UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018383 |
|---|---|
| Receipt number | R000021216 |
| Scientific Title | A Phase Ib study of Trastuzumab emtansine plus S-1 or Capecitabine in patients with previously trastuzumab treated metastatic breast cancer |
| Date of disclosure of the study information | 2015/07/23 |
| Last modified on | 2018/01/23 14:04:28 |
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Basic information
Public title
A Phase Ib study of Trastuzumab emtansine plus S-1 or Capecitabine in patients with previously trastuzumab treated metastatic breast cancer
Acronym
A Phase Ib study of Trastuzumab emtansine plus S-1 or Capecitabine in patients with previously trastuzumab treated metastatic breast cancer(MARIA15-01)
Scientific Title
A Phase Ib study of Trastuzumab emtansine plus S-1 or Capecitabine in patients with previously trastuzumab treated metastatic breast cancer
Scientific Title:Acronym
A Phase Ib study of Trastuzumab emtansine plus S-1 or Capecitabine in patients with previously trastuzumab treated metastatic breast cancer(MARIA15-01)
Region
| Japan |
Condition
Condition
Patients with HER2-positive metastatic breast cancer that has progressed on trastuzumab
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate tolerability and safety of trastuzumab emtansine plus S-1 or Capecitabine in patients with previously trastuzumab treated metastatic breast cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
Proportion of dose limiting toxicity in each dose level at completion of first cycle
Key secondary outcomes
Incidence of adverse events
Response rate (RR)
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
Cohort A
T-DM1:day1(d.i.v)
S-1:day1-day15(p.o.)
Administrated every 3weeks
Starting dose is level 0
Level 0
T-DM1:3.6mg/kg
S-1:65mg/m2/day
Level 1
T-DM1:3.6mg/kg
S-1:80mg/m2/day
CohortB
T-DM1:day1(d.i.v)
Capesitabine:day1-day15(p.o.)
Administrated every 3weeks
Starting dose is level 0
Level 0
T-DM1:3.6mg/kg
Capesitabine:1300mg/m2/day
Level 1
T-DM1:3.6mg/kg
Capesitabine:1400mg/m2/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
| Not applicable |
Gender
Female
Key inclusion criteria
1. Histopathologically proven diagnosis of breast cancer.
2. Unresectable or metastatic breast cancer
3. Age at consent is >= 20
4. ECOG PS 0-2
5. One or more measurable lesion
6. HER2 positive tumor, defined as either IHC3+ alone or IHC 2+ in combination with FISH+.
7. Patients who received at least single administration of trastuzumab for neo-adjuvant, adjuvant or chemotherapy for metastatic breast cancer (History of administration of T-DM1 is also eligible).
8. Vital organ functions (listed below) are preserved within 14 days prior to entry.
Neu. >= 1,500/cubicmillimeter
Hb. >= 9.0 g/dL
Plt. >= 100,000/cubicmillimeter
T-bil. <= 1.5 mg/dL
AST(GOT) <= 100 IU/L (<= 150 IU/L in case of liver metastasis)
ALT(GPT) <= 100 IU/L (<= 150 IU/L in case of liver metastasis)
Serum albumin >=2.5g/dL
Serum creatinine <=1.5mg/dL
Creatinine clearance >=50mL/minutes
9. Patients who is not received RBC transfusion before 14 days prior to entry
10. Women of childbearing potential (underwent menstruation within 1 year prior entry) should take a pregnancy test and give proof negative 14 days prior entry.
11. Residual <= Grade 1 per CTCAE v4.0 toxicity resulting previous therapy (e.g. chemotherapy, radiation, surgery). Alopecia, peripheral neuropathy, skin hyperpigmentation, dysgeusia is permitted.
12. Ability of oral administration.
13. Signed informed consent document
Key exclusion criteria
1. Prior treatment with chemotherapy (including trastuzumab, T-DM1), hormone therapy, immune therapy or biologics with in 14 days prior to entry.
2. Invasive surgery within 28 days prior to enrollment.
3. Documented history of congestive heart failure of any New York Herat Association (NYHA) class II-IV, or >= grade 3 heart failure per CTCAE v4.0
4. Diagnosis as angina pectoris requiring treatment within 6 months prior entry.
5. Uncontrollable hypertension (not controlled by medication systolic blood pressure <150 mmHg and diastolic blood pressure <100 mmHg)
6. Baseline LVEF <50%
7. History of exposure to cumulative doses of anthracyclines (e.g. Doxorubicin>500mg/m2, Epirubicin>720 mg/m2).
8. History of >=Grade3 infusion reaction caused by Trastuzmab or T-DM1.
9. History of discontinue trastuzumab or T-DM1 reason for adverse event.
10. Not tolerable to S-1 or Capecitabine in prior therapy
11. History of intolerance to Trastuzumab added substance (e.g. sodium succinate, sucrose, polusorbate).
12. Patients who needs continuous administration of flucytosine, phenytoin, or warfarin potassium.
13. Patients have symptomatic or periodical medication for brain metastasis
14. >=grade 2 peripheral neuropathy.
15. Hyper sensitivity to fuluoropyrimidine or known dihydropyrimidine dehydrogenase (DPD) deficiency.
16. Current known viral hepatitis.
17. Active carcinoma affect to prognosis.
18. Congenial hemorrhage or clotting abnormality
19. Current serious, uncontrolled infection or current known HIV infection.
20. Any patient unwilling or unable to use adequate contraceptive measures during study treatment and for 7 months after the last dose of study treatment.
21. Any other condition, which in the opinion of the investigator or sub-investigator would preclude participation in the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichiro Tsugawa |
Organization
St Marianna University School of Medicine
Division name
Division of Breast and Endocrine Surgery, Department of Surgery
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
koitsuga@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Kojima |
Organization
St Marianna University School of Medicine
Division name
Division of Breast and Endocrine Surgery, Department of Surgery
Zip code
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
044-977-8111
Homepage URL
kojiyasu@marianna-u.ac.jp
Sponsor or person
Institute
St Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
CHUGAI PHARMACEUTICAL CO., LTD
Organization
Division
Category of Funding Organization
Profit organization
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
| 2015 | Year | 07 | Month | 23 | 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
| 2015 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2017 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 12 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 22 | Day |
Last modified on
| 2018 | Year | 01 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021216
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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