Paclitaxel, Doxorubicin, and Cyclophosphamide With Or Without Carboplatin in Treating Women With … (NCT00589238) | Clinical Trial Compass
TerminatedPhase 2
Paclitaxel, Doxorubicin, and Cyclophosphamide With Or Without Carboplatin in Treating Women With Locally Advanced Breast Cancer That Can Be Removed by Surgery
Singapore16 participantsStarted 2008-01
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, doxorubicin, cyclophosphamide, and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether combination chemotherapy is more effective with or without carboplatin in treating breast cancer.
PURPOSE: This randomized phase II trial is studying giving paclitaxel together with doxorubicin and cyclophosphamide to see how well it works compared to giving paclitaxel together with doxorubicin, cyclophosphamide, and carboplatin in treating women with locally advanced breast cancer that can be removed by surgery.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* Histologically confirmed invasive basal-type breast cancer meeting the following criteria:
* Newly diagnosed disease
* Locally advanced or operable primary disease \> 2 cm, without evidence of metastatic disease
* Clinical T2 (\> 2 cm), T3 (\> 5 cm), or T4 primary tumors with or without clinical lymph node involvement (N0-3)
* T4 tumors are defined by any of the following:
* Skin ulceration
* Satellite nodules
* Peau d' orange (skin edema)
* Chest wall invasion
* Inflammatory breast cancer
* Her-2/neu 0-1+ by IHC (or negative by fluorescent in situ hybridization if Her-2 2+ by immunohistochemistry)
* No metastatic disease
* Hormone receptor status:
* Estrogen and progesterone receptor-negative disease
PATIENT CHARACTERISTICS:
Inclusion criteria:
* Female
* Menopausal status not specified
* ECOG performance status (PS) 0-2 or Karnofsky PS 60-100%
* Life expectancy \> 10 years
* Leukocytes ≥ 3,000/μL
* Absolute neutrophil count ≥ 1,500/μL
* Platelets ≥ 100,000/μL
* Total bilirubin normal
* AST and ALT ≤ 2.5 times upper limit of normal
* Creatinine normal OR creatinine clearance ≥ 60 mL/min
* Not pregnant or nursing
* Fertile patients must use effective contraception
* Cardiac ejection fraction ≥ 50% as assessed by MUGA scan or 2D echocardiogram
Exclusion criteria:
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to paclitaxel, carboplatin, or other a…
What they're measuring
1
Pathological complete response rate
Timeframe: Pathological response will be assessed by evaluation of surgical specimen after completion of protocol treatment.