Trials / Unknown
UnknownNCT03691311
Biomarker Study of the Antitumoral Activity of Denosumab in the Pre- Operative Setting of Early Breast Cancer
An Open Label Biomarker Pilot Study of the Antitumoral Activity of Denosumab in the Pre- Operative Setting of Early Breast Cancer
- Status
- Unknown
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- Sponsor
- Institut Català d'Oncologia · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Detailed description
This is a biomarker study designed to test in patients the preclinically generated hypothesis of anti-tumoral activity of denosumab.The main objective is to demonstrate the antiproliferative and/or pro-apoptotic activity of denosumab in early breast cancer. Other endpoints are to correlate denosumab activity with RANK and RANKL expressions through mRNA and protein; to characterize the differential antiproliferative activity of denosumab between different phenotypes of breast cancer; to identify biomarkers, to identify global changes in gene expression and validate the activity of RANKL antibody in clinical samples. A total of 60 patients with early breast cancer (Stages I and II) candidates to tumor excision as first therapeutic approach will be randomized 2:1, a treatment arm that will receive two doses of denosumab following diagnosis, and a control arm that will not receive treatment. At least 24 patients with hormone receptor negative breast cancer and 24 premenopausal patients will be included in the study.
Conditions
- Breast Neoplasm Female
- Stage I Breast Cancer
- Stage II Breast Cancer
- Hormone Receptor Negative Neoplasm
- Hormone Receptor Positive Tumor
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA] | Two injections on days 1 and 8 previous to surgery breast cancer excision |
Timeline
- Start date
- 2018-07-05
- Primary completion
- 2022-07-05
- Completion
- 2023-02-05
- First posted
- 2018-10-01
- Last updated
- 2021-11-03
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT03691311. Inclusion in this directory is not an endorsement.