UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019929 |
|---|---|
| Receipt number | R000022962 |
| 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) |
| Date of disclosure of the study information | 2015/12/02 |
| Last modified on | 2021/08/26 15:21:57 |
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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 | Obstetrics 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
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
office@jbcrg.jp
Sponsor or person
Institute
International Breast Cancer Study Group (IBCSG)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022962
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| Registered date | File name |
| Research case data | |
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