Optimizing Extended Adjuvant Endocrine Therapy in Patients with Breast Cancer

Last updated: January 3, 2025
Sponsor: Region Örebro County
Overall Status: Active - Not Recruiting

Phase

3

Condition

Breast Cancer

Cancer

Treatment

Anastrozole

Letrozole

Exemestane

Clinical Study ID

NCT06223698
280050
  • Ages 18-90
  • Female

Study 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 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

Inclusion

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-negativedisease).

  3. Treated with tamoxifen for at least 80% of a 5-year period (+/- 6 months fromtreatment completion).

  4. No clinical signs of metastasis after 5 years tamoxifen treatment.

  5. cN+ breast cancer at diagnosis indicating the need for extended adjuvant endocrinetherapy.

  6. Postmenopausal status at study entry defined according to the National ComprehensiveCancer 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-negativedisease).

  3. Treated with AI for at least 80% of a 5-year period (+/- 6 months from treatmentcompletion).

  4. No clinical signs of metastasis after 5 years AI treatment.

  5. cN+ breast cancer at diagnosis indicating the need for extended adjuvant endocrinetherapy.

Exclusion

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 withtamoxifen.

  5. Uncertain menopausal status (unable to evaluate menopausal status according toaforementioned definitions).

  6. Recurrent or metastatic breast cancer within or after 5-year initial treatment withtamoxifen (DCIS-only is allowed at any time before or after breast cancerdiagnosis).

  1. 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 withAI.

  4. Recurrent or metastatic breast cancer within or after 5-year initial treatment withAI (DCIS-only is allowed at any time before or after breast cancer diagnosis).

  1. No contraindication for tamoxifen therapy. 7) Unable to give informed consent inSwedish.

Study Design

Total Participants: 3832
Treatment Group(s): 4
Primary Treatment: Anastrozole
Phase: 3
Study Start date:
January 02, 2025
Estimated Completion Date:
May 02, 2035

Connect with a study center

  • Visby Hospital

    Visby, Gotland
    Sweden

    Site Not Available

  • General Hospital of Eskilstuna

    Eskilstuna,
    Sweden

    Site Not Available

  • Falun County Hospital

    Falun,
    Sweden

    Site Not Available

  • Gävle Hospital

    Gävle,
    Sweden

    Site Not Available

  • Sahlgrenska University Hospital

    Göteborg,
    Sweden

    Site Not Available

  • Ryhov County Hospital

    Jönköping,
    Sweden

    Site Not Available

  • Kalmar Hospital

    Kalmar,
    Sweden

    Site Not Available

  • Lund University Hospital

    Lund,
    Sweden

    Site Not Available

  • Karolinska University Hospital

    Stockholm,
    Sweden

    Site Not Available

  • St Göran Capio Hospital

    Stockholm,
    Sweden

    Site Not Available

  • University Hospital of Umeå

    Umeå,
    Sweden

    Site Not Available

  • Akademiska University Hospital Uppsala

    Uppsala,
    Sweden

    Site Not Available

  • Västerås General Hospital

    Västerås,
    Sweden

    Site Not Available

  • Växjö Hospital

    Växjö,
    Sweden

    Site Not Available

  • Örebro University Hospital

    Örebro,
    Sweden

    Site Not Available

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