UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029433 |
|---|---|
| Receipt number | R000029940 |
| Scientific Title | Prospective study of neoadjuvant chemotherapy with FEC100x4 for BRCAness cases in triple negative breast cancer |
| Date of disclosure of the study information | 2017/10/05 |
| Last modified on | 2025/04/10 10:43:02 |
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Basic information
Public title
Prospective study of neoadjuvant chemotherapy with FEC100x4 for BRCAness cases in triple negative breast cancer
Acronym
Neoadjuvant chemotherapy for BRCAness
Scientific Title
Prospective study of neoadjuvant chemotherapy with FEC100x4 for BRCAness cases in triple negative breast cancer
Scientific Title:Acronym
Neoadjuvant chemotherapy for BRCAness
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The efficacy of anthracycline based chemotherapy is investigated for BRCAness
homologous recombination deficiency cases in triple negative breast cancer patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pathologic complete response(pCR)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Patients who have obtained consent from tis study will start neoadjuvant chemotherapy with the following 3 anti-cancer drugs every 3 weeks for a total of 4 cycles.
Fluorouracil 500mg/m2 Epirubicin 100mg/m2 Cyclophosphamide 100m/m2
BRCAness is examined and cases with non-BRCAness will be taken Taxan every 3 weeks, for a total of 4 cycles.
Interventions/Control_2
Cases with BRCAness will undergo surgery without adding Taxan. If pCR is not obtained, Taxan will be given.
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Patients with primary breast cancer who indicates the neoadjuvant chemotherapy from stage 1-3
2.PS 0-1
3.normal cardiac function
4.clinical examination is normal
Key exclusion criteria
1.Patients who have been administered moderate doses of anti-cancer drugs.
2.Patients who have been undergone gastrointestinal surgery
3.Active double cancers
4.Pregnant, lactating, possible pregnancy, having oral contraceptive
5.Patients who the investigator judged unsuitable for this trial
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Ishikawa |
Organization
Tokyo medical university hospital
Division name
breast oncology
Zip code
1600023
Address
6-1-1 Nishishinnjyuku Shinjyuku-ku Tokyo
TEL
0333516141
tishik55@gmail.com
Public contact
Name of contact person
| 1st name | Saeko |
| Middle name | |
| Last name | Teraoka |
Organization
Tokyo medical university hospital
Division name
breast oncology
Zip code
1600023
Address
6-1-1 Nishishinnjyuku Shinjyuku-ku Tokyo
TEL
0333516141
Homepage URL
s_teraoka0809@yahoo.co.jp
Sponsor or person
Institute
Tokyo medical university
Institute
Department
Personal name
Funding Source
Organization
Tokyo medical university cancer institute.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
FALCO biosystems
Name of secondary funder(s)
IRB Contact (For public release)
Organization
TokyoMedicalUniversityHospital
Address
6-7-1 Nishishinnjyuku Shinjyuku-ku Tokyo
Tel
0333426111
s_teraoka0809@yahoo.co.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
| 2017 | Year | 10 | Month | 05 | Day |
Related information
URL releasing protocol
https://www.clinical-breast-cancer.com/article/S1526-8209(24)00297-0/fulltext
Publication of results
Unpublished
Result
URL related to results and publications
https://www.clinical-breast-cancer.com/article/S1526-8209(24)00297-0/fulltext
Number of participants that the trial has enrolled
224
Results
The overall detection rate by MMG was 82.6% and significantly lower in patients with dense breasts (74.4%) compared to non-dense breasts (93.7%). The overall detection rate by AICS breast was 50.0%, with no difference between patients with dense breasts (45.7%) and those with non-dense breasts (55.8%). The combination of MMG and AICS breast increased the detection rate to 91.5% overall, 88.3% in patients with dense breasts, and 95.8% in those with non-dense breasts.
Results date posted
| 2025 | Year | 04 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study included breast cancer patients who participated before undergoing surgery. The enrollment period was 26 months, from January 2017 to March 2019.
The median age was 60.7 years.The median body mass index was 22.8.
In MMG, the breast density was categorized as follows: 21 individuals (9.4%) had extremely dense breasts, 108 individuals (48.2%) had heterogeneous dense breasts, 67 individuals (29.9%) had scattered breasts, and 28 individuals (12.5%) had fatty breasts. Dense breasts (i.e., extremely dense and heterogeneous dense) were present in 129 individuals (57.6%), while non-dense breasts (scattered + fatty) were present in 95 individuals (42.4%).
Participant flow
We explained the trial outline to patients scheduled for surgery at Tokyo Medical University and included those who agreed to participate in the trial. Participants were asked to cooperate with blood sampling before the surgery.
Adverse events
Since it only involved imaging diagnosis and blood tests, no adverse events associated with this exam were observed.
Outcome measures
PFAA concentration was measured using liquid chromatography-mass spectrometry, and the AICS breast and AICS ranks were calculated. Detection rates were compared between MMG (categories 3-5) and AICS breasts (ranks B and C) according to breast density.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 05 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 05 | Day |
Last modified on
| 2025 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029940
