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Recurrent Breast CancerPhase 2NCT00096109

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

A Phase 2 study testing tanespimycin and laboratory biomarker analysis in people with Recurrent Breast Cancer and Stage IIIB Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
tanespimycin and laboratory biomarker analysis
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
Sep 2005to May 2012
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Platelets >= 100,000/mm^3
  • Hemoglobin >= 9.0 g/dL
  • Creatinine (Cr) =< upper limit of normal (ULN) or Cr Clearance > 60 mL/min/m^2
  • Total bilirubin =< 1.5X ULN
  • Alanine aminotransferase (ALT) =< 1.5X ULN or =< 3X ULN with liver metastases
  • Aspartate aminotransferase (AST) =< 5X ULN or =< 3X ULN with liver metastases
  • Negative serum pregnancy test within 7 days of enrollment for pre-menopausal women or women within 6 months of menopause
  • Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
  • Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed and understands all pertinent aspects and the investigational nature of the trial

Who cannot join

  • 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)
  • Any of the following conditions within 6 months of enrollment: myocardial infarction, severe/unstable angina, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, coronary/peripheral artery bypass grafting; patients who have experienced a pulmonary embolus, deep venous thrombosis or other clinically significant thromboembolic event within 6 months of enrollment are eligible if they are clinically stable on anticoagulation therapy
  • Current active infection, including known human immunodeficiency virus (HIV) positivity; for HIV patients on highly active antiretroviral therapy (HAART), the pharmacokinetics of the investigation agent may be seriously affected; when appropriate, 17-AAG will be studied in patients with HIV on HAART
  • Pregnancy or breastfeeding; because of the unknown effects on the developing fetus/newborn, patients who are pregnant or become pregnant should be excluded from protocol study; exclusion of breast feeding women would also be appropriate as it is not known whether 17-AAG may be excreted in breast milk and what effect this may have on a developing newborn; female patients must agree to use effective contraception during the study period, be surgically sterile, or be post-menopausal; in addition, male patients will be required to use effective contraception during the study period or be surgically sterile; the definition of effective contraception will be based on the judgment of the investigator
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  • Serious allergy to eggs (i.e. hypotension, dyspnea, anaphylaxis, edema)
  • Treatment with any agents that interact with cytochrome P450 3A should be avoided and used with caution, if necessary; when possible, patients should be switched to alternative medications; patients requiring anticoagulation should not be treated with Coumadin and should be switched to a low molecular weight heparin injection; patients receiving treatment with a low molecular weight heparin will require episodic monitoring with the anti-factor Xa heparin assay
  • Previous (within 5 years of enrollment) or current malignancies at other sites, except adequately treated basal cell or squamous cell skin cancers and carcinoma in situ of the cervix
  • Other severe acute or chronic medical or psychiatric conditions or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for study entry
  • The use of concomitant medications that prolong or may prolong QTc are excluded
  • Patients who have significant cardiac disease including heart failure that meets New York Heart Association (NYHA) class III and IV definitions, history of myocardial infarction within one year of study entry, uncontrolled dysrhythmias, or poorly controlled angina are excluded
  • Patients who have a history of serious ventricular arrhythmia (VT or VF, >= 3 beats in a row), QTc >= 450 msec for men and 470 msec for women, or LVEF =< 40% by MUGA are excluded
  • Patients with a prior history of cardiac or pulmonary toxicity after receiving anthracyclines such as doxorubicin, daunorubicin, mitoxantrone, bleomycin or BCNU
  • Patients with greater or equal to grade 2 pulmonary or cardiac symptoms prior to study entry
  • Patients with a history of prior radiation that potentially included the heart in the field (e.g., mantle)
  • Patients with active ischemic heart disease within 12 months
  • Patients with a history of uncontrolled dysrhythmias or requiring antiarrhythmic drugs
  • Patients with congenital long QT syndrome; and patients with left bundle branch block
  • Patients with symptomatic pulmonary disease requiring medication including the following: dyspnea, dyspnea on exertion, paroxysmal nocturnal dyspnea, oxygen requirement and significant pulmonary disease, including chronic obstructive/restrictive pulmonary disease
  • Patients that meet the Medicare criteria for home oxygen
  • Patients with a prior history of chest radiation

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48202

Other trials in United States

About this study

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

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

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
tanespimycin, laboratory biomarker analysis
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tanespimycinDrug

    Also called 17-AAG

    Given IV

  • laboratory biomarker analysisOther

    Correlative studies

Study groups in NCT00096109
Study groupRoleWhat they receive
Treatment (tanespimycin)ExperimentalPatients 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.
Receives: Drug: tanespimycin; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response Rate (Complete Response (CR) +Partial Response (PR)

    Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: Up to 7 years

  2. Progression Free Survival (PFS)

    PFS is defined as either progression or death, whichever occurs first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

    Measured: Up to 7 years

  3. Her2/Neu Status

    Response rates will be estimated separately for her2/neu positive and her2/neu negative individuals along with 95% confidence intervals.

    PLEASE NOTE: IT WAS PROPOSED TO ANALYZE OUTCOME BY HER2 STATUS, NO DATA WAS COLLECTED OR EVALUATED.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2004 (estimated)
  2. Study startSep 2005
  3. Primary completionMay 2012
  4. Study completionMay 2012

Why it stopped: Closed to accrual before all 12 planned patients were enrolled.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00096109
Sponsor's protocol ID
NCI-2012-03058
Other IDs
C-2803, U01CA062502, U01CA062487, CDR0000391198
Status last verified
Nov 2016
First submitted
9 Nov 2004
Last updated
16 Jan 2017

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing tanespimycin and laboratory biomarker analysis in people with Recurrent Breast Cancer and Stage IIIB Breast Cancer, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 16 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response Rate (Complete Response (CR) +Partial Response (PR) (time frame: Up to 7 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00096109.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2017.

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