UMIN-CTR Clinical Trial

Basic information
Public title	A study evaluating the pregnancy outcomes and safety of interrupting endocrine therapy for young women with endocrine responsive breast cancer who desire pregnancy (POSITIVE)
Acronym	JBCRG-23(POSITIVE)
Scientific Title	A study evaluating the pregnancy outcomes and safety of interrupting endocrine therapy for young women with endocrine responsive breast cancer who desire pregnancy (POSITIVE)
Scientific Title:Acronym	JBCRG-23(POSITIVE)
Region	Japan Asia(except Japan) North America Australia Europe

Condition
Condition	Premenopausal endocrine responsive early breast cancer
Classification by specialty	Breast surgery Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To assess the risk of breast cancer relapse associated with temporary interruption of endocrine therapy (ET) to permit pregnancy.
Basic objectives2	Others
Basic objectives -Others	To evaluate factors associated with pregnancy success after interruption of endocrine therapy.
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Breast Cancer free interval (BCFI) defined as the time from enrollment in the study to the first invasive BC event (local, regional, or distant recurrence or a new invasive contralateral BC).
Key secondary outcomes	-Menstruation recovery and pattern. -Pregnancy (determined by pregnancy test). -Pregnancy outcome: full term pregnancy, caesarean section, abortion, miscarriage, ectopic, stillbirth. -Offspring outcome: preterm birth, low birth weight, birth defects. -Breastfeeding; pattern of breastfeeding (duration, use ipsilateral breast if previous breast conservation, side exclusivity). -Use of assisted reproductive technology (ART). -Adherence to endocrine treatment assessed by: -- Treatment resumption after the ~2 year ET break. -- Total duration of at least 5 years of ET. -Distant recurrence-free interval (DRFI), defined as the time from enrollment in the study to the first BC recurrence in a distant site, excluding second (non-breast) primary cancers and contralateral breast cancer.

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	Behavior,custom
Interventions/Control_1	Endocrine therapy interruption after having completed between >= 18 months and <= 30 months 3 months wash-out between treatment interruption and pregnancy attempt Up to 2 years interruption to allow pregnancy, delivery, breastfeeding or failure to conceive Endocrine therapy resumption Completion of full duration of endocrine therapy according to individual risk, institutional policy or patient's preference
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	18 years-old <=
Age-upper limit	42 years-old >=
Gender	Female
Key inclusion criteria	-Has received adjuvant endocrine therapy (SERM alone, GnRH analogue plus SERM or AI) for >= 18 months but <= 30 months for early breast cancer. -The adjuvant endocrine therapy must have stopped within 1 month prior to enrollment. -Patient wishes to become pregnant. -Breast cancer for which patient is receiving endocrine therapy must have been histologically-proven stage I-III, endocrine-responsive (i.e., estrogen and/or progesterone receptor positive, according to local definition of positive, determined using immunohistochemistry (IHC)), and treated with curative intent. -Patient must be premenopausal at breast cancer diagnosis, as determined locally and documented in patient record. -Patient must be without clinical evidence of loco-regional and distant disease, as evaluated according to institutional assessment standards and documented in the patient record. -Written informed consent (IC) for trial participation must be signed and dated by the patient and the investigator prior to enrollment. -Written consent to biological material submission, indicating the patient has been informed of and agrees to tissue and blood material use, transfer and handling, must be signed and dated by the patient and the investigator prior to any procedures specific for this trial. -The patient has been informed of and agrees to data transfer and handling, in accordance with national data protection guidelines. -Patient must be accessible for follow-up.
Key exclusion criteria	-Post-menopausal patients at BC diagnosis, as determined locally. -History of hysterectomy, bilateral oophorectomy or ovarian irradiation. -Patients with current local, loco-regional relapse and/or distant metastatic breast cancer. -Patients with a history of prior (ipsi- and/or contralateral) invasive BC. -Patients with previous or concomitant non-breast invasive malignancy. -Exceptions are limited exclusively to patients with the following previous malignancies, if adequately treated: basal or squamous cell carcinoma of the skin, in situ non-breast carcinoma, contra- or ipsilateral in situ breast carcinoma, stage Ia carcinoma of the cervix. -Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical disorder that would interfere with the patient's safety. -Patients with a history of noncompliance to medical treatments and/or considered potentially unreliable. -Patients with psychiatric, addictive, or any disorder that would prevent compliance with protocol requirements.
Target sample size	500

Research contact person
Name of lead principal investigator	1st name Olivia Middle name Last name Pagani
Organization	Oncology Institue of Southern Switzerland (IOSI)
Division name	-
Zip code	6500
Address	Ospedale Regionale Bellinzona e Valli - 6500 Bellinzona
TEL	+41-91-811-8435
Email	olivia.pagani@ibcsg.org

Public contact
Name of contact person	1st name Jun Middle name Last name Fukase
Organization	JBCRG (Japan Breast Cancer Research Group)
Division name	Head office
Zip code	103-0016
Address	9-4-3F Nihonbashi koamicho, Chuo-ku, Tokyo
TEL	03-6264-8873
Homepage URL
Email	office@jbcrg.jp

Sponsor
Institute	International Breast Cancer Study Group (IBCSG)
Institute
Department

Funding Source
Organization	International Breast Cancer Study Group (IBCSG)
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization	Switzerland

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	N/A
Address	N/A
Tel	N/A
Email	N/A

Secondary IDs
Secondary IDs	YES
Study ID_1	IBCSG 48-14
Org. issuing International ID_1	International Breast Cancer Study Group (IBCSG)
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	国立がん研究センター 中央病院(東京)、がん研　有明病院(東京)、関西ろうさい病院(大阪)、岡山大学病院(岡山)、九州がんセンター(福岡)、虎の門病院(東京)、筑波大学附属病院(茨城)、昭和大学病院(東京)、聖路加国際病院(東京)、聖マリアンナ医科大学病院(神奈川)、国立病院機構　大阪医療センター(大阪)、京都大学医学部附属病院(京都)、博愛会　相良病院(鹿児島)、聖隷浜松病院(静岡)、国立病院機構 四国がんセンター(愛媛)、東北大学病院(宮城)、国立国際医療研究センター(東京）

Other administrative information
Date of disclosure of the study information	2015 Year 12 Month 02 Day

Related information
URL releasing protocol	http://www.ibcsg.org/Member/Clinical_Trials/Open_Trials/ibcsg_48-14_positive/Pages/
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	No longer recruiting
Date of protocol fixation	2014 Year 06 Month 13 Day
Date of IRB	2015 Year 11 Month 26 Day
Anticipated trial start date	2016 Year 03 Month 11 Day
Last follow-up date	2020 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 11 Month 25 Day
Last modified on	2021 Year 08 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022962