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)

Breast Cancer Clinical Trial

— RAPANK  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02536625
• Other study ID #: RAPANK
• Status: Completed
• Start date: October 2015
• Est. completion date: December 2019

Study information

• Verified date: February 2021
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

NK (Natural Killer) cells are important in the fight against tumor, especially for the control of cancer metastasis. The purpose of this prospective study is to evaluate the impact on lymphocytes NK functions and development of an everolimus treatment in women treated for a metastatic breast cancer. In particular, the study of lymphocytes NK functions and development under everolimus treatment could permit to validate an early biomarker of the impact of everolimus on these NK cells.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: December 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• prospective study

Locations

Country	Name	City	State
France	Centre Leon Berard	Lyon
France	Centre Hospitalier Lyon Sud	Pierre-Bénite

Sponsors (4)

Lead Sponsor	Collaborator
Centre Leon Berard	Institut National de la Santé Et de la Recherche Médicale, France, Ligue contre le cancer, France, The Biostatistics and Therapy Evaluation Unit

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure of the level of Granzyme B (GzmB)		Timepoint at 3 months
Secondary	Objective Response Rate	The objective response rate (ORR) will be defined as the proportion of patients (described on the efficacy-evaluable population) who achieve complete response (CR) or partial response (PR). ORR is based on tumor assessments (measurements according to RECIST 1.1	12 months
Secondary	Progression-Free Survival (PFS)	Measured from the date of study drugs start to the date of the first objective radiological disease progression using RECIST 1.1 or death.	12 months
Secondary	Overall Survival (OS)	Defined as the duration of time from start of treatment to time of death.	12 months
Secondary	Intercurrent diseases reporting	Number of patients with adverse events (including infectious events) related to everolimus	12 months
Secondary	Circulating NK functions	Characterization of circulating NK functions by flow cytometry	Timepoint at 3 months and at 9 months
Secondary	mTOR activation status	rpS6 phosphorylation rate by western blot	Timepoint at 3 months and at 9 months