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A Pre-operative Window Study of Letrozole Plus PR Agonist (Megestrol Acetate) Versus Letrozole Alone in Post-menopausal Patients With ER-positive Breast Cancer
Bu çalışma, menopoz sonrası, östrojen reseptörü pozitif (ER-positive) meme kanseri (breast cancer) olan kadınlarda, ameliyat öncesi kısa dönemde Letrozole ile birlikte bir progesteron reseptörü agonisti olan Megestrol Acetate'in, tek başına Letrozole ile karşılaştırılmasını incelemiştir. Çalışmaya, histolojik olarak doğrulanmış, ER pozitif ve HER2 negatif meme kanseri olan menopoz sonrası kadınlar alınmıştır. Çalışma Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Histologically confirmed breast adenocarcinoma * Postmenopausal women * Core biopsy confirmation of invasive carcinoma on core biopsy, ≥T1c, either clinical NX or N0-N3 * ER positive (Allred≥3) and HER2 negative * 2 groups of patients are potentially eligible: * Cohort A: Patients whose cancers have been deemed to be operable by the Multi-Disciplinary Team (MDT), with surgery planned for the next 2-6 weeks * Cohort B: Patients with early or locoregionally advanced breast cancer planned for primary endocrine therapy, either in lieu of surgery or as neoadjuvant therapy prior to surgery- such patients must begin PIONEER trial therapy prior to starting any other endocrine therapy. * ECOG performance status of 0, 1 or 2 * Adequate Liver, Renal and Bone marrow function, defined as: * Adequate liver function where bilirubin is ≤1.5 x ULN * Adequate renal function with serum creatinine ≤ 1.5 x ULN * Adequate bone marrow function with ANC ≥1.0 x 10\*9/L and Platelet count ≥100 x 10\*9/L * Written informed consent to participate in the trial and to donation of tissue Exclusion Criteria: * History of hormone replacement therapy in the last 6 months * Previous treatment with Tamoxifen or an aromatase inhibitor in the last six months * Known hypersensitivity or contraindications to aromatase inhibitors or Megestrol acetate * Known allergy to lactose * Known to have a progestogen-containing intrauterine system in situ, unless removed prior to randomisation * Known metastatic disease on presentation * Recurrent breast cancer (patients with a new primary invasive breast cancer will be eligible to participate) * Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the trial, at the discretion of the investigator * Treatment with an investigational drug within 4 weeks before randomisation * Inability to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the trial medication * Inability to give informed consent