NordicTrip: Üçlü Negatif Meme Kanserinde Ameliyat Öncesi Kemoterapinin Translasyonel Çalışması

Sade dilde özet

Bu çalışma, üçlü negatif meme kanseri (triple negative breast cancer) olan hastalarda ameliyat öncesi (neoadjuvan) kemoterapiyi (epirubicin, cyclophosphamide, paclitaxel, carboplatin, pembrolizumab ve capecitabine gibi ilaçlar) inceleyen translasyonel bir çalışmadır. Çalışmaya, tek taraflı, östrojen reseptörü negatif ve HER2 normal meme kanseri olan, neoadjuvan kemoterapi ve ardından ameliyat planlanan, 18-75 yaş arası hastalar katılabilmektedir. Faz 3 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 3 (Phase 3)

Durum

Devam ediyor, katılım kapalı

Sponsor

Lund University Hospital

Müdahale

epirubicin, cyclophosphamide, paclitaxel, carboplatin, pembrolizumab, epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin, pembrolizumab

Başlangıç

20.12.2019

Tahmini bitiş

01.09.2035

Ülkeler

Denmark, Sweden

İlgili genler

Merkezler

• Vejle, Denmark
• Aalborg, Denmark
• Copenhagen, Denmark
• Esbjerg, Denmark
• Hillerød, Denmark
• Næstved, Denmark
• Sønderborg, Denmark
• Vejle, Denmark
• Kristianstad, Sweden
• Borås, Sweden
• Gävle, Sweden
• Gothenburg, Sweden
• Halmstad, Sweden
• Jönköping, Sweden
• Karlstad, Sweden
• Malmö, Sweden
• Örebro, Sweden
• Stockholm, Sweden
• Stockholm, Sweden
• Sundsvall, Sweden
• Umeå, Sweden
• Uppsala, Sweden
• Vaxjo, Sweden
• Västerås, Sweden

Uygunluk kriterleri

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

Inclusion Criteria:

1. Signed written informed consent approved by the Ethical Review Board (IRB).
2. Age ≥ 18 to \< 76 years.
3. Histologically confirmed unilateral adenocarcinoma of the breast where neoadjuvant chemotherapy followed by definitive surgery is planned.
4. Node positive disease (N1-3) or if clinically N0 Tumor size \>20 mm. When deciding T-stage the following hierarchy applies,

   1. MRI
   2. Ultrasound
   3. Mammography
   4. Clinical examination
5. ER negative tumor defined by at least one the following:

   1. ER \< 1% cells positive by immunohistochemistry (IHC) or ER ≤ 10% cells positive by IHC and basal-like subtype using gene expression analysis
   2. ER \< 10% cells positive by IHC and PgR \< 10% cells positive by IHC
6. HER2-normal tumor defined according to applicable national guidelines
7. Consent for germline mutation screening for BRCA1, BRCA2 and other inherited breast cancer associated genes.
8. WHO performance status 0 or 1.
9. Negative pregnancy test in women of childbearing potential (premenopausal or \<12 months of amenorrhea post-menopause and who have not undergone surgical sterilization).
10. Willingness of female patients of childbearing potential, male patients, and their sexual partners to use an effective means of contraception during the treatment period and at least 6 months thereafter.
11. Willingness by the patient to undergo treatment and study related procedures according to the protocol.

Exclusion Criteria:

1. Clinical or radiological signs of metastatic disease.
2. History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or non-melanoma skin cancer.
3. Previous chemotherapy for cancer or other malignant disease.
4. Charlson comorbidity index, excluding score for malignancy: (CCI) \> 2, Comment: In patients 70-75 a CCI = 3 is allowed, see appendix B.
5. Inadequate organ function, suggested by the following laboratory results:

   a Absolute neutrophil count \< 1,5 x 109/L

   b Platelet count \< 100 x 109/L

   c Hemoglobin \< 90 g/L

   d Total bilirubin greater than the upper limit of normal (ULN) unless the patient has documented Gilbert´s syndrome

   e ASAT (SGOT) and/or ALAT (SGPT) \> 2,5 x ULN

   f ASAT (SGOT) and/or ALAT (SGPT) \> 1,5 x ULN with concurrent serum alkaline phosphatase (ALP) \> 2,5 x ULN

   g Serum creatinine clearance \< 50 ml/min
6. Concurrent peripheral neuropathy of grade 3 or greater (NCI-CTCAE, Version 5.0).
7. Patient who is actively breast feeding.
8. Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol.
9. Patients with known deficiency of the DPD-enzyme who completely lack DPD.