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Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-90
SponsorRegion Örebro County

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Letrozole

    Drug

    Letrozole 2.5 mg daily

  • Anastrozole

    Drug

    Anastrozole 1 mg daily

  • Exemestane

    Drug

    Exemestane 25 mg daily

  • Tamoxifen

    Drug

    Tamoxifen 20 mg daily

Treatment groups

3,832 Participants
are divided into 4 treatment groups
Group A: Cohort 1: Aromatase inhibitors for 5 yearsExperimental treatment 3 interventions
Group B: Cohort 1: Tamoxifen for 5 yearsActive comparator 1 intervention
Group C: Cohort 2: Tamoxifen for 5 yearsExperimental treatment 1 intervention
Group D: Cohort 2: Aromatase inhibitors for 2 yearsActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

Overall survival

Time frame
120 months

Secondary outcomes

1

Invasive disease-free survival

Time frame
36 months; 60 months; 120 months
2

Distant disease-free survival

Time frame
36 months; 60 months; 120 months
3

Breast cancer-specific survival

Time frame
36 months; 60 months; 120 months
4

Overall survival

Time frame
36 months; 60 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Region Örebro County

Lead sponsor

Mid-Sweden Regional Cancer Centre

Collaborator

Uppsala University Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: