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

Phase 2

Terminated

• Conditions: Breast Cancer; Metastatic Breast Cancer; Recurrent Breast Cancer

• Registration Number: NCT02624700
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-12-03
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-08
• Study Start: 2016-01-28
• Primary Completion: 2019-07-10
• Study Completion: 2019-07-10
• Status Verified: 2020-06
• Results First Submitted: 2020-06-05
• Results First Submitted QC: 2020-06-30
• Last Update Submitted: 2020-06-30
• Results First Posted: 2020-07-14
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
The Percentage of Patients With Objective Response Either Partial Response (PR) or Complete Response(CR).	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). Overall Response = CR+PR, based on Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1).

Secondary Outcome Measures

Name	Time	Method
The Duration of Progression-free Survival (PFS).	2 years 3 months	Progression-free survival (PFS) defined as the time (in days) from initiation of study treatment until documented disease progression or death, whichever occurs first.
The 2-year Survival Rate After Initial Study Treatment.	2 years 3 months	The proportion of patients who are alive at 2 years following initiation of study treatment.
Number of Participants at Risk and Affected by Adverse Events (AEs)	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).

Trial Locations

Locations (1)

Virginia Commonwealth University/Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States