Evre II/III Meme Kanseri (Kadınlar) Tedavisinde Paklitaksel, Siklofosfamid ve Doksorubisin, Otolog Dendritik Hücreler ve Cerrahi

Sade dilde özet

Bu çalışma, Evre II/III meme kanseri olan kadınlarda kemoterapi (Paklitaksel, Siklofosfamid, Doksorubisin), hastanın kendi bağışıklık hücrelerinden hazırlanan dendritik hücre aşısı ve cerrahiyi birlikte inceliyor. HER2 negatif, 3 cm veya daha büyük tümörü olan hastalar dahil edilmiştir. Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.

Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Tamamlandı

Sponsor

University of Nebraska

Müdahale

therapeutic autologous dendritic cells, aromatase inhibition therapy, cyclophosphamide, doxorubicin hydrochloride, paclitaxel, tamoxifen citrate, gene expression analysis, protein expression analysis, reverse transcriptase-polymerase chain reaction, immunoenzyme technique, immunohistochemistry staining method, laboratory biomarker analysis, adjuvant therapy, biopsy, conventional surgery, neoadjuvant therapy, radiation therapy

Başlangıç

01.05.2006

Tahmini bitiş

28.01.2010

Ülkeler

United States

İlgili genler

Merkezler

• Tampa, United States
• Omaha, United States

Uygunluk kriterleri

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

Inclusion Criteria:

* Histologically confirmed invasive breast cancer meeting the following criteria:

  * Primary tumor ≥ 3 cm by mammography, ultrasound, or palpation AND/OR palpable axillary lymph nodes \> 1 cm
  * Survivin- and/or carcinoembryonic antigen-positive by IHC
  * Tumor must be localized by exam or ultrasound to allow tumor injection
  * No stage IV or metastatic disease
* HER2/neu-negative tumor by IHC

  o If 2+ or in the indeterminate range, further testing of HER2/neu overexpression by fluorescent in situ hybridization (FISH) is required
* Hormone receptor status known
* Female
* Pre-, peri-, or postmenopausal
* ECOG performance status 0-1
* Fertile patients must use effective contraception during and for up to 6 months following completion of study therapy
* ANC ≥ 1,500/mm³
* Platelet count ≥ 100,000/mm³
* Alkaline phosphatase ≤ 1.5 times upper limit of normal (ULN)
* Total bilirubin ≤ 1.5 times ULN
* AST and ALT ≤ 1.5 times ULN
* Creatinine \< 1.5 times ULN

Exclusion Criteria:

* No prior chemotherapy or radiotherapy
* No active serious infections
* No prior malignancy except adequately treated basal cell or squamous cell skin cancer, noninvasive carcinoma, or other cancer from which the patient has been disease free for 5 years
* No comorbidity or condition that would interfere with study assessments and procedures or preclude study participation
* Not pregnant or nursing/negative pregnancy test