Mutated Ovarian Cancer
|
|
Interventional |
Phase 3 |
- AstraZeneca
- Quintiles, Inc.
- Myriad Genetics, Inc.
- (and 3 more...)
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Progression-free survival (PFS)
- Time to first subsequent therapy or death (TFST)
- Time to treatment discontinuation or death (TDT)
- (and 4 more...)
|
265 |
Female |
18 Years and older (Adult, Senior) |
NCT03402841 |
D0816C00020 |
OPINION |
January 30, 2018 |
September 28, 2020 |
September 28, 2020 |
January 18, 2018 |
April 6, 2018 |
|
- Research Site
Graz, Austria - Research Site
Innsbruck, Austria - Research Site
Wein, Austria - (and 45 more...)
|
| 45 |
NCT03499353 |
Not yet recruiting
New |
Talazoparib For Neoadjuvant Treatment Of Germline Brca1/2 Mutation Patients With Early Triple-negative Breast Cancer |
|
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pathological Complete Response (pCR) by Independent Central Reviewer(ICR)
- pCR by Investigator
- Residual Cancer Burden(RCB) by Independent reviewer
- (and 10 more...)
|
122 |
All |
18 Years and older (Adult, Senior) |
NCT03499353 |
C3441020
TALAZOPARIB NEOADJ BC |
|
April 26, 2018 |
October 25, 2020 |
February 25, 2023 |
April 17, 2018 |
April 17, 2018 |
|
|
| 46 |
NCT02810743 |
Recruiting |
Substantially Improving the Cure Rate of High-risk BRCA1-like Breast Cancer |
|
- Drug: ddAC-CP-Olaparib
- Drug: ddAC-mini CTC
|
Interventional |
Phase 3 |
- The Netherlands Cancer Institute
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall survival
- Recurrence free interval
- Incidence of toxicity, graded according to National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 4.03
- (and 3 more...)
|
174 |
All |
18 Years to 65 Years (Adult) |
NCT02810743 |
M16BRC |
Subito |
August 2016 |
August 2019 |
August 2029 |
June 23, 2016 |
September 14, 2017 |
|
- Institut Paoli Calmettes
Marseille, France - Hopital Tenon, University Marie-Curie
Paris, France - Heinrich Heine University Düsseldorf, Women's Health Study Group
Dusseldorf, Germany - (and 9 more...)
|
| 47 |
NCT02903004 |
Recruiting |
Trial on Trabectedin (ET-743) vs Clinician's Choice Chemotherapy in Recurrent Ovarian, Primary Peritoneal or Fallopian Tube Cancers of BRCA Mutated or BRCAness Phenotype Patients _MITO-23 |
|
- Drug: Trabectedin
- Drug: Pegylated Liposomal Doxorubicin
- Drug: Topotecan
- (and 3 more...)
|
Interventional |
Phase 3 |
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Overall Survival (OS)
- Progression free survival (PFS)
- Duration of Response
- Adverse events
|
244 |
Female |
18 Years and older (Adult, Senior) |
NCT02903004 |
INT 181/15 |
Mito23 |
April 2016 |
April 2020 |
April 2020 |
September 16, 2016 |
September 16, 2016 |
|
- Domenica Lorusso
Milan, Italy
|
| 48 |
NCT02598895 |
Recruiting |
Docetaxel and Carboplatin in Treating Patients With Metastatic, Castration Resistant Prostate Cancer Containing Inactivated Genes in the BRCA 1/2 Pathway |
- Castration Levels of Testosterone
- Castration-Resistant Prostate Carcinoma
- Metastatic Prostate Carcinoma
- (and 3 more...)
|
- Drug: Carboplatin
- Drug: Docetaxel
- Other: Laboratory Biomarker Analysis
|
Interventional |
Not Applicable |
- University of Washington
- National Cancer Institute (NCI)
|
Other / NIH |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Proportion of patients with PSA decline by 50% from baseline according to Prostate Cancer Working Group 2 (PCWG2) criteria
- Median time to disease progression (Prostate Cancer Working Group 2 [PCWG2] criteria)
- Number of patients with deoxyribonucleic acid (DNA) repair pathway mutations in circulating tumor cell (CTC) and cell free DNA
- (and 3 more...)
|
14 |
Male |
18 Years and older (Adult, Senior) |
NCT02598895 |
9381
NCI-2015-01694
P30CA015704
P50CA097186 |
|
January 26, 2016 |
June 30, 2018 |
|
November 6, 2015 |
November 6, 2017 |
|
- Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
|
| 49 |
NCT03009682 |
Recruiting |
Olaparib Monotherapy in Relapsed Small Cell Lung Cancer Patients With HR Pathway Gene Mutations Not Limited to BRCA 1/2 Mutations, ATM Deficiency or MRE11A Mutations |
|
|
Interventional |
Phase 2 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Objective response rate (ORR) by RECIST 1.1
- Duration of response
- Disease control rate
- (and 3 more...)
|
28 |
All |
20 Years and older (Adult, Senior) |
NCT03009682 |
2016-03-078 |
SUKSES-B |
August 2016 |
December 2018 |
June 2019 |
January 4, 2017 |
September 29, 2017 |
|
- Samsung Medical Center
Seoul, Korea, Republic of
|
| 50 |
NCT02476968 |
Recruiting |
To Assess the Efficacy and Safety of Olaparib Maintenance Monotherapy in the Treatment of Ovarian Cancer |
- BRCA or HRR+ Mutated Ovarian Cancer Patients
|
|
Interventional |
Phase 4 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Time from study enrolment to disease progression (assessed according to RECIST 1.1 guidelines) or death.
- Time to death and Time to second progression event or death if this occurs before second progression event.
- Time to first and second treatment commencement or death and time to olaparib discontinuation or death.
- (and 2 more...)
|
275 |
Female |
18 Years to 130 Years (Adult, Senior) |
NCT02476968 |
D0816C00012 |
ORZORA |
September 28, 2015 |
November 22, 2019 |
November 22, 2019 |
June 22, 2015 |
February 8, 2018 |
|
- Research Site
Pleven, Bulgaria - Research Site
Plovdiv, Bulgaria - Research Site
Plovdiv, Bulgaria - (and 77 more...)
|
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