Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer

Phase 3

Not yet recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Letrozole; Drug: Tamoxifen; Drug: Anastrozole; Drug: Exemestane

• Registration Number: NCT06223698
• Lead Sponsor: Region Örebro County

Brief 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 adjuvan...

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2023-12-29
• Study First Submitted QC: 2024-01-16
• Study First Posted: 2024-01-25
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19
• Study Start: 2025-01-02
• Primary Completion: 2032-05-02
• Study Completion: 2035-05-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 3832

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1: Aromatase inhibitors for 5 years	Letrozole	Cohort 1 (premenopausal at diagnosis =\> postmenopausal at randomization) 5-year tamoxifen =\> Randomized to Arm A (switching to aromatase inhibitors for 5 years).
Cohort 2: Aromatase inhibitors for 2 years	Exemestane	Cohort 2 (postmenopausal at diagnosis) 5-year aromatase inhibitors =\> Randomized to Arm B (continuing with AI for 2 years).
Cohort 1: Aromatase inhibitors for 5 years	Anastrozole	Cohort 1 (premenopausal at diagnosis =\> postmenopausal at randomization) 5-year tamoxifen =\> Randomized to Arm A (switching to aromatase inhibitors for 5 years).
Cohort 1: Aromatase inhibitors for 5 years	Exemestane	Cohort 1 (premenopausal at diagnosis =\> postmenopausal at randomization) 5-year tamoxifen =\> Randomized to Arm A (switching to aromatase inhibitors for 5 years).
Cohort 1: Tamoxifen for 5 years	Tamoxifen	Cohort 1 (premenopausal at diagnosis =\> postmenopausal at randomization) 5-year tamoxifen =\> Randomized to Arm B (continuing with tamoxifen for 5 years).
Cohort 2: Tamoxifen for 5 years	Tamoxifen	Cohort 2 (postmenopausal at diagnosis) 5-year aromatase inhibitors =\> Randomized to Arm A (switching to tamoxifen for 5 years).
Cohort 2: Aromatase inhibitors for 2 years	Letrozole	Cohort 2 (postmenopausal at diagnosis) 5-year aromatase inhibitors =\> Randomized to Arm B (continuing with AI for 2 years).
Cohort 2: Aromatase inhibitors for 2 years	Anastrozole	Cohort 2 (postmenopausal at diagnosis) 5-year aromatase inhibitors =\> Randomized to Arm B (continuing with AI for 2 years).

Primary Outcome Measures

Name	Time	Method
Overall survival	120 months

Secondary Outcome Measures

Name	Time	Method
Adherence to treatment strategies (medical possession ratio)	36 months; 60 months; 120 months	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
Duration of sick leave	36 months; 60 months; 120 months
Invasive disease-free survival	36 months; 60 months; 120 months
Distant disease-free survival	36 months; 60 months; 120 months
Breast cancer-specific survival	36 months; 60 months; 120 months
Overall survival	36 months; 60 months
Frequency of selected grade 3/4 toxicities	36 months; 60 months; 120 months	Selected grade 3 or 4 toxicities that lead to hospitalization will be captured and analyzed for each study arm.
Overall quality of life (EORTC QLQC30)	24 months; 60 months	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)

Trial Locations

Locations (10)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

University Hospital of Umeå; 🇸🇪 Umeå, Sweden

Akademiska University Hospital Uppsala; 🇸🇪 Uppsala, Sweden

Örebro University Hospital; 🇸🇪 Örebro, Sweden

Västerås General Hospital; 🇸🇪 Västerås, Sweden

Falun County Hospital; 🇸🇪 Falun, Sweden

Ryhov County Hospital; 🇸🇪 Jönköping, Sweden

Sahlgrenska University Hospital; 🇸🇪 Göteborg, Sweden

General Hospital of Eskilstuna; 🇸🇪 Eskilstuna, Sweden

Lund University Hospital; 🇸🇪 Lund, Sweden