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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02308085
Registration number
NCT02308085
Ethics application status
Date submitted
21/11/2014
Date registered
4/12/2014
Date last updated
23/04/2024
Titles & IDs
Public title
Pregnancy Outcome and Safety of Interrupting Therapy for Women With Endocrine Responsive Breast Cancer
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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
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Secondary ID [1]
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Alliance A221405
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Secondary ID [2]
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IBCSG 48-14 / BIG 8-13
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Universal Trial Number (UTN)
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Trial acronym
POSITIVE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Early Breast Cancer
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Condition category
Condition code
Cancer
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0
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Breast
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Endocrine therapy interruption
Experimental: Endocrine therapy interruption - Endocrine therapy interruption after having completed between = 18 months and = 30 months.
Other interventions: Endocrine therapy interruption
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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Breast Cancer free interval (BCFI)
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Assessment method [1]
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Kaplan-Meier Analysis
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Timepoint [1]
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From enrollment until the first invasive BC event, assessed up to 14 years
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Secondary outcome [1]
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Information on Menstruation recovery and pattern
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Assessment method [1]
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Menstrual diary
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Timepoint [1]
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Up to 24 months after enrollment
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Secondary outcome [2]
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Pregnancy rate (determined by pregnancy test)
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Assessment method [2]
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Pregnancy test
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Timepoint [2]
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Up to 24 months after enrollment
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Secondary outcome [3]
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Pregnancy outcome
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Assessment method [3]
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Labor and delivery Information, full term pregnancy, caesarean section, abortion, miscarriage, ectopic, stillbirth rates.
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Timepoint [3]
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Up to 33 months after enrollment
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Secondary outcome [4]
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Offspring outcome
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Assessment method [4]
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Collect information on preterm birth, low birth weight, births defects rates.
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Timepoint [4]
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Up to 33 months after enrollment
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Secondary outcome [5]
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Breastfeeding pattern
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Assessment method [5]
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Analysis of pattern e.g Duration, use of ipsilateral breast if previous breast conservation, side exclusivity
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Timepoint [5]
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Up to 36 months after enrollment
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Secondary outcome [6]
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Use of assisted reproductive Technology (ART)
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Assessment method [6]
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ART use will be tabulated
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Timepoint [6]
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Up to 24 months after enrollment
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Secondary outcome [7]
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Distant recurrence-free interval (DRFI)
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Assessment method [7]
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Kaplan-Meier Analysis
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Timepoint [7]
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Time from enrollment in the study to the first breast cancer recurrence in a distant site, assessed up to 14 years
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Eligibility
Key inclusion criteria
* Age = 18 and = 42 years at enrollment.
* Has received adjuvant endocrine therapy (SERM alone, GnRH analogue plus SERM or AI) for =18 months but =30 months for early breast cancer.
Note: Patients who have received neo/adjuvant endocrine treatment within a clinical trial and patients who have received pharmaco-prevention are eligible.
* The adjuvant endocrine therapy must have stopped within 1 month prior to enrollment.
* Patient wishes to become pregnant. Note: Patients who have undergone oocyte/embryo/ovarian tissue cryopreservation at breast cancer diagnosis and/or have a previous history of assisted reproductive technology (ART) are eligible.
* 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.
Note:
* Patients with synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) are eligible.
* Patient with invasive breast cancer or synchronous bilateral invasive breast cancer (diagnosed histologically within 2 months) during pregnancy are eligible.
* Patients with BRCA1/2 mutations are eligible.
* Patients could have received neo/adjuvant chemotherapy, or other systemic therapy (e.g., neo/adjuvant HER2-targeted therapy) according to institutional policy and patient's desire.
* 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.
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Minimum age
18
Years
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Maximum age
42
Years
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Sex
Females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
NA
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/12/2014
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2028
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Actual
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Sample size
Target
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Accrual to date
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Final
518
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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St John of God Subiaco Hospital - Perth
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Recruitment postcode(s) [1]
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6008 - Perth
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
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Name
ETOP IBCSG Partners Foundation
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Other
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Alliance for Clinical Trials in Oncology
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Other
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Canadian Cancer Trials Group
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Breast International Group
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Ethics approval
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Summary
Brief summary
The best available evidence suggests that pregnancy after breast cancer does not increase a woman's risk of developing a recurrence from her breast cancer. In particular, the most recent data suggest that this is the case also in women with a hormone receptor-positive breast cancer. There is also no indication of increased risk for delivery complications or for the newborn. The aim of the study is to investigate if temporary interruption of endocrine therapy, with the goal to permit pregnancy, is associated with a higher risk of breast cancer recurrence.The study aims also to evaluate different specific indicators related to fertility, pregnancy and breast cancer biology in young women. A psycho-oncological companion study on fertility concerns, psychological well-being and decisional conflicts will be conducted in interested Centers.
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Trial website
https://clinicaltrials.gov/study/NCT02308085
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Trial related presentations / publications
Brinton LA, Sherman ME, Carreon JD, Anderson WF. Recent trends in breast cancer among younger women in the United States. J Natl Cancer Inst. 2008 Nov 19;100(22):1643-8. doi: 10.1093/jnci/djn344. Epub 2008 Nov 11. Leclere B, Molinie F, Tretarre B, Stracci F, Daubisse-Marliac L, Colonna M; GRELL Working Group. Trends in incidence of breast cancer among women under 40 in seven European countries: a GRELL cooperative study. Cancer Epidemiol. 2013 Oct;37(5):544-9. doi: 10.1016/j.canep.2013.05.001. Epub 2013 Jun 12. Erratum In: Cancer Epidemiol. 2014 Feb;38(1):106. GRELL Working Group [added]; multiple investigator names added. Bentzon N, During M, Rasmussen BB, Mouridsen H, Kroman N. Prognostic effect of estrogen receptor status across age in primary breast cancer. Int J Cancer. 2008 Mar 1;122(5):1089-94. doi: 10.1002/ijc.22892. Anders CK, Hsu DS, Broadwater G, Acharya CR, Foekens JA, Zhang Y, Wang Y, Marcom PK, Marks JR, Febbo PG, Nevins JR, Potti A, Blackwell KL. Young age at diagnosis correlates with worse prognosis and defines a subset of breast cancers with shared patterns of gene expression. J Clin Oncol. 2008 Jul 10;26(20):3324-30. doi: 10.1200/JCO.2007.14.2471. Erratum In: J Clin Oncol. 2011 Sep 20;29(27):3721. Perachino M, Poggio F, Arecco L, Blondeaux E, Spinaci S, Marrocco C, Levaggi A, Lambertini M. Update on Pregnancy Following Breast Cancer Diagnosis and Treatment. Cancer J. 2022 May-Jun 01;28(3):176-182. doi: 10.1097/PPO.0000000000000599.
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Contacts
Principal investigator
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Olivia Pagani, MD
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Oncology Institue of Southern Switzerland (IOSI)
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https://clinicaltrials.gov/study/NCT02308085
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