Menopoz Sonrası ER+/HER2- İleri Meme Kanseri Kadınların İlk Basamak Tedavisinde Palbosiklib (PD-0332991) + Letrozolün Letrozolle Karşılaştırılması (PALOMA-2)

Sade dilde özet

Bu çalışma (PALOMA-2), östrojen reseptörü pozitif, HER2 negatif ileri meme kanseri olan menopoz sonrası kadınlarda ilk basamak tedavi olarak Palbosiklib + Letrozol tedavisini, tek başına Letrozolle karşılaştırıyor. Daha önce ileri hastalık için sistemik tedavi almamış hastalar dahil edilmiştir. Faz 3 aşamasında yürütülmüş ve tamamlanmıştır.

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

Deney bilgileri

Faz

Faz 3 (Phase 3)

Durum

Tamamlandı

Sponsor

Pfizer

Müdahale

PD-0332991, Letrozole, Placebo, Letrozole

Başlangıç

22.02.2013

Tahmini bitiş

09.11.2023

Ülkeler

United States, Australia, Belgium, Canada, Czechia, France, Germany, Hungary, Ireland, Italy, Japan, Poland, Russia, South Korea, Spain, Taiwan, Ukraine, United Kingdom

İlgili genler

Merkezler

• Bellflower, United States
• Beverly Hills, United States
• Fullerton, United States
• Glendale, United States
• Irvine, United States
• Laguna Hills, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Los Angeles, United States
• Pasadena, United States
• Redondo Beach, United States
• San Diego, United States
• San Francisco, United States
• San Francisco, United States
• San Luis Obispo, United States
• Santa Maria, United States
• Santa Monica, United States
• Stanford, United States
• West Hills, United States
• Westlake Village, United States
• Grand Junction, United States
• New Haven, United States
• Norwalk, United States
• Washington D.C., United States
• Deerfield Beach, United States
• Hollywood, United States
• Hollywood, United States

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Uygunluk kriterleri

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

Inclusion Criteria:

* Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy.
* Confirmed diagnosis of ER positive breast cancer
* No prior systemic anti-cancer therapy for advanced ER+ disease.
* Postmenopausal women
* Measurable disease as per Response Evaluation Criterion in Solid Tumors \[RECIST\] or bone-only disease
* Eastern Cooperative Oncology Group \[ECOG\] 0-2
* Adequate organ and marrow function
* Patient must agree to provide tumor tissue

Exclusion Criteria:

* Confirmed diagnosis of HER2 positive disease
* Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term
* Known uncontrolled or symptomatic CNS metastases
* Prior (neo)adjuvant treatment with letrozole or anastrozole with DFI ≤ 12-months from completion of treatment.
* Prior treatment with any CDK 4/6 inhibitor.