Hormon Reseptörü Pozitif, HER2 Negatif, Luminal Meme Kanserinde Neoadjuvan Tedavinin Kişiselleştirilmesi

Sade dilde özet

Bu çalışma, hormon reseptörü pozitif, HER2 negatif luminal meme kanseri (luminal breast cancer) olan hastalarda ameliyat öncesi (neoadjuvan) tedavinin kişiselleştirilmesini; Letrozole, kemoterapi ve Ribociclib ile Letrozole kombinasyonunu değerlendirmektedir. Çalışmaya, evre II/III meme kanseri bulunan postmenopozal kadınlar katılmaktadır. Çalışma Faz 2 aşamasında yürütülmekte; şu an katılımcı almamakta ancak devam etmektedir (active, not recruiting).

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

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Devam ediyor, katılım kapalı

Sponsor

Borstkanker Onderzoek Groep

Müdahale

Letrozole, Chemotherapy, Ribociclib plus letrozole

Başlangıç

15.06.2019

Tahmini bitiş

01.08.2027

Ülkeler

Netherlands

İlgili genler

Merkezler

• 's-Hertogenbosch, Netherlands
• Almelo, Netherlands
• Amstelveen, Netherlands
• Amsterdam, Netherlands
• Amsterdam, Netherlands
• Apeldoorn, Netherlands
• Breda, Netherlands
• Delft, Netherlands
• Deventer, Netherlands
• Eindhoven, Netherlands
• Eindhoven, Netherlands
• Gouda, Netherlands
• Haarlem, Netherlands
• Harderwijk, Netherlands
• Hilversum, Netherlands
• Hoorn, Netherlands
• Leiden, Netherlands
• Maastricht, Netherlands
• Nijmegen, Netherlands
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• Sneek, Netherlands
• The Hague, Netherlands
• The Hague, Netherlands
• Tiel, Netherlands
• Tilburg, Netherlands
• Venlo, Netherlands
• Winterswijk, Netherlands
• Zwolle, Netherlands

Uygunluk kriterleri

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

Inclusion Criteria:

* Postmenopausal women presenting with histological proven (core biopsy material) hormone receptor positive (ER≥50%, PR any), HER2 negative, stage II/ III breast cancer.
* Measurable disease (breast and/or lymph nodes)
* WHO 0-2
* Adequate bone marrow function (within 4 weeks prior to registration): WBC≥3.0x109/l, neutrophils ≥1.5 x 109/l, platelets ≥100 x 109/l
* Adequate liver function (within 4 weeks prior to registration): bilirubin ≤1.5 x upper limit of normal (UNL) range, ALAT and/or ASAT ≤2.5 x UNL, Alkaline Phosphatase ≤5 x UNL
* Adequate renal function (within 4 weeks prior to registration): the calculated creatinine clearance should be ≥50 ml/min
* Accessible for treatment and follow-up
* Written informed consent

Inclusion criteria randomization specific:

In order to be eligible to be randomized in this study, a subject must meet all of the following criteria:

* Registration in the NEOLBC trial before 2 weeks biopsy
* Use of letrozole
* Outcome central Ki67 determination in two weeks biopsy available.

Exclusion Criteria:

* Evidence of distant metastases (M1)
* Previous invasive breast cancer
* Prior chemotherapy, radiation therapy or hormonal therapy with the exception of patients who received letrozole ≤ 14 days (+ max. 4 days) prior to registration and who are still on letrozole.
* Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
* Peripheral neuropathy \> grade 2, whatever the cause
* Serious other diseases as infections (hepatitis B, C and HIV), recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias or on screening, any of the following cardiac parameters: bradycardia (heart rate \<50 at rest) or QTcF ≥450 msec.
* Known hypersensitivity reaction to any of the components of the treatment (peanuts, soy)
* Currently receiving warfarin or other coumarin derived anti-coagulant, for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH), or fondaparinux is allowed.
* Currently receiving any of the following substances and cannot be discontinued 7 days prior to randomisation:

  * Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelo's, star-fruit, pomegranate and Seville oranges.
  * That have a known risk to prolong the QT interval or induce Torsades de Pointes.
  * That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5.
  * Herbal preparations/medications, dietary supplements.
* Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent.