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Could adding vorinostat to chemo shrink breast tumors better before surgery?

NCT ID NCT00616967

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether adding a drug called vorinostat to standard chemotherapy (carboplatin and nab-paclitaxel) before surgery helps shrink tumors more in women with HER2-negative breast cancer. About 68 women took part. The goal was to see if the combination leads to no cancer left in the breast or lymph nodes at the time of surgery, potentially allowing for less tissue removal.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

68 people

The number who actually took part.

Start date

May 2008

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

DISEASE CHARACTERISTICS: * Histologically confirmed infiltrating ductal breast cancer by core needle biopsy * Mixed ductal and lobular disease allowed * Infiltrating lobular cancer allowed in the run-in portion only * Unresected, clinically measurable disease, meeting 1 of the following clinical staging criteria: * T2, T3, or T4 lesion, any N, M0 * T1c, N1-3,M0 * Patients with skin metastases to the ipsilateral breast for whom chemotherapy is planned prior to definitive surgery are eligible for the primary study portion * HER2-negative disease * Hormone receptor status\* meeting 1 of the following criteria: * Estrogen receptor (ER)-negative and progesterone receptor (PR)-negative * ER-positive (grade II or III) and PR-positive or PR-negative NOTE: \*Any ER or PR status for the run-in portion PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Menopausal status not specified * ANC ≥ 1,500/mm³ * Platelet count ≥ 150,000/mm³ * Hemoglobin ≥ 9 g/dL * Creatinine ≤ 1.5 times the upper limit of normal (ULN) * Creatinine clearance ≥ 50 mL/min * Total bilirubin normal * AST(SGOT) and ALT(SGPT) ≤ 2.5 times (ULN) * alkaline phosphatase ≤ 2.5 times ULN * PT such that INR ≤ 1.5 (or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of therapeutic warfarin) and PTT ≤ ULN * Adequate cardiac function defined as no evidence of PR prolongation or AV block on baseline electrocardiogram (ECG) * Willing to use effective, non-hormonal contraception while on treatment and for at least 3 months thereafter * Not pregnant or nursing * No pre-existing peripheral neuropathy ≥ grade 2 * No history of severe hypersensitivity reaction to any drug formulated with polysorbate 80 or to E. coli-derived products * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat * No medical condition which, in the opinion of the investigator, puts the patient at risk of potentially serious complications while on this therapy PRIOR CONCURRENT THERAPY: * At least 4 weeks since prior valproic acid or other histone deacetylase inhibitor * No prior chemotherapy, radiotherapy, or endocrine therapy for this cancer * Prior tamoxifen or raloxifene or another agent for prevention of breast cancer allowed as long as the patient has discontinued the treatment ≥ 1 month prior to baseline study biopsy * No systemic treatment for prior cancer within the past 5 years (primary study portion) * No prior or ongoing systemic treatment for this cancer (primary study portion) * No concurrent combination antiretroviral therapy for HIV-positive patients * No other concurrent histone deacetylase inhibitor * No other concurrent chemotherapy, antiestrogen therapy, radiotherapy, or other investigational systemic therapy * No other concurrent biologic therapy * No other concurrent investigational drugs

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Anne Arundel Health System

    Annapolis, Maryland, 21401, United States

  • Indiana University Purdue University of Indianapolis

    Indianapolis, Indiana, 46202, United States

  • Mayo Clinic Cancer Center

    Rochester, Minnesota, 55905, United States

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231-2410, United States

  • University of Alabama Comprehensive Cancer Center

    Birmingham, Alabama, 35249, United States

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