Estrogen Receptor-positive Breast CancerNCT01409811

Biomarkers in Tissue Samples From Patients With Newly Diagnosed Breast Cancer Treated With Zoledronic Acid

A study testing zoledronic acid, laboratory biomarker analysis and therapeutic conventional surgery in people with Estrogen Receptor-positive Breast Cancer and Invasive Ductal Breast Carcinoma, run by City of Hope Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This pilot clinical trial studies biomarkers in tissue samples from patients with newly diagnosed breast cancer treated with zoledronic acid (ZA). Studying samples of tumor tissue in the laboratory from patients receiving ZA may help doctors learn more about the effects of ZA on cells. Read more about this study

Who is it for?: Any age, women only
Conditions the study is for: Estrogen Receptor-positive Breast Cancer, Invasive Ductal Breast Carcinoma, Progesterone Receptor-positive Breast Cancer
What is being tested?: zoledronic acid, laboratory biomarker analysis and therapeutic conventional surgery
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: 20 Feb 2013to 1 Feb 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Postmenopausal women
Diagnosis of early stage, invasive ductal carcinoma (for which a lumpectomy or mastectomy is planned prior to systemic therapy)
Estrogen receptor (ER)/progesterone receptor (PR) positive tumor (as confirmed by City of Hope Pathology Department if done on the outside) or
Biopsy proven ER/PR positive tumor
Ability to provide informed consent

Who cannot join

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, with the exception of a baby aspirin regimen per principal investigator's (PI's) discretion
Renal impairment as determined by a creatinine clearance < 60 ml/min as calculated by the Cockcroft-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)

Trial locations and contacts

1 site in 1 country.

United States1 site

City of Hope Medical Center
Duarte, California, 91010

Other trials in United States

About this study

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

Read the detailed description

PRIMARY OBJECTIVES:

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:

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.

Conditions: 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
Being tested: zoledronic acid, laboratory biomarker analysis, therapeutic conventional surgery
Medical subject headings: Carcinoma, Ductal, Breast, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

zoledronic acidDrug
Also called CGP 42446, CGP42446A, NDC-zoledronate, zoledronate
Given IV
laboratory biomarker analysisOther
Correlative studies
therapeutic conventional surgeryProcedure or surgery
Undergo definitive lumpectomy or mastectomy

Study groups in NCT01409811
Study group	Role	What they receive
Treatment (zoledronic acid)	Experimental	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 Receives: Drug: zoledronic acid; Other: laboratory biomarker analysis; Procedure: therapeutic conventional surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean (SE) Change From Pre-Treatment Baseline in (Log)pg/mL of Biomarker, by Time, Adjusted for Level at Baseline
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.
Measured: "48-72 hrs" and "Surgery (10-23 days)"

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Feb 20131 Feb 2015

First posted4 Aug 2011 (estimated)
Study start20 Feb 2013
Primary completion1 Jan 2015
Study completion1 Feb 2015

Why it stopped: Study closed after it became too difficult to interest patients in participating.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Estrogen Receptor-positive Breast CancerStudies of the same condition, open and under way.
More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01409811
Sponsor's protocol ID: 10192
Other IDs: NCI-2011-02137
Status last verified: Oct 2026
First submitted: 3 Aug 2011
Last updated: 5 Nov 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
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Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery
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All Estrogen Receptor-positive Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Study of the Impact of a Single Dose of Zoledronic Acid on Biomarkers in Breast Cancer
ClinicalTrials.gov ID: NCT01409811
Acronym / sponsor ID: 10192
Conditions: 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
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study closed after it became too difficult to interest patients in participating.
Enrolment: 9 participants (actual)
Lead sponsor: City of Hope Medical CenterUniversity, hospital or other
Collaborators: National Cancer Institute (NCI)
Study start: 20 Feb 2013 (actual)
Primary completion: 1 Jan 2015 (actual)
Study completion: 1 Feb 2015 (actual)
First posted: 4 Aug 2011 (estimated)
Results: Posted 28 Apr 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

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:

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.

After completion of study treatment, patients are followed up at 40-44 days.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment (zoledronic acid)	Experimental	Drug: zoledronic acid, Other: laboratory biomarker analysis, Procedure: therapeutic conventional surgeryPatients 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

Who may qualify

Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (5 listed)

Postmenopausal women
Diagnosis of early stage, invasive ductal carcinoma (for which a lumpectomy or mastectomy is planned prior to systemic therapy)
Estrogen receptor (ER)/progesterone receptor (PR) positive tumor (as confirmed by City of Hope Pathology Department if done on the outside) or
Biopsy proven ER/PR positive tumor
Ability to provide informed consent

Key exclusion criteria (7 listed)

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, with the exception of a baby aspirin regimen per principal investigator's (PI's) discretion
Renal impairment as determined by a creatinine clearance < 60 ml/min as calculated by the Cockcroft-Gault formula using the patient's actual weight

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
zoledronic acidAlso: CGP 42446, CGP42446A, NDC-zoledronate, zoledronateGiven IV	Drug	Treatment (zoledronic acid)
laboratory biomarker analysisCorrelative studies	Other	Treatment (zoledronic acid)
therapeutic conventional surgeryUndergo definitive lumpectomy or mastectomy	Procedure or surgery	Treatment (zoledronic acid)

Primary outcome

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.

Results and safety

Results posted to the registry on 28 Apr 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment (Zoledronic Acid)	9	8

Primary outcome: 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)". Mean (Standard Error). Unit: (log)pg/mL

Measure	Treatment (Zoledronic Acid) n = 8
MIG @ 48-72 hrs	2.31 (0.24)
MIG @ Surgery (Day 10-23)	0.62 (0.14)
IP-10 @ 48-72 hrs	1.47 (0.18)
IP-10 @ Surgery (Day 10-23)	0.16 (0.08)
IL-12 @ 48-72 hrs	0.23 (0.06)
IL-12 @ Surgery (Day 10-23)	-0.01 (0.05)
Eotaxin @ 48-72 hrs	-0.23 (0.06)
Eotaxin @ Surgery (Day 10-23)	0.02 (0.06)

Population analysed: The analysis included data from all evaluable subjects.

Adverse events

Time frame: Adverse events collected over a period of 2 years and 3 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment (Zoledronic Acid)	0 of 9 (0%)	8 of 9 (88.9%)	0 of 9

Limitations and caveats (from the sponsor): Results shown come from the 8 evaluable subjects enrolled before early closure of the trial, originally planned to include 40 subjects.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Estrogen Receptor-positive Breast Cancer

RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Recruiting
Short-Term Reduced Dietary Protein in ER+/HER2- Breast Cancer Patients During Neoadjuvant Chemotherapy
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Active, not recruitingObservational study
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Not yet recruiting
Prospective Study to Evaluate the Clinical Utility of ctDNA Tumor Fraction (TF) for Detection of Estrogen Receptor 1 (ESR1) Mutations in (Human Epidermal Growth Factor Receptor) HR+/HER2- Metastatic Breast Cancer (MBC)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joanne Mortimer principal investigator

City of Hope Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)"). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01409811.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.