Search / Trial NCT06223698

Optimizing Extended Adjuvant Endocrine Therapy in Patients With Breast Cancer

Launched by REGION ÖREBRO COUNTY · Jan 16, 2024

Trial Information

Current as of December 22, 2024

Not yet recruiting

Keywords

Breast Cancer Adjuvant Therapy Endocrine Treatment Extended Therapy

ClinConnect Summary

No description provided

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.

About Region örebro County

Region Örebro County is a leading healthcare organization dedicated to advancing medical research and improving patient care through innovative clinical trials. Committed to fostering collaboration between researchers, healthcare professionals, and the community, Region Örebro County facilitates a wide range of studies aimed at evaluating new treatments and interventions across various medical fields. By prioritizing patient safety and ethical standards, the region aims to contribute valuable insights that enhance medical knowledge and improve health outcomes for populations both locally and globally.

Locations

Lund, , Sweden

Göteborg, , Sweden

Stockholm, , Sweden

örebro, , Sweden

Umeå, , Sweden

Jönköping, , Sweden

Eskilstuna, , Sweden

Falun, , Sweden

Uppsala, , Sweden

Västerås, , Sweden

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0