TerminatedPhase 2

Study Of Abraxane® And Carboplatin As First-Line Treatment For Triple Negative Metastatic Breast Cancer

Stopped: Low enrollment and there is insufficient data to publish.

United States, China10 participantsStarted 2011-08

Plain-language summary

Taxanes (such as paclitaxel) are highly active to treat breast cancer. Abraxane® (nanoparticle albumin-bound paclitaxel) compared to standard paclitaxel improves efficacy and tolerability. When combined with a taxane, platinum agents improve response in metastatic breast cancer, with carboplatin conferring less toxicity than cisplatin. The investigators hypothesize that the combination of weekly Abraxane® and carboplatin will lengthen time to progression without producing intolerable toxicity.

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.

Inclusion Criteria: * Patients with histologically or cytologically confirmed diagnosis of metastatic (Stage IV) breast cancer; * Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST); * "Triple negative" disease defined as "tumor demonstrating no expression for estrogen, progesterone or HER2 receptors." (No expression is categorized as ≤ 10% of cells staining or Allred ≤ 2); * Aged 18 years or older; * Eastern Cooperative Oncology Group (ECOG)ECOG/Zubrod performance status of 0 or 1; life expectancy ≥ 3 months; * No prior chemotherapy for metastatic disease. * At least 6 months must have elapsed since prior adjuvant chemotherapy. * Laboratory tests performed within 14 days of study entry showing: * Granulocytes ≥ 1,500/µL; * Platelets ≥ 100,000/µL; * Hemoglobin ≥ 9.0 gm/dL; * Total bilirubin ≤ institutional upper limit of normal (ULN); * Aspartate transaminase (AST) and alanine aminotransferase (ALT) ≤ 2.5 times ULN; * Alkaline phosphatase ≤ 5 times ULN; * Estimated creatinine clearance ≥ 60 mL/min. * Urine protein:creatinine ratio ≤ 1.0. or 24 hour urine protein collection demonstrating ≤ 1 gram of protein per 24 hours to be eligible. * left ventricular ejection fraction (LVEF) ≥ 50% by multiple gated acquisition scan (MUGA)/Echocardiogram; * Informed consent to receive protocol treatment: * Cognitive and communication skills adequate to comply with study and/or follow-up procedures; * Geographic proximity and ability to com…

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

PFS

Timeframe: PFS is defined as the interval from study registration to disease progression or death due to any cause, whichever comes first

Trial details

NCT IDNCT01207102

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-06

Results submitted2014-12-08

View on ClinicalTrials.gov More Metastatic Breast Cancer trials