Meme Kanserinde Docetaxel-Capecitabine ve Doxorubicin-Cyclophosphamide ile Birincil Kemoterapi

Sade dilde özet

Bu çalışma, meme kanseri (breast cancer) olan hastalarda Docetaxel, Capecitabine, Doxorubicin ve Cyclophosphamide gibi ilaçlarla uygulanan birincil kemoterapiyi incelemiştir. Çalışmaya, tümör boyutu 2 cm'den büyük, evre II veya III meme kanseri olan, 18 yaş ve üzeri hastalar katılabilmiştir. Çalışma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

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Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Tamamlandı

Sponsor

National Cancer Institute (NCI)

Müdahale

Docetaxel - Dose A, Anastrozole, cyclophosphamide, Docetaxel - Dose B, Doxorubicin hydrochloride, Tamoxifen Citrate, Capecitabine - Dose B, Capecitabine - Dose A

Başlangıç

01.06.2000

Tahmini bitiş

01.01.2008

Ülkeler

United States

İlgili genler

Merkezler

• Bethesda, United States

Uygunluk kriterleri

Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.

* INCLUSION CRITERIA:

Stage II or III breast cancer with a tumor size of greater than 2 cm. Patients with a previous biopsy are eligible provided adequate tumor tissue remains for biopsy in this study.

At least 18 years of age.

Adequate hematopoietic function as defined by absolute neutrophil count greater than 1200/mm\^3 and platelet count greater than 100,000/mm\^3.

Adequate renal function as defined by creatinine less than 1.6 mg/dL.

Adequate hepatic function as defined by total (T.) bilirubin less than 1.4 mg/dL and serum glutamic oxaloacetic transaminase (SGOT)/serum glutamic pyruvic transaminase (SGPT) less than 1.5 times the upper limit of normal and alkaline phosphatase less than 2.5 times upper limit of normal

Zubrod Performance status 0-2.

EXCLUSION CRITERIA:

Medical or psychiatric condition that, in the opinion of the Principal Investigator, would preclude chemotherapy administration. Patients may be evaluated by psychiatry or medical subspecialties as appropriate.

Pregnant or lactating women

Known bleeding disorders

Hypersensitivity to Tween 80 (Polysorbate)

Cardiac ejection fraction below normal limits, myocardial infarction within the past 12 months, or symptomatic arrhythmia requiring medical intervention.

Prior chemotherapy or hormonal therapy for breast cancer. Patients treated with hormonal chemoprevention (tamoxifen or raloxifene) will be eligible.

Active malignancy diagnosed within the last 5 years. (Cervical cancer or non-melanomatous skin cancer that has been treated with curative intent will be eligible).