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A Pilot Study of the Impact of a Single Dose of Zoledronic Acid on Biomarkers in Breast Cancer


N/A
N/A
N/A
Open (Enrolling)
Female
Estrogen Receptor-negative Breast Cancer, Estrogen Receptor-positive Breast Cancer, Invasive Ductal Breast Carcinoma, Progesterone Receptor-negative Breast Cancer, Progesterone Receptor-positive Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer

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Trial Information

A Pilot Study of the Impact of a Single Dose of Zoledronic Acid on Biomarkers in Breast Cancer


PRIMARY OBJECTIVES:

I. To evaluate 14 tumor biomarkers of growth and metastasis (10 by microarray and 4 by
RT-PCR) for change in response to ZA.

SECONDARY OBJECTIVES:

I. To evaluate 30 measures of immunologic function (by Luminex panel) for change in response
to ZA a) after 48-72 hours and b) after 21-24 days.

II. To explore additional tumors biomarkers (approximately 20 by immunohistochemistry) for
change in response to ZA.

OUTLINE: Patients receive zoledronic acid intravenously (IV) over 15 minutes on day 1.
Patients then undergo planned definitive surgery (lumpectomy or mastectomy) on day 21-24.
Tissue samples from the initial biopsy and definitive surgery are collected to measure
changes in biomarkers of tumor growth and metastasis, immunologic function, and the
expression of genes important to breast cancer progression and metastasis..


Inclusion Criteria:



- Postmenopausal women

- Early stage, invasive ductal carcinoma for which a lumpectomy or mastectomy is
planned prior to systemic therapy

- Need for diagnostic biopsy (to determine the hormone receptor or human epidermal
growth factor receptor 2 [Her2] status); or willing to undergo a second biopsy if
their diagnostic biopsy was done outside of City of Hope

- Ability to provide informed consent

Exclusion Criteria:

- Tumor that lacks both estrogen and progesterone receptors

- Patients who will receive neoadjuvant therapy prior to definitive surgery

- Bisphosphonate therapy currently or within the past 12 months

- Regular use of anti-inflammatory agents

- Renal impairment as determined by a creatinine clearance < 60 ml/min as calculated by
the Cockroft-Gault formula using the patient's actual weight

- Current active dental problems including infection of the teeth or jawbone (maxilla
or mandibular); dental or fixture trauma, or a current or prior diagnosis of
osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing
after dental procedures

- Recent (within 6 weeks) or planned dental or jaw surgery (e.g. extraction, implants)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Changes in biomarkers of tumor growth and metastasis in women with newly diagnosed ER and/or PR positive invasive ductal breast cancer receiving zoledronic acid

Outcome Description:

We have identified 14 tumor biomarkers as primary endpoints and will control the false discover rate (FDR) among these by applying the sequential Bonferroni-type multiple testing procedure of Benjamini and Hochberg (1995).

Outcome Time Frame:

From baseline to the time of definitive surgery (day 21-24)

Safety Issue:

No

Principal Investigator

Joanne Mortimer

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center

Authority:

United States: Federal Government

Study ID:

10192

NCT ID:

NCT01409811

Start Date:

September 2012

Completion Date:

Related Keywords:

  • Estrogen Receptor-negative Breast Cancer
  • Estrogen Receptor-positive Breast Cancer
  • Invasive Ductal Breast Carcinoma
  • Progesterone Receptor-negative Breast Cancer
  • Progesterone Receptor-positive Breast Cancer
  • Stage IA Breast Cancer
  • Stage IB Breast Cancer
  • Stage II Breast Cancer
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Ductal, Breast

Name

Location
City of Hope Medical Center Duarte, California  91010