Biomarkers in Tissue Samples From Patients With Newly Diagnosed Breast Cancer Treated With Zoledronic Acid
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|ClinicalTrials.gov Identifier: NCT01409811|
Recruitment Status : Terminated (Study closed after it became too difficult to interest patients in participating.)
First Posted : August 4, 2011
Results First Posted : April 28, 2020
Last Update Posted : May 8, 2020
|Condition or disease||Intervention/treatment||Phase|
|Estrogen Receptor-positive Breast Cancer Invasive Ductal Breast Carcinoma Progesterone Receptor-positive Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer||Drug: zoledronic acid Other: laboratory biomarker analysis Procedure: therapeutic conventional surgery||Not Applicable|
I. To evaluate 14 tumor biomarkers of growth and metastasis (10 by microarray and 4 by RT-PCR) for change in response to ZA.
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 10-23 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 10-23. Tissue and blood 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.
After completion of study treatment, patients are followed up at 40-44 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of the Impact of a Single Dose of Zoledronic Acid on Biomarkers in Breast Cancer|
|Study Start Date :||September 14, 2012|
|Actual Primary Completion Date :||January 1, 2015|
|Actual Study Completion Date :||February 2015|
Experimental: Treatment (zoledronic acid)
Patients receive a single dose of zoledronic acid 4 mg IV over 15 minutes on day 1. Patients then undergo planned definitive surgery (lumpectomy or mastectomy) on day 10-23. Tissue and blood 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.
zoledronic acid: Given IV
laboratory biomarker analysis: Correlative studies
therapeutic conventional surgery: Undergo definitive lumpectomy or mastectomy
Drug: zoledronic acid
Other: laboratory biomarker analysis
Procedure: therapeutic conventional surgery
Undergo definitive lumpectomy or mastectomy
- Mean (SE) Change From Pre-Treatment Baseline in (Log)pg/mL of Biomarker, by Time, Adjusted for Level at Baseline [ Time Frame: "48-72 hrs" and "Surgery (10-23 days)" ]After the trial's premature closure, no data were collected for the primary endpoints; however, data on 14 of 30 secondary endpoints were obtained and are summarized below. Serum level (pg/mL) per biomarker was log-transformed. Change from baseline over time was evaluated using a generalized linear mixed model where follow-up time was represented by terms for the sequence of post-baseline samples or for (log)day on study. To recognize regression to the mean across repeated samples, a term for biomarker level at baseline, with or without interaction by time, was included when it improved the model's fit to the observed data. With 14 biomarkers sampled twice after baseline, there were 28 evaluations of change in biomarker level with exposure to study drug. Therefore, to control the False Discovery Rate (FDR), only evaluations that maintained the study's FDR at no more than 5 percent were accepted as true.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01409811
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|Principal Investigator:||Joanne Mortimer||City of Hope Medical Center|