Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer

Breast Cancer Clinical Trial

— SWE-Switch  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06223698
• Other study ID #: 280050
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 2, 2024
• Est. completion date: May 2, 2035

Study information

• Verified date: December 2023
• Source: Region Örebro County
• Contact: Antonis Valachis, MD, PhD
• Phone: 0046 196021000
• Email: antonios.valachis[@]oru.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 3832
• Est. completion date: May 2, 2035
• Est. primary completion date: May 2, 2032
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

Cohort 1 (premenopausal women at diagnosis converted to postmenopausal)

1. Women who were pre- or perimenopausal at diagnosis

2. Luminal breast cancer (defined as estrogen-receptor positive >/=10%, HER2-negative disease).

3. Treated with tamoxifen for at least 80% of a 5-year period (+/- 6 months from treatment completion).

4. No clinical signs of metastasis after 5 years tamoxifen treatment.

5. cN+ breast cancer at diagnosis indicating the need for extended adjuvant endocrine therapy.

6. Postmenopausal status at study entry defined according to the National Comprehensive Cancer Network Guidelines.

Cohort 2 (postmenopausal women at breast cancer diagnosis)

1. Women who were postmenopausal at diagnosis.

2. Luminal breast cancer (defined as estrogen-receptor positive >/=10%, HER2-negative disease).

3. Treated with AI for at least 80% of a 5-year period (+/- 6 months from treatment completion).

4. No clinical signs of metastasis after 5 years AI treatment.

5. cN+ breast cancer at diagnosis indicating the need for extended adjuvant endocrine therapy.

Exclusion Criteria:

Cohort 1

1. Prior invasive breast cancer diagnosis.

2. Other invasive malignancy within 5 years before or after breast cancer diagnosis

3. Non-luminal breast cancer (defined as estrogen-receptor < 10%).

4. Patients who were unable to complete at least 80% of 5-year initial treatment with tamoxifen.

5. Uncertain menopausal status (unable to evaluate menopausal status according to aforementioned definitions).

6. 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

1. Prior invasive breast cancer diagnosis.

2. Other invasive malignancy within 5 years before or after breast cancer diagnosis; non-Luminal breast cancer (defined as estrogen-receptor < 10%).

3. Patients who were unable to complete at least 80% of 5-year initial treatment with AI.

4. 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Letrozole
Letrozole 2.5 mg daily
• Anastrozole
Anastrozole 1 mg daily
• Exemestane
Exemestane 25 mg daily
• Tamoxifen
Tamoxifen 20 mg daily

Locations

Country	Name	City	State
Sweden	General Hospital of Eskilstuna	Eskilstuna
Sweden	Falun County Hospital	Falun
Sweden	Sahlgrenska University Hospital	Göteborg
Sweden	Ryhov County Hospital	Jönköping
Sweden	Lund University Hospital	Lund
Sweden	Örebro University Hospital	Örebro
Sweden	Karolinska University Hospital	Stockholm
Sweden	University Hospital of Umeå	Umeå
Sweden	Akademiska University Hospital Uppsala	Uppsala
Sweden	Västerås General Hospital	Västerås

Sponsors (3)

Lead Sponsor	Collaborator
Region Örebro County	Akademiska University Hospital, Uppsala, Sweden, Mid-Sweden Regional Cancer Centre

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		120 months
Secondary	Invasive disease-free survival		36 months; 60 months; 120 months
Secondary	Distant disease-free survival		36 months; 60 months; 120 months
Secondary	Breast cancer-specific survival		36 months; 60 months; 120 months
Secondary	Overall survival		36 months; 60 months
Secondary	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.	36 months; 60 months; 120 months
Secondary	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)	24 months; 60 months
Secondary	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	36 months; 60 months; 120 months
Secondary	Duration of sick leave		36 months; 60 months; 120 months