Could adding vorinostat to chemo shrink breast tumors better before surgery?
NCT ID NCT00616967
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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68 people
The number who actually took part.
- Start date
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May 2008
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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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
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Anne Arundel Health System
Annapolis, Maryland, 21401, United States
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Indiana University Purdue University of Indianapolis
Indianapolis, Indiana, 46202, United States
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Mayo Clinic Cancer Center
Rochester, Minnesota, 55905, United States
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Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410, United States
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University of Alabama Comprehensive Cancer Center
Birmingham, Alabama, 35249, United States
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Other studies related to the condition(s) this trial covers.
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