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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 February 2021 |
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Main ID: |
NCT02536625 |
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Date of registration:
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14/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of the Impact of Everolimus Treatment on Lymphocytes NK (Natural Killer) Development and Functions for Patients With a Metastatic Breast Cancer (HR+ / HER2/Neu Negative)
RAPANK |
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Scientific title:
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RAPANK: Study of the Impact of Everolimus Treatment on the Development and Functions of Lymphocytes NK (Natural Killer), for Patients With a Metastatic Breast Cancer (HR+ / HER2/Neu Negative) |
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Date of first enrolment:
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October 2015 |
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Target sample size:
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62 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02536625 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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France
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Contacts
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Name:
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TREDAN Olivier, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Leon Berard |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Women > 18 years old
- Metastatic breast cancer HR+ (Hormone Receptor positive), HER2/neu negative (Human
Epidermal Growth Factor Receptor-2)
- ECOG PS (Eastern Cooperative Oncology Group Performance Status) =2
- Eligible to an hormonotherapy treatment combined to an mTOR (mammalian Target Of
Rapamycin) inhibitor (i.e. SPC (Summary of Product Characteristics) modalities)
- Measurable disease according to RECIST 1.1 (Response Evaluation Criteria In Solid
Tumors)
- Not receiving the non-authorized concomitant treatments
- Patient should understand, sign, and date the written voluntary informed consent form
at the screening visit prior to any protocol-specific procedures performed.
- Patients must be covered by a medical insurance
Exclusion Criteria:
- BMI>30
- All dysimmune disease, history of transplantation or immunosuppressive therapy or
corticotherapy
- All chronic inflammatory diseases
- Last chemotherapy < 6 months
- Corticotherapy <1 year and more than 1 month
- Restrictive diet =3 months before inclusion
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Other: prospective study
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Primary Outcome(s)
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Measure of the level of Granzyme B (GzmB)
[Time Frame: Timepoint at 3 months]
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Secondary Outcome(s)
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Intercurrent diseases reporting
[Time Frame: 12 months]
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mTOR activation status
[Time Frame: Timepoint at 3 months and at 9 months]
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Objective Response Rate
[Time Frame: 12 months]
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Overall Survival (OS)
[Time Frame: 12 months]
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Progression-Free Survival (PFS)
[Time Frame: 12 months]
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Circulating NK functions
[Time Frame: Timepoint at 3 months and at 9 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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