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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001298
Receipt No. 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

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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 &#61619;3000/mm3 or neutrophil count &#61619;1500/mm3
2) Hemoglobin &#61619;9.0 g/dL
3) Platelet count &#61619;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 &#61619;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&#61650;) (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
Email

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/
Email toshikai@sbccsg.org

Sponsor
Institute Saitama Breast Cancer Clinical Study Group (SBCCSG)
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001577

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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