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Breast CancerPhase 3SWE-SwitchNCT06223698

Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer

A Phase 3 study testing Letrozole, Anastrozole and Exemestane in people with Breast Cancer, run by Region Örebro County at 15 sites in Sweden.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Based on the risk of late recurrence in breast cancer patients with luminal disease with high-risk for recurrence, extended adjuvant endocrine therapy beyond 5 years is recommended as a valid treatment option. Read more about this study

Who is it for?
Ages 18 to 90 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Letrozole, Anastrozole and Exemestane
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,832 participants
Where
15 sitesSweden
Study dates
2 May 2025to 2 May 2035
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Cohort 1 (premenopausal women at diagnosis converted to postmenopausal)
  • Women who were pre- or perimenopausal at diagnosis
  • Luminal breast cancer (defined as estrogen-receptor positive >/=10%, HER2-negative disease).
  • Treated with tamoxifen for at least 80% of a 5-year period (+/- 6 months from treatment completion).
  • No clinical signs of metastasis after 5 years tamoxifen treatment.
  • cN+ breast cancer at diagnosis indicating the need for extended adjuvant endocrine therapy.
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  • Postmenopausal status at study entry defined according to the National Comprehensive Cancer Network Guidelines.
  • Cohort 2 (postmenopausal women at breast cancer diagnosis)
  • Women who were postmenopausal at diagnosis.
  • Luminal breast cancer (defined as estrogen-receptor positive >/=10%, HER2-negative disease).
  • Treated with AI for at least 80% of a 5-year period (+/- 6 months from treatment completion).
  • No clinical signs of metastasis after 5 years AI treatment.
  • cN+ breast cancer at diagnosis indicating the need for extended adjuvant endocrine therapy.

Who cannot join

  • Cohort 1
  • Prior invasive breast cancer diagnosis.
  • Other invasive malignancy within 5 years before or after breast cancer diagnosis
  • Non-luminal breast cancer (defined as estrogen-receptor < 10%).
  • Patients who were unable to complete at least 80% of 5-year initial treatment with tamoxifen.
  • Uncertain menopausal status (unable to evaluate menopausal status according to aforementioned definitions).
Show all 13Show fewer
  • Recurrent or metastatic breast cancer within or after 5-year initial treatment with tamoxifen (DCIS-only is allowed at any time before or after breast cancer diagnosis).
  • 8) Unable to give informed consent in Swedish. Cohort 2
  • Prior invasive breast cancer diagnosis.
  • Other invasive malignancy within 5 years before or after breast cancer diagnosis; non-Luminal breast cancer (defined as estrogen-receptor < 10%).
  • Patients who were unable to complete at least 80% of 5-year initial treatment with AI.
  • Recurrent or metastatic breast cancer within or after 5-year initial treatment with AI (DCIS-only is allowed at any time before or after breast cancer diagnosis).
  • 6) No contraindication for tamoxifen therapy. 7) Unable to give informed consent in Swedish.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Antonis Valachis, MD, PhD contact

0046 196021000

antonios.valachis@oru.se

15 sites in 1 country

Sweden15 sites

  • General Hospital of Eskilstuna

    Eskilstuna

    Andreas Nearchou, MD

    Andreas Nearchou, MD

  • Falun County Hospital

    Falun

    Maria Annerbo, MD

    Maria Annerbo, MD

  • Gävle Hospital

    Gävle

    Per Edlund, MD, PhD

    Per Edlund

  • Sahlgrenska University Hospital

    Gothenburg

    Barbro Linderholm, MD, PhD

    Barbro Linderholm, MD; PhD

  • Ryhov County Hospital

    Jönköping

    Maria Ekholm, MD, PhD

    Maria Ekholm, MD, PhD

  • Kalmar Hospital

    Kalmar

    Monika Uminska, MD

    Monika Uminska, MD

  • Lund University Hospital

    Lund

    Niklas Loman, MD, PhD

    Niklas Loman, MD, PhD

  • Örebro University Hospital

    Örebro

    Antonis Valachis, MD, PhD

  • Karolinska University Hospital

    Stockholm

    Theodoros Foukakis, MD, PhD

    Theodoros Foukakis, MD, PhD

  • St Göran Capio Hospital

    Stockholm

    Jenny Bergqvist, Md, PhD

    Jenny Bergqvist, MD, PhD

  • University Hospital of Umeå

    Umeå

    Anne Andersson, MD, PhD

    Anne Andersson, MD, PhD

  • Akademiska University Hospital Uppsala

    Uppsala

    Henrik Lindman, MD, PhD

    Henrik Lindman, PD, PhD

  • Västerås General Hospital

    Västerås

    Cecilia Nilsson, MD, PhD

    Cecilia Nilsson, Md, PhD

  • Växjö Hospital

    Vaxjo

    Carina Bayer

    Carina Bayer, MD

  • Visby Hospital

    Visby, Gotland County

Other trials in Sweden

About this study

Official title: Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer: a Registry-based Randomized Clinical Trial - SWE-Switch Breast Cancer Trial

Based on the risk of late recurrence in breast cancer patients with luminal disease with high-risk for recurrence, extended adjuvant endocrine therapy beyond 5 years is recommended as a valid treatment option. In premenopausal women at diagnosis converted to postmenopausal after the first five years of tamoxifen, two treatment strategies for extended adjuvant endocrine therapy are available, namely continuing with tamoxifen or switching to aromatase inhibitors (AI). No randomized evidence does exist and both treatment strategies are used in clinical practice. In postmenopausal women with higher recurrence risk initially treated with AI for five years, extended adjuvant therapy with additional two years of AI has shown to be as effective as additional five years of AI. However, no randomized evidence on whether a switching strategy of five-year extended tamoxifen is better compared to two-year extended AI is available. Both treatment strategies are used in clinical practice.

The primary objective of this register-based randomized trial is to investigate the overall survival between patients treated with switching strategy for extended adjuvant endocrine therapy compared to continuing with the same treatment as the initial 5 years in two different clinical scenarios:

  • In premenopausal women at diagnosis who converted to postmenopausal after 5 years of tamoxifen.
  • In postmenopausal women at diagnosis.
Conditions
Breast Cancer
Being tested
Letrozole, Anastrozole, Exemestane, Tamoxifen
Keywords
breast cancer, adjuvant therapy, endocrine treatment, extended therapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06223698
Study groupRoleWhat they receive
Cohort 1: Aromatase inhibitors for 5 yearsExperimentalCohort 1 (premenopausal at diagnosis => postmenopausal at randomization) 5-year tamoxifen => Randomized to Arm A (switching to aromatase inhibitors for 5 years).
Receives: Drug: Letrozole; Drug: Anastrozole; Drug: Exemestane
Cohort 1: Tamoxifen for 5 yearsActive comparatorCohort 1 (premenopausal at diagnosis => postmenopausal at randomization) 5-year tamoxifen => Randomized to Arm B (continuing with tamoxifen for 5 years).
Receives: Drug: Tamoxifen
Cohort 2: Tamoxifen for 5 yearsExperimentalCohort 2 (postmenopausal at diagnosis) 5-year aromatase inhibitors => Randomized to Arm A (switching to tamoxifen for 5 years).
Receives: Drug: Tamoxifen
Cohort 2: Aromatase inhibitors for 2 yearsActive comparatorCohort 2 (postmenopausal at diagnosis) 5-year aromatase inhibitors => Randomized to Arm B (continuing with AI for 2 years).
Receives: Drug: Letrozole; Drug: Anastrozole; Drug: Exemestane

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

    Measured: 120 months

Secondary outcomes (8)

  1. Invasive disease-free survival

    Measured: 36 months; 60 months; 120 months

  2. Distant disease-free survival

    Measured: 36 months; 60 months; 120 months

  3. Breast cancer-specific survival

    Measured: 36 months; 60 months; 120 months

  4. Overall survival

    Measured: 36 months; 60 months

  5. Frequency of selected grade 3/4 toxicities

    Selected grade 3 or 4 toxicities that lead to hospitalization will be captured and analyzed for each study arm.

    Measured: 36 months; 60 months; 120 months

  6. Overall quality of life (EORTC QLQC30)

    Assessment of overall quality of life through global health status from EORTC QLQC30 (scale 0 to 100; higher score indicates better overall quality of life)

    Measured: 24 months; 60 months

  7. Adherence to treatment strategies (medical possession ratio)

    Adherence will be calculated by using medication possession ratio (MPR; the sum of the days' supply for all fills of a given drug in a particular time period, divided by the number of days in the time period). A MPR of >/= 80% is defined as good adherence

    Measured: 36 months; 60 months; 120 months

  8. Duration of sick leave

    Measured: 36 months; 60 months; 120 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jan 2024
  2. Study start2 May 2025 (estimated)
  3. Primary completion2 May 2032 (estimated)
  4. Study completion2 May 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two separate cohorts will be randomized (two arms in each study cohort)
Masking
None (open label)
Enrolment
3,832 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06223698
Sponsor's protocol ID
280050
Acronym
SWE-Switch
Status last verified
Jan 2025
First submitted
29 Dec 2023
Last updated
20 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Letrozole, Anastrozole and Exemestane in people with Breast Cancer, run by Region Örebro County at 15 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Antonis Valachis, MD, PhD (0046 196021000, antonios.valachis@oru.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival (time frame: 120 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06223698.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.

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