UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007510 |
|---|---|
| Receipt number | R000008864 |
| Scientific Title | A phase 2 study of weekly Nab-Paclitaxel followed by FEC (Fluorouracil, Epirubicin, Cyclophosphamide) as primary therapy for operable breast cancer |
| Date of disclosure of the study information | 2012/03/16 |
| Last modified on | 2012/12/26 15:18:53 |
* 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 2 study of weekly Nab-Paclitaxel followed by FEC (Fluorouracil, Epirubicin, Cyclophosphamide) as primary therapy for operable breast cancer
Acronym
A phase 2 study of weekly Nab-Paclitaxel followed by FEC as primary therapy for operable breast cancer
Scientific Title
A phase 2 study of weekly Nab-Paclitaxel followed by FEC (Fluorouracil, Epirubicin, Cyclophosphamide) as primary therapy for operable breast cancer
Scientific Title:Acronym
A phase 2 study of weekly Nab-Paclitaxel followed by FEC as primary therapy for operable breast cancer
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the efficacy as measured by the pathological complete response (pCR) rate of weekly Nab-paclitaxel followed by FEC for the treatment of operable breast cancer.
Basic objectives2
Others
Basic objectives -Others
Efficacy and safety as measured by the pCR rate for each biological subtype of breast cancer, breast conservation rate, and rate of adverse effects.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Pathological complete response rate.
Key secondary outcomes
Pathological complete response rate by breast cancer subtype,
breast conservation rate,
frequency of adverse effects.
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
Four courses of weekly Nab-pacltaxel is followed by 4 courses of FEC100.
[Weekly Nab-paclitaxel]
Nab-paclitaxel at a dose of 100mg/m2 is administered on days 1, 8, and 15, of a 28 day cycle, for 4 cycles.
[FEC100]
Fluorouracil at a dose of 500 mg/m2, Epirubicin 100 mg/m2, and Cyclophosphamide 500 mg/m2 respectively, are administered on day 1 of a 21 day cycle, for 4 cycles.
* For HER2 over-expressed cases, trastuzumab is administered weekly during the Nab-paclitaxel phase concurrently.
* For hormone responsive cases, LH-RH angonist and/or aromatase inhibitor use is permitted.
Operation is to be performed within 8 weeks of the last chemotherapy day.
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. Pathologically confirmed primary breast cancer.
2. Age 20 or over.
3. Clinical T1-3, N0-2, M0 cases.
4. Curative by primary chemotherapy and surgery.
5. Performance status (ECOG) 0 or 1.
6. Has measurable lesion.
7. With no prior surgery, radiation, chemotherapy, nor hormonal therapy.
8. The below criteria met within 14 days prior to therapy;
(1) WBC between 4,000/mm3 and 12,000/mm3.
(2) Granulocyte count 2,000/mm3 or over.
(3) Platelet count 100,000/mm3 or over.
(4) Hb 9.0 g/dl or over.
(5) Serum total bilirubin 1.5 mg/dL or under.
(6) AST and ALT below 2.5 times the institute upper limit.
(7) Serum creatinine 1.5 mg/dL or under.
(8) Cardiac function: left ventricle ejection fraction 55 % or over by cardiac sonography or MUGA scan.
(9) EKG within normal limits.
9. Written consent obtained from the patient.
Key exclusion criteria
1. Cases with prior history of hypersensitivity reaction to the drugs or solvents (e.g. albumin, paclitaxel) used in this protocol.
2. Bilateral breast cancer cases.
3. Cases with inflammatory breast cancer.
4. Male breast cancer cases.
5. Cases with active secondary malignancy (current secondary malignancy or other malignancy within 5 years) .
6. Cases with conditions with the potential to compromise the planned treatment, such as cases with active infection, diarrhea, intestinal paralysis, intestinal obstruction, uncontrolled diabetes, uncontrolled angina and myocardial infarction within 6 months, heart failure, and other serious conditions.
7. Pregnant or breast feeding cases.
8. Cases with pulmonary fibrosis or interstitial pneumonia.
9. Cases with severe myelodepression, renal or liver dysfunction.
10. Cases in which the treating physician deems inappropriate to be entered into this study for other reasons.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Kamada |
Organization
Nahanishi Clinic
Division name
Division of Surgery
Zip code
Address
2-1-9 Akamine, Naha, Okinawa, Japan
TEL
098-858-5557
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobumitsu Tamaki |
Organization
Nahanishi Clinic
Division name
Division of Surgery
Zip code
Address
2-1-9 Akamine, Naha, Okinawa, Japan
TEL
98-858-5557
Homepage URL
Sponsor or person
Institute
Nahanishi Clinic
Institute
Department
Personal name
Funding Source
Organization
Nahanishi Clinic
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | Month | 16 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 02 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 03 | Month | 15 | Day |
Last modified on
| 2012 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008864
