Condition category
Cancer
Date applied
01/11/2019
Date assigned
06/12/2019
Last edited
09/12/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Breast cancer accounts for 1/3 of all malignant diagnosis among females world-wide and is often detected in an early stage. The 5-years survival of breast cancer is about 90%, both due to early screening detection and adjuvant therapy. Despite this, breast cancers might develop recurrence throughout the 20 years after diagnosis. For premenopausal women, breast cancer is a leading cause of death and patients are still being under- and over-treated due to imperfect models to predict outcomes. The possibility to de-escalate therapy, without detrimental effect on survival, is warranted. A majority of breast cancer tumours are sensitive to endocrine treatment, and the patients are generally recommended adjuvant endocrine therapy alone or with additional chemotherapy. Tamoxifen is the most recommended oral drug as adjuvant endocrine therapy in premenopausal women.
This study aims to analyse tissue samples taken during an earlier trial and relate their characteristics to the long-term outcomes in the patients who took part in the earlier trial

Who can participate?
Participants from the earlier SBII:2 trial (1986-1991)

What does the study involve?
Tissue samples collected during the original SBII:2 trial will be analysed and their characteristics compared to the long-term outcomes in the patients

What are the possible benefits and risks of participating?
None

Where is the study run from?
Skåne University Hospital, Sweden

When is the study starting and how long is it expected to run for?
May 2018 to December 2022

Who is funding the study?
Governmental funding for clinical research within the Health Care Sector

Who is the main contact?
Prof. Lisa Rydén
lisa.ryden@med.lu.se
Dr Christine Lundgren
christine.lundgren@med.lu.se

Trial website

Contact information

Type

Scientific

Primary contact

Prof Lisa Rydén

ORCID ID

http://orcid.org/0000-0001-7515-3130

Contact details

Box 177
Lund
SE-221 00
Sweden
+46706720923
lisa.ryden@med.lu.se

Type

Scientific

Additional contact

Dr Christine Lundgren

ORCID ID

http://orcid.org/0000-0002-7880-2981

Contact details

Department of Clinical Sciences Lund
Division of Oncology and Pathology
Lund University
Medicon Village
Building 404
Scheelevägen 8
Lund
22363
Sweden
+46 10 24 229 00
christine.lundgren@med.lu.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

SBII:2 BioLong (1)

Study information

Scientific title

Premenopausal patients randomized to adjuvant tamoxifen versus not: long-term survival in relation to genomic and tumor related factors

Acronym

SBII:2 BioLong

Study hypothesis

Comprehensive genomic and histopathological characterization of primary tumours can improve prediction of long-term prognosis and tamoxifen response in premenopausal patients

Ethics approval

1. Approved 02/02/2017 Lund ethics committee (Box 133, 221 00, Lund; +46 2224180; eva.elvstrand@epn.lu.se), ref: 2015/6
2. Approval for long-term follow-up (Dnr number LU 2015/350) and genomic analyses (Dnr LU 2017/97)

Study design

Prospective-retrospective multicentre interventional randomized trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Premenopausal patients with invasive breast cancer

Intervention

The SBII:2 BioLong study is based on a prospective multicenter randomized clinical trial with > 30 years of follow-up of adjuvant tamoxifen

We will collect formalin-fixed archival tissue for gross evaluation of tumour-infiltrating lymphocytes, characterization of them and assessment of lymphovascular invasion in relation to the primary outcome. RNA and DNA will be extracted to enable RNA profiling by PAM50 and additional gene expression analysis with the 360TM panel. Mutational analysis is scheduled to include ESR1, p53, FGFR and PI3K to identify mutations of importance for tamoxifen resistance. The PAM50 and Risk of Recurrence has been thoroughly evaluated on tumors from postmenopausal patients allocated to hormonal therapy and provides additional prognostic information to conventional prognostic markers. Data on prognosis by PAM50 for premenopausal women is sparse and restricted to less than 10 years of follow up. Surrogate subtyping will additionally be compared to the intrinsic subtypes in terms of prognostic capacity

The original SBII:2 trial (1986-1991) is unique as its inclusion was restricted to premenopausal patients and the control arm includes patients without any systemic therapy, the intervention arm received two years of therapy with tamoxifen. The 30 years of follow-up regarding breast cancer mortality, breast cancer-free interval (BCFi) and distant recurrence-free interval (D-RFi) has been published. The SBII:2 BioLong study will add important genomic and histopathological data to improve our knowledge on factors of importance for long-term prognosis in premenopausal patients.

Intervention type

Drug

Phase

Not Applicable

Drug names

Tamoxifen

Primary outcome measure

BCFi (Breast cancer free interval) over the ~30 year period, measured using patient notes

Secondary outcome measures

1. D-RFi (Distant Recurrence Free interval) over the ~30 year period, measured using patient notes
2. Breast cancer mortality over the ~30 year period, measured using patient notes
3. Overall mortality over the ~30 year period, measured using patient notes

Overall trial start date

01/09/2014

Overall trial end date

31/12/2022

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients radically operated for invasive breast cancer stage II in the SBII:2 trial

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

500

Participant exclusion criteria

1. Postmenopausal status
2. Metastatic disease

Recruitment start date

01/05/2018

Recruitment end date

31/12/2022

Locations

Countries of recruitment

Sweden

Trial participating centre

Skåne University Hospital
Box 177
Lund
SE-221 00
Sweden

Sponsor information

Organisation

Lund University

Sponsor details

Box 177
Lund
SE-221 00
Sweden
+46-46-2220000
mikael.bodelsson@med.lu.se

Sponsor type

Government

Website

https://www.medicine.lu.se/

Funders

Funder type

Government

Funder name

Governmental funding for clinical research within the Health Care Sector

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fre Bertha Kamprad Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Anna och Edwin Bergers Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Gyllenstiernska Krapperup Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Futurum— the Academy for Health and Care

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Clinical Cancer Research Foundation in Jönköping

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The SBII:2 BioLong Study will continuously be presented at international congresses and in publications, we anticipate to publish the first report in 2020

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request

Intention to publish date

30/11/2020

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

09/12/2019: Internal review. 06/12/2019: Uploaded protocol (not peer reviewed) 04/11/2019: Trial’s existence confirmed by Lund ethics committee