Erken Evre Üçlü Negatif Meme Kanserinde Adjuvan Kapesitabin Sırasında Seri Dolaşan Tümör DNA'sı (ctDNA) İzlemi

Sade dilde özet

Bu çalışma, erken evre üçlü negatif meme kanseri (triple-negative breast cancer) olan hastalarda, adjuvan Capecitabine tedavisi sırasında kanda dolaşan tümör DNA'sının (ctDNA) seri ölçümlerle izlenmesini değerlendiriyor. Çalışmaya, neoadjuvan kemoterapi sonrası kalıntı hastalığı bulunan, metastaz belirtisi olmayan 18 yaş ve üzeri hastalar alınmaktadır. Çalışma Faz 2 aşamasında yürütülmüş ve halen katılımcı almaktadır.

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

Deney bilgileri

Faz

Faz 2 (Phase 2)

Durum

Katılımcı alıyor

Sponsor

Stanford University

Müdahale

Capecitabine

Başlangıç

03.02.2021

Tahmini bitiş

01.07.2031

Ülkeler

United States

İlgili genler

Merkezler

• Stanford, United States

Uygunluk kriterleri

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

Inclusion Criteria:

1. Anatomic stage I - III triple-negative breast cancer at diagnosis
2. Estrogen receptors (ER) and Progesterone receptors (PR) status \<10%
3. Residual disease following at least 4 cycles of neoadjuvant chemotherapy. Patients who received other investigational immunotherapy or targeted therapy during the neoadjuvant phase of treatment are eligible.
4. ≥ 18 years of age
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
6. All clinically significant toxic effects of prior cancer therapy resolved to Grade ≤ 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI CTCAE, v 5.0), except alopecia and G2 neuropathy.
7. No evidence of metastatic disease.
8. A minimum 4-week wash out from previous chemotherapy treatment is required.
9. Adequate hematologic function: Absolute neutrophil count (ANC) ≥ 1,500 cells/μL (≥ 1,500/mm3); Platelets ≥ 100,000 cells/μL (≥ 100,000/mm3)
10. Adequate hepatic function: Bilirubin ≤ 1.5 times the specific institutional upper limit of normal (ULN). Exception: If Gilbert's syndrome; then ≤ 5 times ULN. Aspartate transaminase (AST) and alanine transaminase (ALT) each ≤ 2.5 x ULN
11. Adequate renal function: Serum creatinine ≤ 1.5 x ULN; or calculated creatinine clearance \> 50 mL/min using the Cockcroft Gault formula.
12. Planned for 6 months or 8 cycles of adjuvant capecitabine.
13. Women of childbearing potential (WOCBP) must have a negative pregnancy test.
14. WOCBP must agree to use effective contraception during the study and for 3 months after the last dose.
15. Male participants and their female partners of child bearing potential must be willing to use an appropriate method of contraception during the study and for 3 months after the last dose.
16. Capable of giving signed informed consent, which includes compliance with requirements and restrictions listed in the informed consent form (ICF) and in the protocol

Exclusion Criteria:

1. Metastatic breast cancer
2. Has not had definitive surgical resection
3. Pregnant or breastfeeding
4. Has not completed definitive adjuvant radiation if planned
5. Known human immunodeficiency virus (HIV) positivity or active hepatitis B or C.
6. Investigational agents within 4 weeks of study initiation
7. Inability to swallow oral medications