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Terminated • Phasen II • Stufe III, IV • ER negativ • PR negativ • HER2 negativ • Medical Oncology • Post-Menopausal • Interventionell

Folgendes wird aus ClinicalTrials.gov importiert:

2nd Line Treatment With Pemetrexed and Sorafenib for Recurrent or Metastatic Triple Negative Breast Cancer

This phase 2 clinical trial will evaluate the efficacy of the combination of pemetrexed and sorafenib in patients with recurrent or metastatic Triple Negative Breast Cancer (TNBC). Candidate pharmacodynamic and predictive biomarkers will also be evaluated.

This study is a single-arm, open-label, phase 2 study of a regimen of dose-dense pemetrexed and sorafenib to determine the objective response rate in patients with recurrent or metastatic TNBC. Eligible patients will be those who have had disease progression during or after treatment for recurrent or metastatic disease with one previous cytotoxic chemotherapy regimen. Additionally, patients with disease progression or recurrence during or within 6 months of completion of adjuvant or neoadjuvant therapy are also eligible. Correlative studies will be conducted using blood samples and archived tumor samples. Simon's two-stage design will be utilized in this study. In the first stage, if there are ≤ 3 patients of the first 18 efficacy-evaluable patients who have a partial or complete response, then the trial will end for futility. If ≥ 4 patients have a partial or complete response, patient accrual will continue in the second stage to add 10 more efficacy-evaluable patients. The total sample size for the Simon's two-stage design is 35 patients. Based on enrollment of 2-3 patients per month, the expected enrollment period will be about 12-18 months. Patients were enrolled in 2 sequential groups, referred to as "arms" for the purposes of reporting results by group. The initial group of patients were enrolled in what is referred to here as Arm A. After a study amendment patients were enrolled in what is referred to here as Arm B.

Breast Cancer

Studiendesign
Studientyp:

Interventional

Geschätzte Einschreibung:

13 Teilnehmer

Aktueller Studienbeginn:

28. Januar 2016

Zulassungskriterien
Alter für die Studie berechtigt:

18 - 999

Geschlechter für die Studie berechtigt:

both


Arms and Intervention
  • Experimental Arm A: Pemetrexed

  • Experimental Arm A: Sorafenib

  • Experimental Arm B: Pemetrexed

  • Experimental Arm B: Sorafenib

Trial Information at Site
Last Updated:
Studieninformationen
ClinicalTrial.gov ID:

Terminated

Estimated Enrollment:

13

Last Updated:

12/06/2021


Hauptermittler

Andrew S Poklepovic, MD


Studiensponsor

Virginia Commonwealth University

Study Location (1)
Outcomes4Me

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