Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Secondary ID [1] 0 0
Alliance A221405
Secondary ID [2] 0 0
IBCSG 48-14 / BIG 8-13
Universal Trial Number (UTN)
Trial acronym
POSITIVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Early Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Breast Cancer free interval (BCFI)
Timepoint [1] 0 0
From enrollment until the first invasive BC event, assessed up to 14 years
Secondary outcome [1] 0 0
Information on Menstruation recovery and pattern
Timepoint [1] 0 0
Up to 24 months after enrollment
Secondary outcome [2] 0 0
Pregnancy rate (determined by pregnancy test)
Timepoint [2] 0 0
Up to 24 months after enrollment
Secondary outcome [3] 0 0
Pregnancy outcome
Timepoint [3] 0 0
Up to 33 months after enrollment
Secondary outcome [4] 0 0
Offspring outcome
Timepoint [4] 0 0
Up to 33 months after enrollment
Secondary outcome [5] 0 0
Breastfeeding pattern
Timepoint [5] 0 0
Up to 36 months after enrollment
Secondary outcome [6] 0 0
Use of assisted reproductive Technology (ART)
Timepoint [6] 0 0
Up to 24 months after enrollment
Secondary outcome [7] 0 0
Distant recurrence-free interval (DRFI)
Timepoint [7] 0 0
Time from enrollment in the study to the first breast cancer recurrence in a distant site, assessed up to 14 years

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.
Minimum age
18 Years
Maximum age
42 Years
Sex
Females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2028
Actual
Sample size
Target
Accrual to date
Final
518
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
St John of God Subiaco Hospital - Perth
Recruitment postcode(s) [1] 0 0
6008 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Delaware
Country [5] 0 0
United States of America
State/province [5] 0 0
District of Columbia
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Hawaii
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Massachusetts
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Minnesota
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Montana
Country [16] 0 0
United States of America
State/province [16] 0 0
New Hampshire
Country [17] 0 0
United States of America
State/province [17] 0 0
New Mexico
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
North Dakota
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
Rhode Island
Country [24] 0 0
United States of America
State/province [24] 0 0
South Carolina
Country [25] 0 0
United States of America
State/province [25] 0 0
South Dakota
Country [26] 0 0
United States of America
State/province [26] 0 0
Texas
Country [27] 0 0
United States of America
State/province [27] 0 0
Utah
Country [28] 0 0
United States of America
State/province [28] 0 0
Vermont
Country [29] 0 0
United States of America
State/province [29] 0 0
Virginia
Country [30] 0 0
United States of America
State/province [30] 0 0
Washington
Country [31] 0 0
Austria
State/province [31] 0 0
Graz
Country [32] 0 0
Austria
State/province [32] 0 0
Innsbruck
Country [33] 0 0
Austria
State/province [33] 0 0
Salzburg
Country [34] 0 0
Austria
State/province [34] 0 0
Vienna
Country [35] 0 0
Belgium
State/province [35] 0 0
Brussels
Country [36] 0 0
Belgium
State/province [36] 0 0
Leuven
Country [37] 0 0
Belgium
State/province [37] 0 0
Liege
Country [38] 0 0
Belgium
State/province [38] 0 0
Namur
Country [39] 0 0
Canada
State/province [39] 0 0
Alberta
Country [40] 0 0
Canada
State/province [40] 0 0
British Columbia
Country [41] 0 0
Canada
State/province [41] 0 0
Ontario
Country [42] 0 0
Canada
State/province [42] 0 0
Quebec
Country [43] 0 0
Denmark
State/province [43] 0 0
København
Country [44] 0 0
France
State/province [44] 0 0
Bordeaux
Country [45] 0 0
France
State/province [45] 0 0
Lille
Country [46] 0 0
France
State/province [46] 0 0
Lyon
Country [47] 0 0
France
State/province [47] 0 0
Paris
Country [48] 0 0
Greece
State/province [48] 0 0
Crete
Country [49] 0 0
Greece
State/province [49] 0 0
Athens
Country [50] 0 0
Hungary
State/province [50] 0 0
Debrecen
Country [51] 0 0
Ireland
State/province [51] 0 0
Dublin 8
Country [52] 0 0
Ireland
State/province [52] 0 0
Dublin
Country [53] 0 0
Ireland
State/province [53] 0 0
Galway
Country [54] 0 0
Ireland
State/province [54] 0 0
Limerick
Country [55] 0 0
Ireland
State/province [55] 0 0
Waterford
Country [56] 0 0
Israel
State/province [56] 0 0
Jerusalem
Country [57] 0 0
Israel
State/province [57] 0 0
Tel Hashomer
Country [58] 0 0
Italy
State/province [58] 0 0
Firenze
Country [59] 0 0
Italy
State/province [59] 0 0
Modena
Country [60] 0 0
Italy
State/province [60] 0 0
Vareze
Country [61] 0 0
Italy
State/province [61] 0 0
Aviano
Country [62] 0 0
Italy
State/province [62] 0 0
Biella
Country [63] 0 0
Italy
State/province [63] 0 0
Bolzano
Country [64] 0 0
Italy
State/province [64] 0 0
Genova
Country [65] 0 0
Italy
State/province [65] 0 0
Meldola
Country [66] 0 0
Italy
State/province [66] 0 0
Milan
Country [67] 0 0
Italy
State/province [67] 0 0
Novara
Country [68] 0 0
Italy
State/province [68] 0 0
Pavia
Country [69] 0 0
Italy
State/province [69] 0 0
Rimini
Country [70] 0 0
Italy
State/province [70] 0 0
Rome
Country [71] 0 0
Italy
State/province [71] 0 0
Trento
Country [72] 0 0
Italy
State/province [72] 0 0
Varese
Country [73] 0 0
Italy
State/province [73] 0 0
Viterbo
Country [74] 0 0
Japan
State/province [74] 0 0
Hyogo
Country [75] 0 0
Japan
State/province [75] 0 0
Shizuoka
Country [76] 0 0
Japan
State/province [76] 0 0
Fukuoka
Country [77] 0 0
Japan
State/province [77] 0 0
Kagoshima
Country [78] 0 0
Japan
State/province [78] 0 0
Kawasaki
Country [79] 0 0
Japan
State/province [79] 0 0
Kyoto
Country [80] 0 0
Japan
State/province [80] 0 0
Matsuyama
Country [81] 0 0
Japan
State/province [81] 0 0
Minato-ku, Tokyo
Country [82] 0 0
Japan
State/province [82] 0 0
Nagoya
Country [83] 0 0
Japan
State/province [83] 0 0
Okayama
Country [84] 0 0
Japan
State/province [84] 0 0
Sendai
Country [85] 0 0
Japan
State/province [85] 0 0
Tokyo
Country [86] 0 0
Japan
State/province [86] 0 0
Tsukuba
Country [87] 0 0
Japan
State/province [87] 0 0
Osaka
Country [88] 0 0
Korea, Republic of
State/province [88] 0 0
Seoul
Country [89] 0 0
Lebanon
State/province [89] 0 0
Beirut
Country [90] 0 0
Netherlands
State/province [90] 0 0
Leiden
Country [91] 0 0
Norway
State/province [91] 0 0
Oslo
Country [92] 0 0
Portugal
State/province [92] 0 0
Lisbon
Country [93] 0 0
Serbia
State/province [93] 0 0
Belgrade
Country [94] 0 0
Slovenia
State/province [94] 0 0
Ljubljana
Country [95] 0 0
Spain
State/province [95] 0 0
Murcia
Country [96] 0 0
Spain
State/province [96] 0 0
Barcelona
Country [97] 0 0
Spain
State/province [97] 0 0
Donostia
Country [98] 0 0
Spain
State/province [98] 0 0
Gerona
Country [99] 0 0
Spain
State/province [99] 0 0
Madrid
Country [100] 0 0
Spain
State/province [100] 0 0
Málaga
Country [101] 0 0
Spain
State/province [101] 0 0
Oviedo
Country [102] 0 0
Spain
State/province [102] 0 0
Palma
Country [103] 0 0
Spain
State/province [103] 0 0
Pamplona
Country [104] 0 0
Spain
State/province [104] 0 0
Santiago de Compostela
Country [105] 0 0
Spain
State/province [105] 0 0
Sevilla
Country [106] 0 0
Spain
State/province [106] 0 0
Toledo
Country [107] 0 0
Spain
State/province [107] 0 0
Valencia
Country [108] 0 0
Spain
State/province [108] 0 0
Zaragoza
Country [109] 0 0
Switzerland
State/province [109] 0 0
Bern
Country [110] 0 0
Switzerland
State/province [110] 0 0
Baden
Country [111] 0 0
Switzerland
State/province [111] 0 0
Basel
Country [112] 0 0
Switzerland
State/province [112] 0 0
Bellinzona
Country [113] 0 0
Switzerland
State/province [113] 0 0
Frauenfeld
Country [114] 0 0
Switzerland
State/province [114] 0 0
Genève
Country [115] 0 0
Switzerland
State/province [115] 0 0
Lausanne
Country [116] 0 0
Switzerland
State/province [116] 0 0
Sion
Country [117] 0 0
Switzerland
State/province [117] 0 0
St. Gallen
Country [118] 0 0
Switzerland
State/province [118] 0 0
Zurich
Country [119] 0 0
Switzerland
State/province [119] 0 0
Zürich

Funding & Sponsors
Primary sponsor type
Other
Name
ETOP IBCSG Partners Foundation
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Alliance for Clinical Trials in Oncology
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Canadian Cancer Trials Group
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Breast International Group
Address [3] 0 0
Country [3] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Olivia Pagani, MD
Address 0 0
Oncology Institue of Southern Switzerland (IOSI)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02308085