Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT01805271 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusActive, Not Recruiting
PhasePhase 3
SponsorUNICANCER
Started
View on ClinicalTrials.gov ↗

Record History

  1. 4 versions Re-verified since Feb 28, 2023, no change to tracked fieldsv11-v14
  2. Enrollment target: 1279 to 1278 Eligibility criteria shortened, about 1 wordv10 Show 1 more changeShow less
    • Eligibility criteria shortened, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date changed from estimate of Dec 2020 to Jun 2020 Completion date: Apr 2025 to Jun 2030v9 Show 1 more changeShow less
    • Completion date: Apr 2025 to Jun 2030
  4. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 1984 to confirmed 1279 · Primary completion date: Jun 2021 to Dec 2020 · Completion date: Jun 2031 to Apr 2025 · 2 morev8 Show 5 more changesShow less
    • Enrollment target: estimated 1984 to confirmed 1279
    • Primary completion date: Jun 2021 to Dec 2020
    • Completion date: Jun 2031 to Apr 2025
    • Eligibility criteria shortened, about 7 words
    • Site details revised at 2 of 2 sites

    See this version in full on ClinicalTrials.gov ↗

  5. 2 versions Re-verified since Oct 5, 2018, no change to tracked fieldsv6-v7
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: Jan 2018 to Jun 2021 Primary endpoint revised · Completion date: Jan 2018 to Jun 2031 · Eligibility criteria expanded, about 11 wordsv5 Show 3 more changesShow less
    • Primary endpoint revised
    • Completion date: Jan 2018 to Jun 2031
    • Eligibility criteria expanded, about 11 words

    See this version in full on ClinicalTrials.gov ↗

  2. Eligibility criteria expanded, about 70 words Study title expanded, about 4 wordsv4 Show 1 more changeShow less
    • Study title expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  3. Eligibility criteria expanded, about 27 words Collaborator revisedv3 Show 1 more changeShow less
    • Collaborator revised

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 2v2 Show 1 more changeShow less
    • Study sites: 1 to 2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
UNICANCER
98 trials monitored
See 7 trials at risk
Breast Cancer
5,213 trials monitored
See 271 trials at risk
A significant number of patients relapse and eventually die, particularly if they were initially diagnosed with large nodes involvement and/or T3/4 diseases. When analyses focus on patients with ER+/Her2-negative breast cancer, with ≥4N+, 30% had relapsed at 5 years, emphasizing the need for new drugs in this setting (PACS01 data, UNICANCER internal data). Strong evidence suggests that cross-talk between the phosphatidylinositol 3-kinase (PI3K)/AKT/mammalian target of rapamycin (mTOR) pathway and ER signaling is linked to hormone resistance in breast cancer patients. In the present study, we plan to evaluate the benefit from adding everolimus to standard endocrine treatments after three years of treatment for patient ER+/HER2- at high risk of relapse due to high nodes involvement (≥4) and/or persistent node involvement after neo-adjuvant chemotherapy. Genomic signatures have emerged during the last 10 years as a new and additive means to evaluate more precisely long term prognosis, and in some instances the amount of benefit from chemotherapy or endocrine therapy in the adjuvant setting. Therefore, the UNIRAD study can be proposed to patients with 1-3 positive lymph nodes at primary surgery and a high risk of relapse with the EndoPredict test. This study is a unique opportunity to prove the efficacy of everolimus in adjuvant setting. The study could be practice changing in case of positive results and could allow improving outcome of breast cancer patients presenting high risk of metastatic relapse.
Trial Details
NCT Number NCT01805271
Lead Sponsor UNICANCER
Collaborators: Ministry of Health, France
Conditions Primary Non-metastatic Breast Cancer, Who Remain Disease-free
Enrollment 1,278 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov