Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer

Launched by REGION ÖREBRO COUNTY · Jan 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the best way to continue treatment for women with breast cancer after their initial therapy. Specifically, it looks at two options for women who have completed 5 years of treatment: one group will continue with the same treatment they were on, while the other group will switch to a different medication. This is important because certain types of breast cancer, called luminal breast cancer, can come back even after treatment, so finding the most effective way to prevent recurrence is crucial.

To participate in this trial, women must meet specific criteria. For example, premenopausal women who have completed 5 years of tamoxifen must be postmenopausal at the time of the study, and they should have had no signs of cancer spread after their initial treatment. Postmenopausal women must have been treated with aromatase inhibitors for 5 years and also show no signs of cancer spread. Participants will be monitored to see how well each treatment option works in terms of survival. This trial aims to provide clearer guidance on the best treatment strategies for women at higher risk of breast cancer recurrence.

Gender

FEMALE

Eligibility criteria

• 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.