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COMPLETEDPHASE2

Open-label Study of STA-9090 for Patients With Metastatic Breast Cancer

A Phase 2 Open-label Study of STA-9090 for Patients With Metastatic Breast Cancer

NCT01273896•Memorial Sloan Kettering Cancer Center

Summary

The purpose of this study is to find out what effects, good and/or bad, STA-9090 has on the patient and their breast cancer. STA-9090 is an experimental drug that works by breaking down cancer proteins. When the cancer proteins are destroyed, the cancer cells die. STA-9090 is an experimental drug that is not yet approved for the treatment of cancer by the United States (FDA) Food and Drug Administration . STA-9090 has been tested in cancer patients in other trials and a safe dose for this drug has been found. We are now interested to see how active this drug is against breast cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male and Female patients must be at least 18 years of age
•Pathologically confirmed diagnosis of breast cancer
•Metastatic or advanced stage breast cancer
•Prior treatment with at least one and no more than three lines of biologic and/or chemotherapy for metastatic breast cancer (excluding hormonal therapy)
•Patients with HER2+ disease must have received prior treatment with Trastuzumab
•Patients with ER and/or PR+ disease must have received prior treatment with hormonal therapy
•Off cytotoxic chemotherapy or biologic therapy (excluding Hormonal therapy) ≥ 3 weeks
•Measurable disease by RECIST 1.1
•Central nervous system metastases are permitted if treated and radiographically and clinically stable for at least 4 weeks prior to first dose of STA-9090
•Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
+15 more criteria

Exclusion Criteria

•Surgery, radiotherapy, or lesion ablative procedure to the only area of measurable disease
•Major surgery within 4 weeks prior to first dose of STA-9090
•Poor peripheral venous access for study drug administration. Study drug administration via indwelling catheters allowed only if the catheter is made of silicone material.
•History of severe (grade 3 or 4) allergic or hypersensitivity reactions to excipients (e.g., Polyethylene glycol \[PEG\] 300 and Polysorbate 80)
•Baseline QTc \> 470 msec
•Ventricular ejection fraction (EF) \<50% at baseline
•Treatment with chronic immunosuppressants (e.g., cyclosporine following transplantation)
•Women who are pregnant or lactating
•Uncontrolled intercurrent illness including, but not limited to, human immunodeficiency virus (HIV)-positive subjects receiving combination antiretroviral therapy, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, ventricular arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
•Other medications, or severe acute/chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results in the judgment of the investigator
+6 more criteria

Locations (5)

Memorial Sloan-Kettering at Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan-Kettering Cancer Center at Commack

Commack, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan-Kettering Cancer Center at Mercy Medical Center

Rockville Centre, New York, United States

Memorial Sloan-Kettering Cancer Center at Phelps Memorial Hospital Center

Sleepy Hollow, New York, United States

Key Dates

Start Date

January 1, 2011

Primary Completion Date

September 1, 2013

Completion Date

September 1, 2013

Last Updated

November 20, 2015

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

STA-9090

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 20, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Open-label Study of STA-9090 for Patients With Metastatic Breast Cancer

Inclusion Criteria

Exclusion Criteria

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer