Optimizing endocrine treatment > 5 years after surgery for breast cancer patients: a registry-based randomized clinical trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Region Oerebro Laen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

10 Sep 2025 → ongoing

Decision date (initial)

2023-10-12

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

1) In women with high-risk luminal breast cancer who converted from premenopausal to postmenopausal after an initial adjuvant endocrine therapy of 5 years tamoxifen, to investigate if extended therapy using a switching strategy with 5-years of aromatase inhibitors (AI) is more effective than continued tamoxifen therapy for 5 years.
2) In postmenopausal women with high-risk luminal breast cancer after an initial adjuvant endocrine therapy of 5-year AI, to investigate whether an extended adjuvant therapy using a switching strategy of 5-year tamoxifen is more effective than 2-year of AI.

Conditions and MedDRA coding

Breast cancer

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Inclusion criteria for Cohort 1 (premenopausal women at diagnosis converted to postmenopausal): 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; cN+ breast cancer at diagnosis indicating the need for extended adjuvant endocrine therapy; postmenopausal status at study entry defined according to the National Comprehensive Cancer Network Guidelines; inclusion criteria for cohort 2: (postmenopausal women at diagnosis): Women who were postmenopausal at diagnosis; luminal breast cancer (defined as estrogen-receptor positive >/=10%, HER2-negative disease); treated with AI for at least 80% of a 5-year period (+/- 6 months from treatment completion); no clinical signs of metastasis after 5 years AI treatment; cN+ breast cancer at diagnosis indicating the need for extended adjuvant endocrine therapy.

Exclusion criteria 1

1. Exclusion criteria for Cohort 1: 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; uncertain menopausal status (unable to evaluate menopausal status according to aforementioned definitions); 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. Exclusion criteria for cohort 2: Exclusion criteria for Cohort B: 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 AI; 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; no contraindication for tamoxifen therapy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Overall survival

Secondary endpoints 1

1. Invasive disease-free survival; distant disease-free survival; breast cancer-specific survival; toxicity (grade 3 or 4); quality of Life; adherence; healthcare resource utilization; sick leave and early retirement

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Oerebro Laen

Sponsor organisation

Region Oerebro Laen

Address

Sodra Grev Rosengatan

City

Orebro

Postcode

701 85

Country

Sweden

Scientific contact point

Organisation

Region Oerebro Laen

Contact name

Antonis Valachis

Public contact point

Organisation

Region Oerebro Laen

Contact name

Antonis Valachis

Locations

1 EU/EEA country · 15 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 2 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications