Stage I Breast CancerPhase 2NCT01194427

A Study of Vorinostat and Tamoxifen in Newly Diagnosed Breast Cancer

A Phase 2 study testing Vorinostat and Tamoxifen in people with Stage I Breast Cancer and Stage II Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 research study is designed to look at the effects of the combination of vorinostat (Suberoylanilide Hydroxamic Acid or Zolinza) and tamoxifen on breast cancer tissue. The investigators will do this by comparing tissues from the original breast biopsy to tissues obtained after taking vorinostat and tamoxifen for 2… Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer
What is being tested?: Vorinostat and Tamoxifen
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: Mar 2011to Nov 2011
Phase: Phase 2
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 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Stage I-III invasive breast cancer
Awaiting surgery or neoadjuvant treatment
ECOG performance status 0, 1 or 2
Adequate organ function
Prior use of hormone contraception or replacement therapy must have been discontinued at least 30 days prior to diagnostic biopsy (unless participant is willing to undergo an additional biopsy for the study)

Who cannot join

Prior or current treatment of any kind for the current breast cancer
Current use of any other investigational drugs
Uncontrolled or active infection, congestive heart failure, cardiac arrythmia, or psychiatric illness

Trial locations and contacts

1 site in 1 country.

United States1 site

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: A Multi-Institutional Phase II Study Evaluating Surrogate Biomarkers of Response to Short Term Oral Vorinostat and Tamoxifen in Women With Newly Diagnosed Breast Cancer

Read the detailed description

Key eligibility criteria include:

Newly diagnosed invasive breast cancer awaiting surgery or neoadjuvant (preoperative) treatment
No use of hormone contraceptives or replacement therapy within 30 days prior to the diagnostic breast cancer biopsy (unless willing to have an additional biopsy prior to starting the study)
No prior or current use of any therapy to treat the current breast cancer.

Conditions: Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer, Invasive Breast Cancer
Being tested: Vorinostat and Tamoxifen
Keywords: Preoperative, Neoadjuvant
Medical subject headings: Breast Neoplasms

What participants receive

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

Vorinostat and TamoxifenDrug
Also called Zolinza
vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily for 14 days

Study groups in NCT01194427
Study group	Role	What they receive
Vorinostat and Tamoxifen	Experimental	Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery. Receives: Drug: Vorinostat and Tamoxifen

What is being measured

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

Changes in Markers of Proliferation Prior to and After Study Drug Administration
To determine the percentage change in proliferation index Ki-67 in both ER-positive and ER-negative tumors between baseline and post-treatment biopsy following 14 days of vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily in women with primary breast cancer awaiting definitive surgery.
Measured: Baseline and 14 days

Timeline

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

Mar 2011Nov 2011

First posted3 Sep 2010 (estimated)
Study startMar 2011
Primary completionNov 2011
Study completionNov 2011

Why it stopped: Difficulty meeting patient accrual goals

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 Stage I Breast CancerStudies of the same condition, open and under way.
More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe 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 2
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01194427
Sponsor's protocol ID: J09144
Other IDs: NA_00033768
Status last verified: May 2013
First submitted: 25 Mar 2010
Last updated: 17 May 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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Study at a glance

From the registry record, last updated by the sponsor on 17 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-Institutional Phase II Study Evaluating Surrogate Biomarkers of Response to Short Term Oral Vorinostat and Tamoxifen in Women With Newly Diagnosed Breast Cancer
ClinicalTrials.gov ID: NCT01194427
Acronym / sponsor ID: J09144
Conditions: Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer, Invasive Breast Cancer
Keywords: Preoperative, Neoadjuvant
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Difficulty meeting patient accrual goals
Enrolment: 2 participants (actual)
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
Collaborators: Merck Sharp & Dohme LLC
Study start: Mar 2011
Primary completion: Nov 2011 (actual)
Study completion: Nov 2011 (actual)
First posted: 3 Sep 2010 (estimated)
Results: Posted 17 May 2013

Clinical summary

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

Detailed description

Key eligibility criteria include:

Newly diagnosed invasive breast cancer awaiting surgery or neoadjuvant (preoperative) treatment
No use of hormone contraceptives or replacement therapy within 30 days prior to the diagnostic breast cancer biopsy (unless willing to have an additional biopsy prior to starting the study)
No prior or current use of any therapy to treat the current breast cancer.

Study design

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

Arm	Type	Receives
Vorinostat and Tamoxifen	Experimental	Drug: Vorinostat and TamoxifenVorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Stage I-III invasive breast cancer
Awaiting surgery or neoadjuvant treatment
ECOG performance status 0, 1 or 2
Adequate organ function
Prior use of hormone contraception or replacement therapy must have been discontinued at least 30 days prior to diagnostic biopsy (unless participant is willing to undergo an additional biopsy for the study)

Key exclusion criteria (3 listed)

Prior or current treatment of any kind for the current breast cancer
Current use of any other investigational drugs
Uncontrolled or active infection, congestive heart failure, cardiac arrythmia, or psychiatric illness

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
Vorinostat and TamoxifenAlso: Zolinzavorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily for 14 days	Drug	Vorinostat and Tamoxifen

Primary outcome

Changes in Markers of Proliferation Prior to and After Study Drug Administration
Time frame: Baseline and 14 days
To determine the percentage change in proliferation index Ki-67 in both ER-positive and ER-negative tumors between baseline and post-treatment biopsy following 14 days of vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily in women with primary breast cancer awaiting definitive surgery.

Results and safety

Results posted to the registry on 17 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Vorinostat and Tamoxifen	2	2

Primary outcome: Changes in Markers of Proliferation Prior to and After Study Drug Administration

Time frame: Baseline and 14 days

Population analysed: Two (2) participants were enrolled; however, due to difficulty in recruitment, we were not able to complete the study. There were not study-specific analyses completed or results to report.

Adverse events

Time frame: 14 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Vorinostat and Tamoxifen	0 of 2 (0%)	2 of 2 (100%)	Not reported

Limitations and caveats (from the sponsor): Unable to recruit participants to complete the study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Vered Stearns, M.D. principal investigator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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 3 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 17 May 2013. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 May 2013). 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?

Changes in Markers of Proliferation Prior to and After Study Drug Administration (time frame: Baseline and 14 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 NCT01194427.

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 17 May 2013.