Imetelstat in Combination With Paclitaxel (With or Without Bevacizumab) in Patients With Locally Recurrent or Metastatic Breast Cancer

Phase 2

Completed

Brief Summary: The purpose of this study is to evaluate the efficacy and safety of treatment with imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone for patients with locally recurrent or metastatic breast cancer who have not received chemotherapy or have received one non-taxane based chemotherapy for metastatic breast cancer.

Detailed Description: Patients will be randomized in a 1:1 ratio to imetelstat + paclitaxel (with or without bevacizumab) versus paclitaxel (with or without bevacizumab) alone.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Women who are pregnant or breast feeding
Locally recurrent disease amenable to resection with curative intent
HER-2-positive breast cancer
Active central nervous system (CNS) metastatic disease including those patients receiving radiotherapy and/or steroid treatment (within the last 3 months)
Prior adjuvant or neoadjuvant taxane chemotherapy within 12 months prior of first relapse
Investigational therapy within 4 weeks of first study drug administration
Prior radiation, cytotoxic, or hormonal therapy within 2 weeks of first study drug administration
Therapeutic anti-coagulation or regular use of anti-platelet therapy within 2 weeks prior to first study drug administration (low dose anti-coagulant therapy to maintain patency of a vascular access device is allowed)
Grade ≥ 2 neuropathy
Uncontrolled clinically significant atrial or ventricular arrhythmias (unless pacemaker in place)
Severe conduction disturbance including clinically significant QTC prolongation > 450 ms (unless pacemaker in place)
Active or chronically recurrent bleeding (e.g., active peptic ulcer disease)
Clinically relevant active infection
Known positive serology for human immunodeficiency virus (HIV)

Arm && Interventions

Group	Intervention	Description
Imetelstat + Paclitaxel (with or without bevacizumab)	Imetelstat sodium	-
Imetelstat + Paclitaxel (with or without bevacizumab)	Bevacizumab	-
Paclitaxel (with or without bevacizumab) alone	Bevacizumab	-
Paclitaxel (with or without bevacizumab) alone	Paclitaxel	-
Imetelstat + Paclitaxel (with or without bevacizumab)	Paclitaxel	-

Primary Outcome Measures

Name	Time	Method
Progression-free survival	Occurring post randomization through end of study period (9 mos. after the last participant is randomized)	Defined as the time from randomization to documented disease progression, as determined by the investigator's assessment according to RECIST, or death from any cause, whichever occurs first.

Secondary Outcome Measures

Name	Time	Method
Clinical benefit rate	Occurring post randomization through end of study period (9 mos. after the last participant is randomized)	Clinical response rate includes patients with objective response and stable disease lasting at least 6 months.
Objective response	Occurring post randomization through end of study period (9 mos. after the last participant is randomized)	Objective response as determined by the investigator according to RECIST for patients with measurable disease at baseline.

Locations (54): Clearview Cancer Center
🇺🇸
Huntsville, Alabama, United States
Alta Bates Summit Medical Center
🇺🇸
Berkeley, California, United States
Southbay Oncology Hematology Partners
🇺🇸
Campbell, California, United States
Cancer Care Associates
🇺🇸
Tulsa, Oklahoma, United States
Memorial Miller Hospital
🇺🇸
Long Beach, California, United States
St. Joseph Hospital
🇺🇸
Orange, California, United States
Desert Regional Comprehensive Cancer Center
🇺🇸
Palm Springs, California, United States
UC San Diego
🇺🇸
San Diego, California, United States
Redwood Regional Medical Group
🇺🇸
Santa Rosa, California, United States
Univ. Colorado at Denver
🇺🇸
Aurora, Colorado, United States
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Clearview Cancer Center
🇺🇸Huntsville, Alabama, United States