UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008085 |
|---|---|
| Receipt number | R000009512 |
| Scientific Title | A Phase II study of Neoadjuvant chemotherapy in Tri-weekly nab-Paclitaxel followed by FEC with Operable HER2 Negative breast cancer |
| Date of disclosure of the study information | 2012/06/01 |
| Last modified on | 2019/03/22 16:15:12 |
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Basic information
Public title
A Phase II study of Neoadjuvant chemotherapy in Tri-weekly nab-Paclitaxel followed by FEC with Operable HER2 Negative breast cancer
Acronym
KBCSG-TR1213
Scientific Title
A Phase II study of Neoadjuvant chemotherapy in Tri-weekly nab-Paclitaxel followed by FEC with Operable HER2 Negative breast cancer
Scientific Title:Acronym
KBCSG-TR1213
Region
| Japan |
Condition
Condition
HER2 negative operable breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of preoperative administration of Tri-weekly nanoparticle albumin-bound paclitaxel (nab-Paclitaxel) of 4 cycles followed by FEC of 4 cycles in patients with HER2 negative operable breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Pathological complete response rate
Key secondary outcomes
(1) Safety (adverse events, incidence of cardiac disorders)
(2) Overall response rate
(3) Breast conserving rate
(4) QpCR rate
(5) CpCR and pN0 rate
(6) SpCR rate
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administrate 4 cycles of FEC after 4 cycles of nab-Paclitaxel. Operation is to be performed after chemotherapy.
nab-Paclitaxel 4 cycles
nab-Paclitaxel 260mg/m2 iv day1 q3w
FEC 4 cycles
5-Fluorouracil 500mg/m2 iv day 1 q3w
Epirubicin 100mg/m2 iv day 1 q3w
Cyclophosphamide 500mg/m2 iv day 1 q3w
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
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
1) Primary breast cancer patients who are diagnosed as invasive breast cancer by needle biopsy or tissue biopsy.
2) T1c-3, N0-1, M0 and tumor size is less than 7 cm.
3) Invasive lesion of the primary lesion is confirmed as HER2 negative (IHC 0-1+ or, if IHC 2+ -> FISH negative).
4) Enrollmental age between 20 years old and 65 years old.
5) ECOG performance status (PS):0-1
6) Results from a laboratory test meet the following :
- Neutrophil count is >= 1,500/mm3
- Platelet >= 100,000/mm3
- Hemoglobin >= 10.0 g/dL
- AST <= 3 times of upper limit of normal (ULN)
- ALT <= 3 times of upper limit of normal (ULN)
- Total bilirubin < 1.5 mg/dL
- Creatinine < 1.5 mg/dL
7) No clinical abnormality by electrocardiography.
8) No interstitial pneumonia and pulmonary fibrosis diagnosed by chest X-rays or CT scan.
9) Evaluate images of the primary lesion before and after treatment by CT, MRI. The evaluation must be conducted by the same modality (At an allergy for contrast media, the omission is permissible).
10) No previous treatments for breast cancer such as chemotherapy, hormone therapy, molecular target therapy, radiotherapy and immunotherapy.
11) Considered eligible to neoadjuvant chemotherapy based on decision of the attending physician after considering other treatments such as surgery, chemotherapy, hormone therapy, radiation therapy.
12) Urinary or serum HCG negative when menopause is not confirmed (excluding patients underwent ovariectomy or hysterectomy).
13) Signed written informed consent.
Key exclusion criteria
1) Hypersensitivity to any agents necessary in the planned treatment.
2) Poorly controlled complication.
3) Active infectious disease or Fever with suspected infection.
4) Symptoms of varicella.
5) Serious edema.
6) Serious peripheral neuropathy.
7) Positive for HBs antigen.
8) Complication which requires prior pre-treatment with corticosteroid.
9) Previous history or receiving treatment of dementia or serious psychiatric disorder.
10) Heterochrony or synchronous bilateral breast cancer excluding contralateral non-invasive cancer (DCIS/LCIS).
11) Active multiple cancer (Non-invasive tumor or disease free periods after treatment are more than two years, considered to be non-activity).
12) Prior treatment with anticancer agents.
13) Ineligible based on decision of an investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norikazu Masuda |
Organization
Osaka National Hospital
Division name
Department of Surgery (mastology)
Zip code
Address
1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka
TEL
0669421331
nmasuda@alpha.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norikazu Masuda |
Organization
Kinki Breast Cancer Study Group-Translational Research (KBCSG-TR)
Division name
Adminstrative office
Zip code
Address
1-14, 2-chome Hoenzaka, chuou-ku, Osaka-city, Osaka
TEL
06-6942-1331
Homepage URL
nmasuda@alpha.ocn.ne.jp
Sponsor or person
Institute
Kinki Breast Cancer Study Group-Translational Research (KBCSG-TR)
Institute
Department
Personal name
Funding Source
Organization
The Supporting Center for Clinical Research and Education (SCCRE)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
None
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
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
| 2012 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2012 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2012 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 06 | Month | 01 | Day |
Last modified on
| 2019 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009512
