UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000003570
Receipt number	R000004273
Scientific Title	A phase II study of metronomic paclitaxel + cyclophosphamide + capecitabine (PCX) followed by 5-fluorouracil + epirubicin + cyclophosphamide (FEC) as preoperative chemotherapy for triple negative or low hormone receptors/HER2 negative primary breast cancer (JBCRG-13)
Date of disclosure of the study information	2010/05/10
Last modified on	2021/08/18 10:23:10

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Basic information

Public title

A phase II study of metronomic paclitaxel + cyclophosphamide + capecitabine (PCX) followed by 5-fluorouracil + epirubicin + cyclophosphamide (FEC) as preoperative chemotherapy for triple negative or low hormone receptors/HER2 negative primary breast cancer (JBCRG-13)

Acronym

JBCRG-13

Scientific Title

Scientific Title:Acronym

JBCRG-13

Region

Japan

Condition

Operable triple negative or low hormone receptors/HER2 negative primary breast cancer

Classification by specialty

Hematology and clinical oncology Surgery in general Breast surgery

Classification by malignancy

Malignancy

Genomic information

YES

Objectives

Narrative objectives1

To evaluate the efficacy and safety of metronomic paclitaxel + cyclophosphamide + capecitabine (PCX) followed by 5-fluorouracil, epirubicin + cyclophosphamide (FEC) as preoperative chemotherapy for triple negative or low hormone receptors/HER2 negative primary breast cancer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II

Assessment

Primary outcomes

Pathological complete response rate

Key secondary outcomes

Overall response rate, Safety, Breast conservation rate, Overall survival, Disease-free survival

Base

Study type

Interventional

Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

No. of arms

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Metronomic PCX + FEC: 4 cycles of metronomic PCX therapy* followed by 4 cycles of FEC therapy**

* metronomic PCX regimen:
Paclitaxel 80mg/m2 iv day1,8,15 weekly
Cyclophosphamide 50mg/body po day1-21 daily
Capecitabine 1200mg/m2 po day1-21 daily
Q3weeks

** FEC regimen:
5-Fluorouracil 500mg/m2 iv day 1
Epirubicin 100mg/m2 iv day 1
Cyclophosphamide 500mg/m2 iv day 1
Q3weeks

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

20 years-old <=

Age-upper limit

70 years-old >=

Gender

Female

Key inclusion criteria

1) Female primary breast cancer patients who are diagnosed as triple negative or low hormone receptors/HER2 negative
[T1C-3 N0 M0 (> 1cm)/ T1-3 N1 M0: at first diagnosis].
2) Histological confirmed invasive breast cancer by biopsy.
3) Absent or low expression of Estrogen receptor(ER) and Progesterone receptor(PR) (IHC < 10%) and HER2 negative (IHC 1+/0 or IHC 2+/FISH-).
4) Age between 20 years old and 70 years old.
5) Measurable region.
6) Adequate major organ function;
a) WBC >= 4,000/mm3, or ANC >= 2,000/mm3
b) PLT >= 100,000/mm3
c) Hb >= 9.0 g/dL
d) AST, ALT <= 2.5 x ULN
e) T. Bil or direct Bil <= 1.5 x ULN
f) Serum Cr. <= 1.5 x ULN
g) Creatinine clearance >= 50mL/min
h) Nomal ECG
7) ECOG performance status (P.S.): 0 and 1.
8) No previous treatments for breast cancer.
9) Written informed consent.

Key exclusion criteria

1) Prior chemotherapy or endocrine therapy in the past 5 years.
2) Active double cancer.
3) Synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS).
4) Male patient.
5) Infection or suspected infection.
6) Serious cardiac disorder or preexisting cardiac disease.
7) Uncontrolled diabetes.
8) Gastrointestinal ulceration or gastrointestinal bleeding.
9) Other serious complication.
10) History of drug-hypersensitivity
11) Ineligible based on decision of an investigator.

Target sample size

Research contact person

Name of lead principal investigator

1st name

Middle name

Last name Norikazu Masuda

Organization

Osaka National Hospital

Division name

Department of breast surgery

Zip code

Address

1-14, 2-chome Hoenzaka, Chuo-ku, Osaka-city, Osaka 5400006, Japan

TEL

+81-6-6942-1331

Email

nmasuda@alpha.ocn.ne.jp

Public contact

Name of contact person

1st name

Middle name

Last name Katsumasa Kuroi

Organization

Japan Breast Cancer Research Group (JBCRG)

Division name

Administrative office

Zip code

Address

9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan

TEL

+81-3-6264-8873

Homepage URL

http://www.jbcrg.jp/

Email

office@jbcrg.jp

Sponsor or person

Institute

Japan Breast Cancer Research Group (JBCRG)

Institute

Department

Personal name

Funding Source

Organization

Japan Breast Cancer Research Group (JBCRG)
Bristol-Myers Squibb

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Address

Tel

Email

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪医療センター(大阪府)、虎の門病院(東京都)、大阪労災病院(大阪府)、八尾市立病院(大阪府)、広島市民病院(広島県)、群馬県立がんセンター(群馬県)

Other administrative information

Date of disclosure of the study information

2010 Year 05 Month 10 Day

Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi

Publication of results

Published

Result

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results:
pCR was achieved after mPCX and FEC by 47.5 % (19/40) of patients in the ITT population and in 54.5% (18/33) of patients in the PPS.
The clinical response rate was 90.0% (36/40) in the ITT population and 93.9% (31/33) in the PPS.
Breast conservation surgery was possible in six patients (40%) who were scheduled to undergo total mastectomy.

Conclusion:
Metronomic PCX followed by FEC
chemotherapy was associated with a high pCR rate and low toxicity in patients with TNBC.

Results date posted

2021 Year 08 Month 18 Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2014 Year 05 Month 29 Day

Baseline Characteristics

Triple-negative or low hormone receptor expressing/HER2-negative primary breast cancer

Participant flow

Metronomic PCX followed by FEC as
preoperative chemotherapy was conducted.

Adverse events

Grade 3 or higher hematologic adverse events:
Leukopenia 25% (10/40), neutropenia 35% (14/40), anemia 5% (2/40)

Outcome measures

Primary endpoint: pCR rate
Secondary endpoints:
Clinical responses, Safety,
Breast-conserving surgery rate.

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Completed

Date of protocol fixation

2010 Year 04 Month 10 Day

Date of IRB

Anticipated trial start date

2010 Year 04 Month 10 Day

Last follow-up date

2016 Year 12 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

2010 Year 05 Month 06 Day

Last modified on

2021 Year 08 Month 18 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004273

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name