An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to determine if ganetespib (STA-9090) is effective in the treatment of patients with HER2+ or triple negative breast cancer who have not received prior systemic treatment in the metastatic setting.

Official Title
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An Open-Label Multicenter Phase 2 Window of Opportunity Study Evaluating Ganetespib in Women With Breast Cancer

Conditions
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Breast Cancer, HER-2 Positive Breast Cancer, Triple Negative Breast Cancer, ER/Progressive Response (PR) + Refractory to Prior Hormonal Treatment

Intervention / Treatment
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* Drug: ganetespib


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologically confirmed diagnosis of invasive breast cancer. Stage IV disease. Documented HER2 and hormonal receptor status per protocol, ER/PR+ patients must be refractory to at least one prior hormonal treatment. ECOG Performance status 0-1. Measurable disease per RECIST (1.1). Adequate hematological function per protocol. Adequate hepatic function per protocol. Adequate renal function per protocol. Negative serum pregnancy test at study entry for patients of childbearing potential. Ability to understand and sign written consent and to comply with the study protocol. Exclusion Criteria: Presence of active or untreated CNS metastases as determined by MRI/CT scan performed during screening. Active malignancies other than MBC within the last 5 years except adequately treated in situ carcinoma of the cervix uteri or basal or squamous cell carcinoma of the skin. Bone as the only site of metastatic disease from breast cancer. Prior radiotherapy to the only area of measurable disease. NOTE: Radiotherapy to a limited area other than the sole site of measurable disease is allowed, if received prior to initiation of ganetespib treatment. Patients must have completed treatment and recovered from all acute treatment-related toxicities prior to administration of first dose of ganetespib. Pregnancy or lactation. Known serious cardiac illness. Uncontrolled intercurrent illness per protocol. Other severe acute or chronic medical condition or abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, or that in the judgment of the investigator would make the patient inappropriate for entry into the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HER2+ breast cancer<br> | Drug: ganetespib<br>* Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.<br>|
| Experimental: Triple negative breast cancer<br>Closed to enrollment | Drug: ganetespib<br>* Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.<br>|
| Experimental: ER/PR+ Refractory to Prior Hormonal Treatment<br> | Drug: ganetespib<br>* Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate | Objective response rate is based on RECIST criteria | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response and progression free survival | Progressive disease based on RECIST criteria. CT scans at week 6, week 12 and every 6 weeks thereafter for the duration of the study. | Every six weeks until progression | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hsp90 inhibitor, ganetespib, STA 9090