Yüksek Riskli Meme Kanserinin Kişiselleştirilmiş Tedavisi - PETREMAC Araştırması

Sade dilde özet

Bu çalışma, yüksek riskli meme kanserinde (breast cancer), tümörün genetik ve biyolojik özelliklerine göre kişiselleştirilmiş ameliyat öncesi (neoadjuvan) tedavileri değerlendirmekte olup, kullanılan ilaçlar arasında tamoxifen, letrozol, palbociclib, docetaxel, trastuzumab ve olaparib bulunmaktadır. Çalışmaya, daha önce tedavi görmemiş, 4 cm'den büyük iltihabi olmayan meme kanseri olan yetişkin hastalar alınmıştır. Çalışma Faz 2 aşamasında olup, 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

Haukeland University Hospital

Müdahale

Neoadjuvant tamoxifen + goserelin (premenopausal women), Neoadjuvant letrozole (postmenopausal women), Neoadjuvant endocrine therapy + palbociclib (if lack of response to endocrine therapy alone), Neoadjuvant docetaxel + cyclophosphamide, Neoadjuvant docetaxel, Neoadjuvant docetaxel + trastuzumab + pertuzumab, Neoadjuvant docetaxel + cyclophosphamide + trastuzumab + pertuzumab, Neoadjuvant olaparib, Neoadjuvant cyclophosphamide (after 10 weeks of olaparib alone), Breast conserving surgery or mastectomy + SNB/axillary dissection, Postoperative radiotherapy breast/chest wall + regional lymph nodes, Adjuvant trastuzumab, Adjuvant letrozole (postmenopausal women), Adjuvant tamoxifen + goserelin (premenopausal women), Adjuvant palbociclib (if palbociclib given neoadjuvant), Adjuvant Epirubicin+ Cyclophosphamide

Başlangıç

15.04.2016

Tahmini bitiş

01.06.2030

Ülkeler

Norway

İlgili genler

Merkezler

• Lørenskog, Norway
• Bergen, Norway
• Haugesund, Norway
• Stavanger, Norway
• Førde, Norway
• Trondheim, Norway
• Tromsø, Norway

Uygunluk kriterleri

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

Inclusion Criteria:

* Previously untreated, histologically confirmed non-inflammatory breast cancer, \>4 cm in diameter and /or metastatic ipsilateral axillary deposits for which the smallest diameter of the largest node \>2 cm by CT or ultrasound scan.
* WHO performance status 0-1
* Known tumor ER, PGR, HER2 and TP53 status.
* Known tumor Ki67 percentage (if ER/PGR\>50% and TP53 wt status).
* Distant metastasis not suspected. Patients will undergo radiology exams during screening phase, after signing the informed consent.
* Age \>18 years
* Patients must have clinically and/or radiographically documented measurable breast cancer according to RECIST.
* Radiology studies (CT thorax/abdomen and bone scintigraphy/bone scan) must be performed within 28 days prior to registration.
* Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
* Before patient registration/randomization, written informed consent must be given according to national and local regulations.
* For arms B-H:

  * Neutrophils \> 1.5 x 109/L
  * Platelets \> 100 x 109/L
  * Bilirubin \< 2 x upper limit normal (ULN). For patients with Gilbert´s syndrome bilirubin \>2 x ULN is accepted if there is no evidence of biliary obstruction.
  * Serum creatinine \< 1.5 x ULN
  * ALT and Alk Phos (ALP) \<2.5 x ULN
  * INR \< 1.5

Exclusion Criteria:

* Unstable angina pectoris or heart failure
* Other co-morbidity that, based on the assessment of the treating physician, may preclude the use of chemotherapy at actual doses.
* Pregnant or lactating patients can not be included.
* Clinical evidence of serious coagulopathy. Prior arterial/venous thrombosis or embolism does not exclude patients from inclusion, unless patient is considered unfit by study oncologist.
* Patient not able to give an informed consent or comply with study regulations as deemed by study investigator.
* Active cystitis (to be treated upfront)
* Active bacterial infections
* Urinary obstruction