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| Name | Class |
|---|---|
| Mid-Sweden Regional Cancer Centre | UNKNOWN |
| Uppsala University Hospital | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: Aromatase inhibitors for 5 years | Experimental | 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 | Active Comparator | 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 | Experimental | 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 | Active Comparator | Cohort 2 (postmenopausal at diagnosis) 5-year aromatase inhibitors => Randomized to Arm B (continuing with AI for 2 years). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole | Drug | Letrozole 2.5 mg daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 120 months |
| Measure | Description | Time Frame |
|---|---|---|
| Invasive disease-free survival | 36 months; 60 months; 120 months | |
| Distant disease-free survival | 36 months; 60 months; 120 months | |
| Breast cancer-specific survival |
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Inclusion Criteria:
Cohort 1 (premenopausal women at diagnosis converted to postmenopausal)
Cohort 2 (postmenopausal women at breast cancer diagnosis)
Exclusion Criteria:
Cohort 1
8) Unable to give informed consent in Swedish. Cohort 2
6) No contraindication for tamoxifen therapy. 7) Unable to give informed consent in Swedish.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonis Valachis, MD, PhD | Contact | 0046 196021000 | antonios.valachis@oru.se |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Visby Hospital | Visby | Gotland County | Sweden | |||
| General Hospital of Eskilstuna |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| D000077384 | Anastrozole |
| C056516 | exemestane |
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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Two separate cohorts will be randomized (two arms in each study cohort)
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| Anastrozole | Drug | Anastrozole 1 mg daily |
|
| Exemestane | Drug | Exemestane 25 mg daily |
|
| Tamoxifen | Drug | Tamoxifen 20 mg daily |
|
| 36 months; 60 months; 120 months |
| Overall survival | 36 months; 60 months |
| 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 |
| 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 |
| 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 |
| Duration of sick leave | 36 months; 60 months; 120 months |
| Eskilstuna |
| Sweden |
|
| Falun County Hospital | Falun | Sweden |
|
| Gävle Hospital | Gävle | Sweden |
|
| Sahlgrenska University Hospital | Gothenburg | Sweden |
|
| Ryhov County Hospital | Jönköping | Sweden |
|
| Kalmar Hospital | Kalmar | Sweden |
|
| Lund University Hospital | Lund | Sweden |
|
| Örebro University Hospital | Örebro | Sweden |
|
| Karolinska University Hospital | Stockholm | Sweden |
|
| St Göran Capio Hospital | Stockholm | Sweden |
|
| University Hospital of Umeå | Umeå | Sweden |
|
| Akademiska University Hospital Uppsala | Uppsala | Sweden |
|
| Växjö Hospital | Vaxjo | Sweden |
|
| Västerås General Hospital | Västerås | Sweden |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |