HER2 Pozitif Meme Kanseri Olan Katılımcılarda MYOCET (Lipozomal Doksorubisin) ile Kombinasyon Tedavisi

Sade dilde özet

Bu çalışma, HER2 pozitif Evre II veya III meme kanseri olan hastalarda MYOCET (lipozomal doksorubisin) ilacını Siklofosfamid, Trastuzumab ve Dosetaksel ile kombinasyon halinde inceliyor. Daha önce tedavi görmemiş, HER2 fazlalığı doğrulanmış 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

Cephalon, Inc.

Müdahale

Liposomal doxorubicin hydrochloride, Cyclophosphamide, Trastuzumab, Free doxorubicin hydrochloride, Docetaxel

Başlangıç

13.10.2008

Tahmini bitiş

17.09.2015

Ülkeler

Austria, Belgium, France, Germany, Italy, Spain

İlgili genler

Merkezler

• Kufstein, Austria
• Vienna, Austria
• Brussels, Belgium
• Yvoir, Belgium
• Clichy, France
• Nancy, France
• Reims, France
• Vandœuvre-lès-Nancy, France
• Aachen, Germany
• Düsseldorf, Germany
• Düsseldorf, Germany
• Essen, Germany
• Loerrach, Germany
• München, Germany
• München, Germany
• Naples, Italy
• Roma, Italy
• Verona, Italy
• Barcelona, Spain
• Barcelona, Spain
• Lleida, Spain
• Zaragoza, Spain

Uygunluk kriterleri

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

Main Inclusion Criteria:

* Treatment-naive participants with stage II or III invasive breast cancer (proven histologically/cytologically) and with tests showing an overexpressing of HER2.
* Participants have at least 1 bidimensionally measurable lesion according to the World Health Organization (WHO) criteria.
* The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* The participant has an LVEF of at least 55% as assessed by multigated acquisition (MUGA) scan (preferred) or echocardiography.
* The participant has hematology and serum chemistry laboratory test results within specific protocol-defined ranges.
* Women of childbearing potential must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the treatment period and for 6 months after the last administration of study drug.

Main Exclusion Criteria:

The participant:

* Has received previous cancer therapy for breast cancer.
* Has any history of CHF, angina pectoris, or myocardial infarction.
* Has uncontrolled hypertension.
* Has infection, peptic ulcer, or unstable diabetes mellitus.
* Has been treated with live virus vaccines within 8 weeks before the first administration of study drug.
* Has impaired hepatic or renal function.
* Is a pregnant or lactating woman. (Any women becoming pregnant during the study will be withdrawn from the study.)
* Has used an investigational drug within one month before the screening visit.
* Has a known hypersensitivity to any of the study drugs or to their active ingredients.
* Has an inflammatory breast cancer.
* Has had any other malignancies within five years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer).

Note: Other inclusion and exclusion criteria may apply.