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Cohort Study of Patients With HER2-negative MBC and BRCA 1/2 Pathogenic Mutation (BRCAm)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368442
Recruitment Status : Recruiting
First Posted : April 29, 2020
Last Update Posted : April 29, 2020
Sponsor:
Information provided by (Responsible Party):
Yeon Hee Park, Samsung Medical Center

Brief Summary:
The purpose of this study is to investigate the prevalence germline pathogenic BRCA1/2 mutation in a large group of potential candidate of PARP inhibitors, among the unselected patients with HER2-negative unresectable locally advanced or metastatic breast cancer.

Condition or disease
Breast Cancer Metastatic

Detailed Description:

This is a multicenter, prospective, non-interventional study on the prevalence of germline pathogenic BRCA1/2 mutation (Blood) and somatic pathogenic BRCA1/2 mutation (Tissue, optional) in patients with HER2-negative unresectable locally advanced or metastatic breast cancer.

  1. For the assessment of germline mutational status of BRCA1 and BRCA2, (1)Collect peripheral blood from each subject. (2) Extract DNA from the collected blood. (3)From the extracted DNA, germline BRCA1/2 mutational status will be assessed by next generation sequencing(NGS) using NGeneBioBRCAaccuTest®
  2. For the assessment of somatic mutational status of BRCA1 and BRCA2, (1)Collect FFPE from about 100 subjects. (2) Extract DNA from the FFPE. (3)From the extracted DNA, somatic BRCA1/2 mutational status will be assessed by next generation sequencing(NGS) using NGeneBioBRCAaccuTest®
  3. Collect variables on the patients and compare clinical outcomes (Overall survival, Invasive Disease-free survival, Distant Disease-free survival, Progression free survival) that can be affected by clinicopathologic characteristics and type of treatment.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 583 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Epidemiologic Evaluation and Clinical Outcomes for HER2-negative Metastatic Breast Cancer (MBC) Patients With Germline BRCA1 and 2 Pathogenic Mutation in Korea
Actual Study Start Date : October 17, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Progression free survival [ Time Frame: Length of time from the first date of each line of palliative endocrine treatment or chemotherapy until the date of the first documented progression of breast cancer or death of any cause,, assessed up to 60 months ]
    Progression free survival of each of palliative systemic treatment


Secondary Outcome Measures :
  1. Overall survival 1 [ Time Frame: Length of time from the date of first neoadjuvant chemotherapy or curative surgery until death for any cause,, assessed up to 60 months ]
    Overall survival from initial diagnosis

  2. Overall survival 2 [ Time Frame: Length of time from the first date of the first line of chemotherapy, assessed up to 60 months ]
    Overall survival from diagnosis of unresectable locally advanced/MBC

  3. Disease-free survival [ Time Frame: Length of time from the date of first neoadjuvant chemotherapy or curative surgery until the date of the first recurrence of breast cancer, diagnosis of second invasive cancer, or death for any cause whichever comes first, assessed up to 60 months ]
    Invasive Disease-free survival


Biospecimen Retention:   Samples With DNA
  1. DNA form the peripheral blood
  2. (optional) Extracted DNA from the FFPE


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Korean patients with HER2-negative unresectable locally advanced or metastatic breast cancer
Criteria

Inclusion Criteria:

  • Age ≥ 20 years old
  • Histologically confirmed, unresectable locally advanced or metastatic breast invasive carcinoma
  • Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer
  • Germline mutational status of BRCA1 and/or BRCA2 can be known or unknown
  • Signed written informed consent
  • The patient is regarded as good candidate for active palliative management at time of enrollment. The patient with terminal cancer which is not appropriate for further endocrine treatment or chemotherapy cannot be enrolled to this study.

Exclusion Criteria:

  • HER2 positive breast cancer
  • Amenable to curative surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368442


Contacts
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Contact: YEON HEE MD PARK 82-2-3410-1780 yhparkhmo@skku.edu

Locations
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Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Yeon-Hee Park, MD, Ph.D    82-2-3410-1780    yeonh.park@samsung.com   
Sponsors and Collaborators
Samsung Medical Center
Investigators
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Principal Investigator: YEON HEE PARK Samsung Medical Center
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Responsible Party: Yeon Hee Park, M.D., Ph.D., Division of hematology and oncology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT04368442    
Other Study ID Numbers: 2019-06-027
First Posted: April 29, 2020    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yeon Hee Park, Samsung Medical Center:
BRCA
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases