UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055219 |
|---|---|
| Receipt number | R000063061 |
| Scientific Title | Cross-sectional study to assess the penetration of gBRCA1/2 genetic testing within HER2-negative recurrent high-risk early-breast cancer patients (BRCAwareness) |
| Date of disclosure of the study information | 2024/08/11 |
| Last modified on | 2024/11/02 09:55:22 |
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Basic information
Public title
Cross-sectional study to assess the penetration of gBRCA1/2 genetic testing within HER2-negative recurrent high-risk early-breast cancer patients (BRCAwareness)
Acronym
Cross-sectional study on BRCA testing in recurrent high-risk EBC
Scientific Title
Cross-sectional study to assess the penetration of gBRCA1/2 genetic testing within HER2-negative recurrent high-risk early-breast cancer patients (BRCAwareness)
Scientific Title:Acronym
Cross-sectional study on BRCA testing in recurrent high-risk EBC
Region
| Japan |
Condition
Condition
Recurrent high-risk HER2-negative early-breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Adjuvant olaparib in patients with recurrent high-risk HER2-negative early-breast cancer who have gBRCA1/2 pathogenic variant (gBRCA positive) has been reported to improve prognosis and was covered by national insurance in Japan in August 2022. However, olaparib cannot be used without companion diagnostic gBRCA1/2 genetic testing. The exact proportion of gBRCA1/2 genetic testing in patients with recurrent high-risk HER2-negative early breast cancer is not known. The identification of eligible patients is important because it can improve prognosis.
Basic objectives2
Others
Basic objectives -Others
To determine the proportion of gBRCA1/2 genetic testing performed in recurrent high-risk HER2-negative early-breast cancer patients who are candidate to olaparib
To explore factors associated with not taking gBRCA1/2 genetic testing
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of gBRCA1/2 genetic testing performed
Key secondary outcomes
Factors associated with not taking gBRCA1/2 genetic testing
Proportion of patients with gBRCA1/2 pathogenic variants among those who underwent gBRCA1/2 genetic testing
Proportion of patients initiated on olaparib among gBRCA1/2 pathogenic variant holders
Drug therapy used other than olaparib in gBRCA1/2 pathogenic variant carriers
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All of the following criteria must be met as primary enrollment.
1.Newly diagnosed invasive breast cancer
2.No distant metastasis from the time of diagnosis to surgery
3.18 years or older at the time of diagnosis
4.HER2 negative (Definition of HER2 negative: 0 or 1+ by immunohistochemistry (IHC), or HER2/CEP17 ratio <2.0 and HER2 copy number <6.0 by fluorescence in situ hybridization (FISH))
5.Underwent radical surgery (mastectomy or partial mastectomy) for breast cancer between January 1, 2023 and December 31, 2023
6.Estrogen receptor (ER)-positive (ER-positive cells account for >=1% by IHC)
6-1.Four lymph node metastases (>=pN2) after prior surgery
6-2.Non-pCR (with residual invasive cancer cells) after preoperative chemotherapy
7.ER-negative (ER-positive cells account for <1% by IHC)
7-1.Invasive tumor >2 cm in diameter (>=pT2) or one lymph node metastasis (>=pN1) after prior surgery
7-2.Non-pCR (with residual invasive cancer cells) after preoperative chemotherapy
To proceed to secondary enrollment, patients must have a CPS+EG score of at least 3 points if they meet the following criteria
6.ER-positive and 2.non-pCR after preoperative chemotherapy
Key exclusion criteria
Cases deemed ineligible by the attending physician
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Tomoe |
| Middle name | |
| Last name | Taji |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Department of Breast Surgery
Zip code
660-8550
Address
2-17-77 Higashinaniwa-cyo, Amagasaki, Hyogo, JAPAN
TEL
0664807000
tajit@hp.pref.hyogo.jp
Public contact
Name of contact person
| 1st name | Tomoe |
| Middle name | |
| Last name | Taji |
Organization
Hyogo Prefectural Amagasaki General Medical Center
Division name
Department of Breast Surgery
Zip code
660-8550
Address
2-17-77 Higashinaniwa-cyo, Amagasaki, Hyogo, JAPAN
TEL
06-6480-7000
Homepage URL
tajit@hp.pref.hyogo.jp
Sponsor or person
Institute
Hyogo Prefectural Amagasaki General Medical Center
Institute
Department
Personal name
Funding Source
Organization
AstraZeneca
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University Hospital
Address
2-3-1, Shinmachi, Hirakata, Osaka, JAPAN
Tel
072-804-0101
tajit@hp.pref.hyogo.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 06 | Month | 30 | Day |
Other
Other related information
(1) Primary registration
The following items (patient information) will be entered into the EDC (electronic data capture) from the electronic medical record for patients with recurrent high-risk HER2-negative early-breast cancer who underwent surgery between January 1, 2023 and December 31, 2023.
1.Age
2.Gender
3.Treatment strategy (prior surgery or preoperative chemotherapy)
4.Information on clinical stage (cTNM classification)
5.Information on histopathology diagnosis (ER, PgR, HER2, pTNM classification, nuclear or histological grade)
6.Date of surgery
The following items (facility information) will be collected from registered facilities.
7.Number of certified genetic counselors (full-time and part-time)
8.Number of clinical geneticists
9.Number of breast specialists
10.Number of certified breast cancer nurses
11.Description on gBRCA1/2 genetic test
12.Perioperative conferences held or not
13.Number of breast cancer surgeries per year
14.The level of accreditation of JOHBOC
(2) Secondary registration
1.Menopausal status, pregnancy, and childbearing status for women
2.Family history of cancer (breast, ovarian, pancreatic)
3.Past medical history and comorbidities
4.Information on Surgery
5.Information on drug therapy
6.Information on gBRCA1/2 genetic testing (whether test was taken, and the results of those who took the test)
7.Description of gBRCA1/2 genetic testing
The above information will be used to determine the proportion of gBRCA1/2 genetic testing among patients with recurrent high-risk HER2-negative early breast cancer. In addition, we will identify factors associated with not undergoing gBRCA1/2 genetic testing. We will also examine postoperative drug therapy among gBRCA1/2 pathogenic variant carriers.
Management information
Registered date
| 2024 | Year | 08 | Month | 11 | Day |
Last modified on
| 2024 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063061
