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.
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT02900469
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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.
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
All locations for NCT02900469
United States (1)
NYU Perlmutter Cancer Center
New York, New York, United States, 10016
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View full eligibility
Tris trial is registered with FDA with number: NCT02900469. The sponsor of the trial is NYU Langone Health and it is looking for 35 volunteers for the current phase.
Official trial title: Pre-surgical Evaluation of Denosumab in Patients With Operable Invasive Breast Cancer
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