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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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/
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004273
