Denosumab in Treating Patients with Invasive Breast Cancer That Can Be Removed by Surgery

Status: Active

Description

This early phase I trial studies how well denosumab works in treating patients with invasive breast cancer that can be removed by surgery. Immunotherapy with monoclonal antibodies, such as denosumab, may induce changes in body’s immune system and may interfere with the ability of tumor cells to grow and spread.

Eligibility 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 from diagnostic/core biopsy must be available; patients who had a biopsy at an outside institution are eligible as long as it is confirmed that an archival tumor specimen, with an associated pathology report, is available
  • Signed informed consent
  • Serum calcium or albumin-adjusted serum calcium >= 2.0 mmol/L (8.0 mg/dL) and =< 2.9 mmol/L (11.5 mg/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 (e.g., history of bilateral tubal ligation, hysterectomy) or whose sexual partner is sterile (e.g., 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 human immunodeficiency virus (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

Locations & Contacts

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Contact: Sylvia Adams
Phone: 212-263-5795
Email: sylvia.adams@nyumc.org

Trial Objectives and Outline

PRIMARY OBJECTIVES:

I. To determine the pharmacodynamic markers of RANKL inhibition in the primary breast tumor in patients with operable invasive breast cancer.

SECONDARY OBJECTIVES:

I. To determine the frequency of RANK and RANKL protein expression (by immunohistochemistry [IHC]) in operable breast cancer.

II. To 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).

EXPLORATORY OBJECTIVES:

I. To assess the tumor microenvironment changes induced by denosumab.

OUTLINE:

Patients receive denosumab subcutaneously (SC) once. Within approximately 2-4 weeks, patients undergo segmental excision or mastectomy.

After completion of study treatment, patients are followed up at 30 days and then periodically for up to 5 years.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type

Treatment

Lead Organization

Lead Organization
Laura and Isaac Perlmutter Cancer Center at NYU Langone

Principal Investigator
Sylvia Adams

Trial IDs

Primary ID S14-01311
Secondary IDs NCI-2016-01614, s14-01311
Clinicaltrials.gov ID NCT02900469