Breast Cancer Clinical Trial
Official title:
Pre-surgical Evaluation of Denosumab in Patients With Operable Invasive Breast Cancer
Verified date | August 2020 |
Source | NYU Langone Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 44 |
Est. completion date | January 3, 2020 |
Est. primary completion date | December 3, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | NYU Perlmutter Cancer Center | New York | New York |
Lead Sponsor | Collaborator |
---|---|
NYU Langone Health |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Frequency of RANK and RANKL protein expression (by IHC) in operable breast cancer using Immunohistochemical analyses (IHC) | 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 frequency of RANK and RANKL protein expression at one month |
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