# Safety Study of Adding Everolimus to Adjuvant Hormone Therapy in Women With High Risk of Relapse, ER+ and HER2- Primary Breast Cancer, Free of Disease After Receiving at Least One Year of Adjuvant Hormone Therapy

> **NCT01805271** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **UNICANCER** · enrollment: 1278 (actual)

## Conditions studied

- Primary Non-metastatic Breast Cancer
- Who Remain Disease-free

## Interventions

- **DRUG:** Everolimus
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT01805271
- **Lead sponsor:** UNICANCER
- **Sponsor class:** OTHER
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2013-03
- **Primary completion:** 2020-06
- **Final completion:** 2030-06
- **Target enrollment:** 1278 (ACTUAL)
- **Last updated:** 2025-05-14

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01805271

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01805271, "Safety Study of Adding Everolimus to Adjuvant Hormone Therapy in Women With High Risk of Relapse, ER+ and HER2- Primary Breast Cancer, Free of Disease After Receiving at Least One Year of Adjuvant Hormone Therapy". Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/clinical/NCT01805271. Licensed CC0.

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