Presurgical Trial of Denosumab in Breast Cancer

Completed · Early Phase 1

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02900469

Run by

NYU Langone Health

People needed

44

Starts

2016-10-01

Expected to finish

2020-01-03

Last updated by the study team

2020-08-21

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• NYU Perlmutter Cancer Center — New York, New York, United States

Full record on ClinicalTrials.gov

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