UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter pahse II trial of neoadjuvant goserelin acetate and tamoxifen treatment for premenopausal ER-positive and HER2-negative breast cancers
Acronym	ZTNeo trial
Scientific Title	Multicenter pahse II trial of neoadjuvant goserelin acetate and tamoxifen treatment for premenopausal ER-positive and HER2-negative breast cancers
Scientific Title:Acronym	ZTNeo trial
Region	Japan

Condition
Condition	Premenopausal breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Identification of efficacy of neoadjuvant goserelin acetate and tamoxifen treatment for premenopausal ER-positive and HER2-negative breast cancers.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	clinical response rate
Key secondary outcomes	Pathological response, Rate of breast conserving surgery, safety, disease free survival

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	Treatment with goserelin acetate (3.6mg, q4w) and tamoxifen (20mg/day) for 24 weeks.
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	55 years-old >=
Gender	Female
Key inclusion criteria	1. Histologically or cytologically confirmed premenopausal breast cancer (female between 20 and 55 years old) 2. Stage I-III (TNM) 3. Estrogen receptor positive (positive cells were more than 10%) 4. HER 2 negative (IHC score 0, 1 or 2 and FISH-negative) 5. Containing measurable tumor 6. PS: 0-1 (ECOG) 7. Signed written informed consent
Key exclusion criteria	1. Another cancer diagnosed within 5 years 2. Pregnant or nursing women 3. Cases who physician judged improper to entry this trial
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuo Miyoshi
Organization	Hyogo College of Medicine
Division name	Department of Breast and Endocrine Surgery
Zip code
Address	Mukogawa 1-1, Nishinomiya, Hyogo 663-8501
TEL	0798-45-6374
Email	ymiyoshi@hyo-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yasuo Miyoshi
Organization	Hyogo College of Medicine
Division name	Department of Breast and Endocrine Surgery
Zip code
Address	1-1 Mukogawa Nishinomiya
TEL	0798-45-6374
Homepage URL
Email	ymiyoshi@hyo-med.ac.jp

Sponsor
Institute	Department of Breast and Endocrine Surgery, Hyogo College of Medicine
Institute
Department

Funding Source
Organization	Department of Breast and Endocrine Surgery, Hyogo College of Medicine
Organization
Division
Category of Funding Organization	Other
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	2011 Year 12 Month 26 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	2011 Year 09 Month 01 Day
Date of IRB	2011 Year 10 Month 01 Day
Anticipated trial start date	2011 Year 12 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 12 Month 25 Day
Last modified on	2020 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008029