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Durvalumab and Endocrine Therapy in ER+/Her2- Breast Cancer After CD8+ Infiltration Effective Immune-Attractant Exposure

NCT02997995 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2020-09-30

No results posted yet for this study

Summary

This is an open-label, multicentric, international, phase II trial testing aromatase inhibitors in combination with durvalumab in patients with CD8+ T cell infiltration (\>10% CD8+ T cells in the tumor). The trial includes two sequences: The first part of the treatment will consist in 4-6 weeks treatment with immune-attractants; in the second part, CD8+ patients will receive 6 months of durvalumab combined with exemestane.

Conditions

Interventions

DRUG

Immune-attractant

The first cohort patients will receive tremelimumab (3 mg/kg, single infusion) as immune-attractants combined with exemestane (25 mg daily).

DRUG

Durvalumab

Durvalumab (lymphocyte activation) will be administrated at a dose of 1500 mg Q4W (equivalent to 20 mg/kg Q4W) IV, combined with exemestane (25 mg daily), for six months

PROCEDURE

Biopsy

After three weeks (+/- 3 days) of immune-attractants, a tumor biopsy will be done. Patients who present \>10% CD8+ cells in the tumor after 3 weeks will receive the Durvalumab

Sponsors & Collaborators

  • Breast International Group

    collaborator OTHER

  • UNICANCER

    lead OTHER

Principal Investigators

  • Fabrice Andre, Prof · Gustave Roussy, Cancer Campus, Grand Paris

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-15
Primary Completion
2019-07-15
Completion
2020-08-28

Countries

  • France
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02997995 on ClinicalTrials.gov