UMIN-CTR Clinical Trial

Public title

A randomized study of Docetaxel + Cyclophosphamide (TC), 5-fluorouracil + Epirubicin + Cyclophosphamide (FEC)-TC and TC-FEC as preoperative chemotherapy for hormone receptor positive and HER2 negative primary breast cancer
JBCRG-09

Acronym

JBCRG-09

Scientific Title

A randomized study of Docetaxel + Cyclophosphamide (TC), 5-fluorouracil + Epirubicin + Cyclophosphamide (FEC)-TC and TC-FEC as preoperative chemotherapy for hormone receptor positive and HER2 negative primary breast cancer
JBCRG-09

Scientific Title:Acronym

JBCRG-09

Region

Japan

Condition

hormone receptor positive and HER2 negative primary breast cancer

Classification by specialty

Hematology and clinical oncology	Surgery in general	Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy and safety of 6 cycles of docetaxel and cyclophosphamide (TC), 3 cycles of 5-fluorouracil, epirubicin and cyclophosphamide (FEC) followed by 3 cycles of TC (FEC-TC), and 3 cycles of TC followed by 3 cycles of FEC as preoperative chemotherapy in patients with hormone receptor positive and HER2 negative primary breast cancer randomized to receive either of these therapies

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II

Primary outcomes

pathological complete rseponse rate

Key secondary outcomes

Safety,Overall response rate,Disease-free survival,Overall surviva, Clinical response evaluation using various diagnostic imaging techniques

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

Concealment

Central registration

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

1)TC therapy group:
6 cycles of TC therapy

TC therapy
Docetaxel : 75 mg/m2, 1h, day1
Cyclophosphamide : 600 mg/m2, 15-30min, day1

Interventions/Control_2

2)FEC-TC therapy group:
3 cycles of FEC therapy
followed by 3 cycles of TC therapy

FEC therapy group
Fluorouracil(5-FU) : 500 mg/m2, 15-30min, day1
Epirubicin (EPI) : 100 mg/m2, 5min, day1
Cyclophosphamide : 500 mg/m2, 15-30min, day1

Interventions/Control_3

3)TC-FEC therapy group:
3 cycles of TC therapy
followed by 3 cycles of FEC therapy

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

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 invasive breast cancer by needle biopsy or tissue biopsy.
2)Resectable primary breast cancer (T1c-3 N0-1 M0) and tumor size is 7 cm or smaller. Multiple ipsilateral breast cancer is eligible when at least 1 lesion meets the eligible criteria. However, each lesion has to be histologically evaluated.
3)Status of ER and PgR are confirmed by immunohistochemical staining, and Estorogen receptor(ER) and/or Progesterone receptor(PgR) positive.
4)HER2 expression is confirmed by Immunohistochemistry (IHC or FISH); and IHC=0-1+, OR if IHC 2+ -> FISH negative.
5)Age between 20 years old and 70 years old
6)Performance status (PS) 0-1.
7)Results from a laboratory test meet the following
(within 14days before registration):
Leukocyte count is >=4000/mm3 and <=12 000/mm3 or neutrophil count is >=2000/mm3
Hemoglobin >=9.0g/dL
Platelet >=100,000/mm3
AST and ALT <=x 2.5 of upper limit of normal (ULN)
total bilirubin or direct bilirubin <=ULN
Serum creatinine <=x 1.5 of ULN
8) Left ventricular ejection fraction (LVEF) is >=55% measured by echocardiography or MUGA scan.
9)No clinical abnormality by electrocardiography
10)No interstitial pneumonia or pulmonary fibrosis diagnosed by chest CT scan.
11)Evaluate images of the primary lesion before and after treatment by CT, MRI or ultrasound. The evaluation must be based on the same modality.
12)No previous treatments for breast cancer such as chemotherapy, hormone therapy, molecular target therapy, radiotherapy and immunotherapy.
13)Considered eligible to neoadjuvant chemotherapy based on decision of the attending physician after considering other treatments such as surgery, chemotherapy, hormone therapy.
14)Urinary or serum HCG negative when menopause is not confirmed (excluding patients underwent ovariectomy or hysterectomy).
15)Signed written informed consent

Key exclusion criteria

1)Hypersensitivity to any agents necessary in the planned treatment.
2)Poorly controlled complication (malignant hypertension, myocardial infarction within 6 months, congestive heart failure, coronary insufficiency, arrhythmia which requires treatment, infection and bleeding).
3)Fever with suspected infection.
4)Symptoms of varicella.
5)Pleural effusion or cardiac effusion which requires treatment.
6)Serious edema.
7)Serious peripheral neuropathy
8)Complication which requires prior treatment with corticosteroid.
9)Regular use of H2 blocker.
10)Has history of or receiving treatment for serious psychiatric disorder case.
11)Synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS).
12)History of invasive breast cancer.
13)Multiple primary cancer .However, carcinoma in situ can be cured by local treatment is not included in multiple primary cancer.
14)History of multiple primary cancers in the past 5 years, excluding nonmelanoma skin cancer, cervical cancer, thyroid cancer, early gastric cancer and early colorectal cancer appropriately treated.
15)Prior treatment with anticancer case.
16)Women who are pregnant, lactating or with childbearing potential.
17)Ineligible based on decision of an investigator.

Target sample size

195

Name of lead principal investigator

1st name	1)Masakazu 2)Norikazu
Middle name
Last name	1)Toi 2)Masuda

Organization

1)Kyoto University Hospital 2)Osaka National Hospital

Division name

1)Breast Surgery 2)Department of Surgery (mastology)

Zip code

540-0006

Address

1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka

TEL

06-6942-1331

Email

nmasuda@alpha.ocn.ne.jp

Name of contact person

1st name	Katsumasa
Middle name
Last name	Kuroi

Organization

Japan Breast Cancer Research Group (JBCRG)

Division name

Adminstrative office

Zip code

103-0016

Address

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

TEL

03-6264-8873

Homepage URL

https://www.jbcrg.jp/

Email

office@jbcrg.jp

Institute

Japan Breast Cancer Research Group (JBCRG)

Institute

Department

Personal name

Organization

Japan Breast Cancer Research Group (JBCRG)

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

JAPAN

Co-sponsor

Name of secondary funder(s)

Organization

JBCRG

Address

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

Tel

03-6264-8873

Email

office@jbcrg.jp

Secondary IDs

NO

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)
熊本大学医学部附属病院(熊本県）
群馬県立がんセンター(群馬県）
八尾市立病院(大阪府)
北海道がんセンター(北海道）
大阪労災病院(大阪府）
新潟県立がんセンター(新潟県）
虎の門病院(東京都）
広島大学病院(広島県）
杏林大学医学部附属病院（東京都）
小牧市民病院（愛知県）
兵庫医科大学(兵庫県）
大阪市立大学（大阪府）
及川病院(福岡県）
広島市民病院(広島県）
京都大学医学部附属病院(京都府)
中頭病院（沖縄県）
横浜旭中央総合病院(神奈川県）
九州がんセンター(福岡県）
長崎医療センター（長崎県）

Date of disclosure of the study information

2010

Year

03

Month

03

Day

URL releasing protocol

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

Publication of results

Published

URL related to results and publications

NA

Number of participants that the trial has enrolled

195

Results

pCR (CpCR + ypN0) rates were 9.2%, 8.1%, and 15.9% in the FEC-TC, TC-FEC, and TC6 groups, respectively. ORRs were 72.8% in the FEC-TC group (CR 12.3%), 73.0% in the TCFEC group (CR 4.8%), and 75.4% in the TC6 group (CR15.4%).
pCR rates in the three groups were similar, but the breast conservation rate was significantly higher in the TC6 group than in the others.

Results date posted

2021

Year

08

Month

18

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2020

Year

03

Month

13

Day

Baseline Characteristics

Hormone receptor-positive
HER2-negative primary breast cancer

Participant flow

Patients were randomized to receive 6 cycles of TC (TC6), 3 cycles of FEC followed by 3 cycles of TC (FEC-TC), or 3 cycles of TC followed by 3 cycles of FEC (TC-FEC).

Adverse events

AEs of grade 3 or higher were 20.0%, 27.0%, and 20.3% in the FEC-TC, TC-FEC, and TC6 groups (p =0.569).

Outcome measures

Primary endpoint: pCR rate
Secondary endpoint: Clinical responses, Safety

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2009

Year

08

Month

07

Day

Date of IRB

2009

Year

10

Month

08

Day

Anticipated trial start date

2009

Year

10

Month

09

Day

Last follow-up date

2017

Year

05

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2010

Year

03

Month

02

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=R000003873