UMIN-CTR Clinical Trial

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	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)
Scientific Title:Acronym	JBCRG-13
Region	Japan

Condition
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	1
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	40

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
Institute	Japan Breast Cancer Research Group (JBCRG)
Institute
Department

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
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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	NA
Number of participants that the trial has enrolled	41
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004273