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TERMINATEDPHASE2

Tanespimycin in Treating Women With Refractory Locally Advanced or Metastatic Breast Cancer

A Phase II Clinical Trial of 17-Allyamino-17-Demethoxygeldanamycin (17-AAG) in Chemotherapy Refractory Metastatic Breast Cancer

NCT00096109•National Cancer Institute (NCI)

View on ClinicalTrials.gov

Summary

This phase II trial is studying how well tanespimycin works in treating women with refractory locally advanced or metastatic breast cancer. Drugs used in chemotherapy, such as tanespimycin, work in different ways to stop tumor cells from dividing so they stop growing or die

Detailed Description

PRIMARY OBJECTIVES: I. To determine the response rate of 17-Allylamino-17-Demethoxygeldanamycin (17-AAG) (tanespimycin) in patients with refractory/resistant metastatic breast cancer. II. To determine the progression free survival (PFS) of patients with refractory/resistant metastatic breast cancer when treated with 17-AAG. III. To correlate patients' her2/neu status with response to 17-AAG treatment. OUTLINE: This is a multicenter study. Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed at day 30, every 10-12 weeks until disease progression, and then every 3 months thereafter.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Primary adenocarcinoma of the breast confirmed by histology or cytology
•Locally advanced or metastatic disease not amenable to surgery or radiation therapy with curative intent
•At least 1 measurable (target) lesion (i.e. any malignant tumor mass that can be accurately measured in at least 1 dimension of \>= 2 cm with conventional radiographic techniques or \>= 1 cm with magnetic resonance imaging \[MRI\] or spiral computerized tomography \[CT\] scans), not previously irradiated
•Progressive disease following hormonal therapy in appropriate patients (ER-positive and/or indolent disease)
•Progressive disease following treatment with both an anthracycline and a taxane (as adjuvant therapy or for metastatic disease) or contraindication to such treatment
•All previous cytotoxic chemotherapy must have been discontinued at least 4 weeks before study entry and all acute toxicity of prior therapy (excluding alopecia and neurotoxicity) must be resolved to NCI CTC (Version 3.0) grade =\< 1; patients must have discontinued treatment with nitrosoureas or mitomycin C at least 6 weeks prior to study entry
•All previous hormonal therapy must have been discontinued for at least 2 weeks before study entry
•Life expectancy of \>= 3 months
•ECOG performance status (PS) of 0-2
•Absolute neutrophil count (ANC) \>= 1500/mm\^3
+27 more criteria

Exclusion Criteria

•Current treatment with any other anti-neoplastic agent, including trastuzumab; patients may continue to receive zoledronic acid for bone metastases or hypercalcemia
•Radiation therapy within 2 weeks of enrollment or surgery within 4 weeks
•Known brain or leptomeningeal metastatic disease requiring active therapy; (Patients with asymptomatic previously treated metastases to these areas are eligible)

Locations (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Key Dates

Start Date

September 1, 2005

Primary Completion Date

May 1, 2012

Completion Date

May 1, 2012

Last Updated

January 16, 2017

Enrollment

ACTUAL participants

Conditions

Recurrent Breast CancerStage IIIB Breast CancerStage IIIC Breast CancerStage IV Breast Cancer

Interventions

tanespimycin

DRUG

laboratory biomarker analysis

OTHER

Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer

NCT06324240

Anatomic Stage I Breast Cancer AJCC v8Anatomic Stage IA Breast Cancer AJCC v8+25 more

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RECRUITINGPHASE2

A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer

NCT06369285

Hormone Receptor Positive HER-2 Negative Breast CancerMetastatic Breast Cancer+1 more

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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: January 16, 2017Data 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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Tanespimycin in Treating Women With Refractory Locally Advanced or Metastatic Breast Cancer

Inclusion Criteria

Exclusion Criteria

Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer

A Study of Alisertib in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer

Piloting Y-AMBIENT: A Quality of Life Intervention for Young African American Breast Cancer Survivors

Pembrolizumab in Treating Participants With Metastatic, Recurrent or Locally Advanced Cancer and Genomic Instability

Intensity Modulated Radiation Therapy or 3-Dimensional Conformal Radiation Therapy in Treating Patients With Lymph-Node Positive Breast Cancer

Taxane and Taxane-Induced Peripheral Neuropathy in African American Patients With Stage I-III Breast Cancer