UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001298 |
|---|---|
| Receipt number | R000001577 |
| Scientific Title | Phase II study of exemestane with doxorubicin plus paclitaxel (AP) followed by weekly paclitaxel (wP) as primary systemic chemotherapy for hormone-sensitive and HER2-negative postmenopausal breast cancer (SBCCSG-13 EAPAC) |
| Date of disclosure of the study information | 2008/08/05 |
| Last modified on | 2018/12/18 19:55:59 |
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Basic information
Public title
Phase II study of exemestane with doxorubicin plus paclitaxel (AP) followed by weekly paclitaxel (wP) as primary systemic chemotherapy for hormone-sensitive and HER2-negative postmenopausal breast cancer (SBCCSG-13 EAPAC)
Acronym
Phase II study of exemestane with doxorubicin plus paclitaxel (AP) followed by weekly paclitaxel (wP) as primary systemic chemotherapy for hormone-sensitive and HER2-negative postmenopausal breast cancer (SBCCSG-13 EAPAC)
Scientific Title
Phase II study of exemestane with doxorubicin plus paclitaxel (AP) followed by weekly paclitaxel (wP) as primary systemic chemotherapy for hormone-sensitive and HER2-negative postmenopausal breast cancer (SBCCSG-13 EAPAC)
Scientific Title:Acronym
Phase II study of exemestane with doxorubicin plus paclitaxel (AP) followed by weekly paclitaxel (wP) as primary systemic chemotherapy for hormone-sensitive and HER2-negative postmenopausal breast cancer (SBCCSG-13 EAPAC)
Region
| Japan |
Condition
Condition
Postmenopausal breast cancer
Classification by specialty
| Endocrinology and Metabolism | Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to investigate the rate of pathologically complete response (pCR) by administering doxorubicin hydrochloride (ADM) and paclitaxel (PTX) therapy and then weekly PTX (wP) as combination preoperative chemotherapy following a stable disease (SD) effect of exemestane in patients with postmenopausal hormone-sensitive HER2-negative breast cancer, and the efficacy and safety of this treatment regimen.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Pathological response rate
Key secondary outcomes
Clinical response rate, recurrence-free survival time, total survival time, rate of occurrence of adverse events, breast-conservation rate, treatment completion rate, biomarkers
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
Exemestane (25 mg Tablet) is orally administered once a day every day. Doxorubicin plus paclitaxel (AP) followed by weekly paclitaxel (wP).
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. Patients histologically diagnosed with unilateral primary breast cancer. (Inflammatory breast cancer will be excluded.)
2. Patients whose tumor is 2 cm or more in diameter or who are axillary lymph node metastasis positive.
3. Patients whose primary lesion is immunohistochemically estrogen receptor (ER)-positive (10% or more staining) and
4. does not over-express HER2 (Herceptest score 0 or 1+, or in the case of 2+, FISH test signal ratio less than 2.0)
5. Patients who have not received endocrine therapy or chemotherapy for breast cancer
6. Patients who are menopausal and 20 to 65 years of age
7. Patients whose general condition is (ECOG Performance Status [PS]) 0 or 1
8. Patients from whom informed consent has been obtained in writing
9. Patients who have not undergone surgery
Patients whose major organ function has been maintained as indicated by the following:
1) WBC count 3000/mm3 or neutrophil count 1500/mm3
2) Hemoglobin 9.0 g/dL
3) Platelet count 100,000 mm3
4) AST and ALT No more than 2.5 times the upper limit of normal values at the institution
5) Total bilirubin 1.5 g/dL
6) ECG Normal (patients with no heart disease or serious arrhythmias)
Key exclusion criteria
1. Synchronous bilateral breast cancer
2. Patients with a serious complication
3. Patients who have a heart disease, such as ischemic heart disease, arrhythmias, etc., that require treatment (left ventricular hypertrophy associated with hypertension or mild left ventricle loading, mild right bundle branch block, etc., eligible for registration), and patients who have a history of myocardial infarction that occurred within the past 6 months
4. Patients with diabetes that is difficult to control, as a complication
5. Patients suspected of having an infection
6. Patients with a past history of serious hypersensitivity or patients with a history of hypersensitivity to the drugs used in this study or preparations containing polyoxyethylene castor oil (Cremophor EL) (cyclosporine injection, etc.)
7. Patients who are pregnant or breast feeding
8.Patients who for any other reason are judged to be unsuitable by the physician in charge
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Inoue |
Organization
Saitama Cancer Center
Division name
Breast Oncology
Zip code
Address
818 Komuro Ina Kitaadachi, Saitama 362-0806
TEL
048-722-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Kai |
Organization
Saitama Breast Cancer Clinical Study Group (SBCCSG)
Division name
Executive office(c/o: Shin-toshin Ladies MammoClinic)
Zip code
Address
3F, Capital Bldg. 4-261-1, Kishiki-cho, Omiya-ku, Saitama-City 330-0843, Saitama Prefecture
TEL
048-600-1722
Homepage URL
http://www.sbccsg.org/
toshikai@sbccsg.org
Sponsor or person
Institute
Saitama Breast Cancer Clinical Study Group (SBCCSG)
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2008 | Year | 08 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
No longer recruiting
Date of protocol fixation
| 2008 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2019 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2019 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 04 | Day |
Last modified on
| 2018 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001577
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