NCT02900469

Brief Summary

The purpose of this study is to determine whether one dose of denosumab can lead to changes in the tumor, which may decrease the ability of tumor to spread.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P50-P75 for early_phase_1 breast-cancer

Timeline
Completed

Started Oct 2016

Typical duration for early_phase_1 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2016

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 14, 2016

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 3, 2020

Completed
Last Updated

August 21, 2020

Status Verified

August 1, 2020

Enrollment Period

3.2 years

First QC Date

August 29, 2016

Last Update Submit

August 19, 2020

Conditions

Breast Cancer

Keywords

RANKRANKL

Outcome Measures

Primary Outcomes (1)

  • Pharmacodynamic markers of RANKL inhibition determination

    Immunohistochemical analyses (IHC) of RANK and RANKL protein expression will be performed by Clarient Diagnostics Services Inc., Aliso Viejo, CA using prototype assays developed and optimized by Dako on their automated staining platform

    Change from baseline RANKL inhibition determination at one month

Secondary Outcomes (1)

  • Frequency of RANK and RANKL protein expression (by IHC) in operable breast cancer using Immunohistochemical analyses (IHC)

    Change from baseline frequency of RANK and RANKL protein expression at one month

Study Arms (1)

Denosumab & surgery

EXPERIMENTAL

denosumab: 120 mg subcutaneous injection Surgery: 2-4 weeks after denosumab

Biological: denosumabProcedure: Surgery

Interventions

denosumabBIOLOGICAL

denosumab: 120 mg subcutaneous injection

Also known as: Xgeva
Denosumab & surgery
SurgeryPROCEDURE

Surgery: approximately 2-4 weeks after dosing of denosumab

Denosumab & surgery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have histologically confirmed invasive breast cancer (stages I-III) who have undergone core needle biopsy (clinically or radiographically at least T1c to allow adequate residual cancer tissue at surgery) and will be scheduled for surgical resection (i.e. segmental excision or mastectomy).
  • Archival tissue freshly cut from core biopsy must be available; patients who had a diagnostic core biopsy at an outside institution are eligible as long as it is confirmed that tumor specimens in paraffin blocks (preferred) or ≥ 25 unstained slides, with an associated pathology report, are available.
  • Female, Age ≥18 years (pre or postmenopausal).
  • Signed informed consent
  • Serum calcium or albumin-adjusted serum calcium ≥2.0mmol/L (8.0mg/dL) and ≤ 2.9 mmol/L (11.5mg/dL)
  • Patients with reproductive potential must be willing to use, in combination with her partner, 2 acceptable methods of effective contraception or practice sexual abstinence throughout the study and continue for 5 months after study duration. Subjects who are surgically sterile (eg, history of bilateral tubal ligation, hysterectomy) or whose sexual partner is sterile (eg, history of vasectomy) are not required to use additional contraceptive measures.

You may not qualify if:

  • Consideration for neoadjuvant therapy
  • Serious infections including a history of active Hepatitis B, Hepatitis C or HIV
  • Subject has known sensitivity to any of the products to be administered during the study (e.g.., mammalian derived products, calcium, or vitamin D)
  • Subject is pregnant or breast feeding, or planning to become pregnant/breastfeed while on study through 5 months after the end of treatment
  • Patients have prior history or current evidence of osteonecrosis or osteomyelitis of the jaw, evidence of untreated local gum or oral infection, or non-healed dental or oral surgery
  • Patients with active dental or jaw conditions which require oral surgery/dental procedures, including tooth extraction for the course of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Perlmutter Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

DenosumabSurgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Sylvia Adams, MD

    NYU Perlmutter Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 14, 2016

Study Start

October 1, 2016

Primary Completion

December 3, 2019

Study Completion

January 3, 2020

Last Updated

August 21, 2020

Record last verified: 2020-08

Locations

US(1)