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Trial record 4 of 22 for:    denosumab AND breast cancer

Safety Study of Denosumab to Treat Breast Cancer

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified September 2016 by New York University School of Medicine
Sponsor:
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT02900469
First received: August 29, 2016
Last updated: September 8, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Breast Cancer
Biological: denosumab
Procedure: Surgery
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pre-surgical Evaluation of Denosumab in Patients With Operable Invasive Breast Cancer

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Pharmacodynamic markers of RANKL inhibition determination [ Time Frame: Change from baseline RANKL inhibition determination at one month ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Determine the frequency of RANK and RANKL protein expression (by IHC) in operable breast cancer [ Time Frame: Change from baseline frequency of RANK and RANKL protein expression at one month ] [ Designated as safety issue: No ]
    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

  • Determine the frequency of RANK and RANKL gene expression by breast cancer subtype (both, based on estrogen receptor (ER)/progesterone receptor (PR)/human epidermal growth factor receptor 2 (HER2) status as well as PAM50 subtype) [ Time Frame: Change from baseline frequency of RANK and RANKL gene expression at one mont ] [ Designated as safety issue: No ]
    For each subject, tumor tissue from before and after denosumab treatment (paired samples) will be processed via standard of care (SOC) as formalin-fixed and paraffin-embedded tissue and processed as paired samples for gene expression analysis. Tumor receptor status for estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) will be obtained as per SOC (IHC, Fluorescent Insitu Hybridization (FISH))


Estimated Enrollment: 35
Study Start Date: September 2016
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Denosumab & surgery

denosumab: 120 mg subcutaneous injection

Surgery: 2-4 weeks after denosumab

Biological: denosumab
denosumab: 120 mg subcutaneous injection
Other Name: Xgeva
Procedure: Surgery
Surgery: approximately 2-4 weeks after dosing of denosumab

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02900469

Contacts
Contact: Sylvia Adams, MD (212) 263-5795 sylvia.adams@nyumc.org

Locations
United States, New York
NYU Perlmutter Cancer Center Not yet recruiting
New York, New York, United States, 10016
Contact: Sylvia Adams, MD       sylvia.adams@nyumc.org   
Principal Investigator: Sylvia Adams, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Sylvia Adams, MD NYU Perlmutter Cancer Center
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT02900469     History of Changes
Other Study ID Numbers: s14-01311 
Study First Received: August 29, 2016
Last Updated: September 8, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Denosumab
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 26, 2016