Active — Not RecruitingPhase 2

Carboplatin and Nab-Paclitaxel With or Without Vorinostat in Treating Women With Newly Diagnosed Operable Breast Cancer

United States68 participantsStarted 2008-05

Plain-language summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Vorinostat may also help carboplatin and paclitaxel albumin-stabilized nanoparticle formulation work better by making tumor cells more sensitive to the drugs. Giving chemotherapy with or without vorinostat before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This randomized phase II trial is studying how well giving carboplatin together with paclitaxel albumin-stabilized nanoparticle formulation works with or without vorinostat in treating women with breast cancer that can be removed by surgery.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 whi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pathological Complete Response (pCR) Rate

Timeframe: Time of breast cancer surgery

Trial details

NCT IDNCT00616967

SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06

Results submitted2014-04-08

View on ClinicalTrials.gov More Breast Cancer trials