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
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01805271|
Recruitment Status : Recruiting
First Posted : March 6, 2013
Last Update Posted : June 3, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Primary Non-metastatic Breast Cancer Who Remain Disease-free||Drug: Everolimus Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1984 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Randomized, Double Blind, Multicentric Phase III Trial Evaluating the Safety and Benefit of Adding Everolimus to Adjuvant Hormone Therapy in Women With High Risk of Relapse, ER+ and HER2- Primary Breast Cancer Who Remain Free of Disease After Receiving at Least 1 Year of Adjuvant Hormone Therapy|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2031|
1 or 2 tablets/day (i.e.5 or 10mg/day )
(5 or 10mg/day, i.e. 1 or 2 tablets/day)
Other Name: Afinitor
Placebo Comparator: Placebo
1 or 2 tablets/day
- To evaluate the benefit from adding everolimus to standard endocrine treatments after two years of treatment on the disease-free survival (DFS) [ Time Frame: 2 years ]
- Assessment of impact of everolimus on the overall survival (OS), the Event Free Survival (EFS) and Distant Metastasis Free Survival (DMFS) [ Time Frame: 2 years ]
- Assessment of impact of everolimus on DFS and OS in ER+,PR+ and ER+/PR- subgroups [ Time Frame: 2 years ]
- Impact of everolimus on the incidence of secondary cancers [ Time Frame: 2 years ]
- Assessment of the safety profiles for everolimus and hormone therapy combination. [ Time Frame: 2 years ]
- Biology: Predictive value of mTOR activation markers on DFS: IHC analysis of primary tumor for pS6K and p4EBP. [ Time Frame: 2 years ]
- quality of life sub-studies [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805271
|Contact: Cécile VISSAC-SABATIER, PhD||+33 1 73 79 77 firstname.lastname@example.org|
|Centre Leon Berard||Recruiting|
|Principal Investigator: Thomas Bachelot|
|Principal Investigator: Fabrice Andre|
|Principal Investigator:||Thomas Bachelot, MD, PhD||Centre Leon Berard, Lyon, France|
|Principal Investigator:||Fabrice Andre, MD, PhD||Gustave Roussy, Villejuif, France|