UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037505
Receipt number R000042740
Scientific Title Validation study of the prognostic and predictive value of TP53 signature for breast cancer
Date of disclosure of the study information 2019/09/18
Last modified on 2021/07/27 14:16:37

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Basic information

Public title

Validation study of the prognostic and predictive value of TP53 signature for breast cancer

Acronym

Validation study of the prognostic and predictive value of TP53 signature for breast cancer

Scientific Title

Validation study of the prognostic and predictive value of TP53 signature for breast cancer

Scientific Title:Acronym

Validation study of the prognostic and predictive value of TP53 signature for breast cancer

Region

Japan


Condition

Condition

Breast Cancer

Classification by specialty

Hematology and clinical oncology Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to validate whether the TP53 status diagnosed by the TP53 signature diagnostic kit can predict the prognosis and the therapeutic effect of neoadjuvant chemotherapy in breast cancer patients.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Pathological complete response rate

Key secondary outcomes



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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

The subjects are the patients enrolled in the following five clinical trials conducted by JBCRG and OOTR.
i. JBCRG-01 (n=202)
ii. JBCRG-02 (n=31)
iii. JBCRG-02' (n=19)
iv. JBCRG-03 (n=130)
v. OOTR-N003 (n=500)
In addition, perioperative chemotherapy-free hormone receptor positive breast cancer (HR+BC) patients will be collected targeting at 340 cases.
Selection criteria for perioperative chemotherapy-free HR+BC cases are as follows according to the eligibility criteria of the above five clinical trials.
Cases that satisfy all the following 1 to 7
1. Cases with histologically confirmed primary breast cancer (invasive cancer) and undergone curative resection
2. Cases in which TNM at diagnosis satisfies the following {cT1 c-3 cN0 cM0 (> 1 cm) / cT1-3 cN1 cM0}
3. Cases in which chemotherapy were not given as preoperative or postoperative adjuvant therapy (cases in which endocrine therapy were given are acceptable)
4. 20 years old or older and less than 70 years old
5. Cases in which regular follow-up has been performed at the facility where surgery for breast cancer was performed and of whom sufficient prognostic information can be obtained (Follow-up period must be over 5 years in cases without recurrence).
6. Cases in which the following samples can be submitted
Cases with preoperative endocrine therapy: Biopsy tumor samples obtained before endocrine therapy (formalin fixed paraffin embedded tissue, total of 12 slides of 4 micro meter thick unstained specimens)
Cases without preoperative endocrine therapy: Biopsy tumor samples at diagnosis or tumor samples resected by surgery (formalin fixed paraffin embedded tissue, total of 12 slides of 4 micro meter thick unstained specimens)
7. Cases diagnosed with primary breast cancer between August 2005 and July 2009
The number of cases in each facility is limited to 60 cases, and all eligible cases after August 2005 have to be registered consecutively.

Key exclusion criteria

1. Male
2. Cases judged by investigator to be unfit to be enrolled into the study

Target sample size

840


Research contact person

Name of lead principal investigator

1st name Chikashi
Middle name
Last name Ishioka

Organization

Institute of Development, Aging and Cancer, Tohoku University

Division name

Department of Clinical Oncology

Zip code

980-8575

Address

4-1, Seiryo-machi, Aobaku, Sendai, Miyagi, Japan

TEL

022-717-8543

Email

chikashi@tohoku.ac.jp


Public contact

Name of contact person

1st name Shin
Middle name
Last name Takahashi

Organization

Institute of Development, Aging and Cancer, Tohoku University

Division name

Department of Clinical Oncology

Zip code

980-8575

Address

4-1, Seiryo-machi, Aobaku, Sendai, Miyagi, Japan

TEL

022-717-8543

Homepage URL


Email

shin.takahashi.e7@tohoku.ac.jp


Sponsor or person

Institute

Japan Agency for Medical Research and Development

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Tohoku University Hospital Research Ethics Committee

Address

1-1, Seiryo-machi, Aobaku, Sendai, Miyagi, Japan

Tel

022-728-4105

Email

ec@rinri.hosp.tohoku.ac.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

2019 Year 09 Month 18 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications


Number of participants that the trial has enrolled

800

Results

A total of 800 specimens were collected from 23 sites in Japan, and TP53 signature data were obtained for a total of 753 cases, excluding insufficient specimen cases (wild-type (wt) 361 cases and mutant (mt) 392 cases).In a preoperative chemotherapy cohort, the pCR ratio in the mt group was significantly higher than that of wt group (the estimate of the common odds ratio of the mt group for the wt group: 5.599, 95% CI: 1.876-16.705, p=0.0008).

Results date posted

2021 Year 07 Month 27 Day

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

Completed

Date of protocol fixation

2019 Year 09 Month 10 Day

Date of IRB

2019 Year 09 Month 26 Day

Anticipated trial start date

2019 Year 09 Month 26 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry

2021 Year 03 Month 31 Day

Date trial data considered complete

2021 Year 03 Month 31 Day

Date analysis concluded

2021 Year 03 Month 31 Day


Other

Other related information

We verify that the pCR ratio in patients diagnosed with mt by TP53 signature is higher than that in patients diagnosed with wt in patients treated with preoperative chemotherapy.
To match the patients background between TP53 signature status, we use propensity score (PS) estimated by logistic regression analysis. The covariates are ER, PgR, Ki67, age, menopausal status, tumor diameter, lymph node status and vascular invasion. We divide patients into 3 groups by PS so that the number of patients in the stratum is equal. The pCR ratio, the 95% confidence interval by the Cloper-Pearson method and the odds ratio are calculated in the patients with mt and wt by TP53 signature, respectively. In addition, the null hypothesis that the common odds ratio is 1 is tested at a two-sided significance level of 5% using the Mantel-Haenszel test.


Management information

Registered date

2019 Year 07 Month 26 Day

Last modified on

2021 Year 07 Month 27 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042740


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name