Biomarker Study of the Antitumoral Activity of Denosumab in the Pre- Operative Setting of Early Breast Cancer

NCT03691311 · Status: UNKNOWN · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2021-11-03

No results posted yet for this study

Summary

This is a biomarker study designed to test the preclinically generated hypothesis of anti-tumoral activity of denosumab in patients with early breast cancer candidates a tumour excision

Conditions

  • Breast Neoplasm Female
  • Stage I Breast Cancer
  • Stage II Breast Cancer
  • Hormone Receptor Negative Neoplasm
  • Hormone Receptor Positive Tumor

Interventions

DRUG

Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]

Two injections on days 1 and 8 previous to surgery breast cancer excision

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY
  • Institut Català d'Oncologia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-05
Primary Completion
2022-07-05
Completion
2023-02-05

Countries

  • Spain

Study Locations

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Entities

Companies

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 NCT03691311 on ClinicalTrials.gov