Hormonal Tedaviye Duyarlı Meme Kanseri Hastalarında Trastuzumab, Pertuzumab ve Letrozole ile Ameliyat Öncesi Çalışma

Sade dilde özet

Bu çalışma, ameliyat öncesinde Trastuzumab, Pertuzumab ve Letrozole tedavilerini, hormonal tedaviye duyarlı meme kanseri (breast cancer) hastalarında incelemiştir. Çalışmaya, hormon reseptörü ve HER2 pozitif, evre II-IIIA, menopoz sonrası kadın hastalar dahil edilmiştir. Çalışma 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

Istituto Oncologico Veneto IRCCS

Müdahale

Pertuzumab

Başlangıç

01.02.2014

Tahmini bitiş

12.01.2018

Ülkeler

Italy

İlgili genler

Merkezler

• Catania, Italy
• Cona, Italy
• Milan, Italy
• Milan, Italy
• Piacenza, Italy
• Padova, Italy
• Reggio Emilia, Italy
• Udine, Italy

Uygunluk kriterleri

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

Inclusion Criteria:

* primary diagnosis of infiltrating breast cancer
* HR positivity (ER ≥ 10% and/or PgR ≥10%) and HER2 positivity (IHC 3+ or FISH/CISH amplification), as assessed by local laboratory.
* Stage II-IIIA
* age \>18 yrs
* ECOG Performance Status 0-1
* Postmenopausal status, defined by at least one of the following:

  60 years of age; \< 60 years of age and amenorrheic for \>/=12 months prior to day 1 \< 60 years of age, without a uterus, and luteinizing hormone (LH) and follicle stimulating hormone (FSH) values within postmenopausal range Prior bilateral oophorectomy Prior radiation castration with amenorrhea for at least 6 months
* Cardiac ejection fraction within the institutional range of normal (as measured by echocardiogram or MUGA scan).
* Normal organ and marrow function as defined below:

(leukocytes \>=3000/mcL; absolute neutrophil count \>=1,500/mcL; platelets \>=100,000/mcL; total bilirubin within 1.25 x normal institutional limits (with the exception of Gilbert's syndrome); AST (SGOT)/ALT(SGPT) within 1.25 x institutional upper limit of normal creatinine within normal institutional limits

* Availability of tumor tissue suitable for biological and molecular examination before starting primary treatment
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Stage IIIB, IIIC, and inflammatory breast cancer
* Stage IV breast cancer
* Prior treatment with chemotherapy, endocrine therapy or radiotherapy. Prior treatment with HER2 targeting therapies
* LVEF below the ULN
* Uncontrolled hypertension (systolic \>150 mm Hg and/or diastolic \>100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident (CVA)/stroke or myocardial infarction within 6 months prior to first study medication, unstable angina, congestive heart failure (CHF) of New York Heart Association (NYHA) grade II or higher, or serious cardiac arrhythmia requiring medication.
* Received any investigational treatment within 4 weeks of study start.
* Subjects with known infection with HIV, HBV, HCV
* Known hypersensitivity to any of the study drugs or excipients.
* Dyspnoea at rest or other disease requiring continuous oxygen therapy.
* Psychiatric illness/social situations that would limit compliance with study requirements
* Subjects assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol