2nd Line Treatment With Pemetrexed and Sorafenib for Recurrent or Metastatic Triple Negative Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02624700|
Recruitment Status : Recruiting
First Posted : December 8, 2015
Last Update Posted : September 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Metastatic Breast Cancer Recurrent Breast Cancer||Drug: Pemetrexed Drug: Sorafenib||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 2 Study of Pemetrexed and Sorafenib for Treatment of Recurrent or Metastatic Triple Negative Breast Cancer|
|Study Start Date :||January 28, 2016|
|Estimated Primary Completion Date :||April 1, 2024|
|Estimated Study Completion Date :||April 1, 2025|
Experimental: A: Pemetrexed + Sorafenib
All study participants will get the same study treatment. Each participant will be given pemetrexed intravenously which means by vein (IV) once every 21days.They will take sorafenib pills by mouth two times each day for 5 days starting on the pemetrexed treatment day. The treatment is Pemetrexed 375 mg/m2 IV Day 1 + Sorafenib 200mg PO twice each day on Days 1-5 of each 21-day cycle
Treatment schedule is administered on day 1 of each 21-day cycle by Intravenous infusion over 10 minutes with a dose of 375 mg/m2. If necessary, the duration of the pemetrexed infusion may be extended to a maximum of 20 minutes.
Other Name: Alimta
Treatment schedule is administered twice daily by mouth on an empty stomach on days 1-5 of each 21-day cycle with a dose of 200 mg.
Other Name: Nexavar
- The percentage of objective response either Partial Response (PR) or Complete Response(CR). [ Time Frame: 2 years 3 months ]The primary endpoint is the percentage of patients with HER2-negative metastatic breast cancer achieving an objective response (either PR or CR). The proportion of patients who have a response will be calculated along with its 95% confidence interval by the biased-reduced estimation method by Chang et al (36), recommended by Porcher and Desseaux (37).
- The percentage of progression-free survival (PFS). [ Time Frame: 2 years 3 months ]Progression-free survival (PFS) defined as the time from initiation of study treatment until documented disease progression or death, whichever occurs first. The Kaplan-Meier method will be used to describe the time to death or disease progression; the median time to death or progression will be estimated, along with 95% confidence intervals. A Cox regression model may be used to model the time to death or progression, adjusting for any effects of potential covariates (such as tumor size, tumor stage, biomarker, and age).
- To determine the 2-year survival rate after initial study treatment. [ Time Frame: 2 years 3 months ]The proportion of patients who are alive at 2 years following initiation of study treatment.
- The amount of reported Adverse events (AEs). [ Time Frame: 2 years 3 months ]To further characterize the safety and side effect profile of the combination. All participants' AEs will be listed and summary descriptive statistics will be calculated.The Adverse events (AEs) are reported using criteria in the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 (CTCAE v4.0).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02624700
|Contact: Alison Ryan, NPfirstname.lastname@example.org|
|Contact: Andrew S. Poklepovic, MDemail@example.com|
|United States, Virginia|
|Virginia Commonwealth University/Massey Cancer Center||Recruiting|
|Richmond, Virginia, United States, 23298|
|Contact: Alison Ryan, NP 804-628-1936 firstname.lastname@example.org|
|Contact: Andrew S Poklepovic, MD 804-628-2321 email@example.com|
|Principal Investigator: Andrew S Poklepovic, MD|
|Principal Investigator:||Andrew S Poklepovic, MD||Massey Cancer Center|