Trastuzumab and Ixabepilone in Treating Women With HER2-Positive Metastatic Breast Cancer

Stopped early · Phase 2

Conditions studied: HER2-positive Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

In brief

This phase II trial is studying how well giving trastuzumab together with ixabepilone works in treating women with HER2-positive metastatic breast cancer. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining trastuzumab with ixabepilone may kill more tumor cells.

Key facts

Study ID: NCT00079326
Run by: National Cancer Institute (NCI)
People needed: 39
Starts: 2004-01-01
Expected to finish: 2010-10-01
Last updated by the study team: 2014-06-02

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Patients must have histologically or cytologically confirmed invasive breast cancer, with stage IV disease
Tumors must be HER2 overexpressing; acceptable methods of measurement of HER2 expression include immunohistochemistry IHC) and fluorescence in situ hybridization (FISH); tumors tested by IHC must be 3+ positive for HER2 overexpression; tumors tested by FISH must be positive by the specific FISH assay for genetic amplification of HER2; tumors that are 3+ by IHC, but negative by FISH assay are ineligible; consideration should be given to performing a repeat biopsy, with reanalysis for HER2 overexpression, in patients who have received prior trastuzumab, as little data exist on the persistence of HER2 overexpression after prior treatment with trastuzumab; biopsy in this circumstance, however, is not required
Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 20 mm with conventional techniques or as >= 10 mm with spiral CT scan; the protocol will employ the RECIST criteria
Prior Therapy - Two cohorts of patients will be treated on this treatment regimen; the two cohorts are determined by prior therapy and are as follows:
Treatment Cohort 1:
Chemotherapy: metastatic breast cancer: Patients in treatment Cohort 1 may NOT have received prior chemotherapy or prior trastuzumab therapy for metastatic breast cancer; patients may have received prior hormonal therapy for metastatic breast cancer
Chemotherapy: early stage breast cancer: Patients in treatment Cohort 1 may have received prior chemotherapy and/or hormonal therapy for early stage breast cancer; patients must be at least 6 months from prior chemotherapy received in the adjuvant setting
Trastuzumab: Patients in treatment Cohort 1 may have received trastuzumab in the adjuvant setting, provided that trastuzumab therapy ended at least 12 months prior to study participation; patients may not have previously received trastuzumab in the metastatic setting
Radiation therapy: Patients in treatment Cohort 1 may have received prior radiation therapy in either the metastatic or early stage settings; radiation therapy must be completed at least 7 days prior to study participation
Hormonal therapy: Patients in treatment Cohort 1 may have received hormonal therapy (therapies) in the adjuvant or metastatic setting; patients must discontinue hormonal therapy 2 weeks prior to study participation; patients with overt disease progression on prior hormonal therapy are eligible without waiting two weeks after discontinuing hormonal therapy, but must discontinue hormonal treatments prior to study participation
Treatment Cohort 2:
Chemotherapy: metastatic breast cancer: Patients in treatment Cohort 2 may have received up to two prior chemotherapy regimens for metastatic breast cancer; prior trastuzumab or other biologic or immunologic therapies are not considered to be chemotherapeutic regimens unless they were administered in conjunction with a chemotherapeutic agent; patients may have received prior hormonal therapy for metastatic breast cancer
Chemotherapy: early stage breast cancer: Patients in treatment Cohort 2 may have received prior chemotherapy and/or hormonal therapy for early stage breast cancer; if adjuvant chemotherapy was completed less than 6 months prior to the diagnosis of metastatic disease, the adjuvant regimen will be considered one of the two possible metastatic regimens
Trastuzumab: Patients in treatment Cohort 2 must have received one prior trastuzumab-containing regimen either in the metastatic setting or in the adjuvant setting; if the trastuzumab was administered in the adjuvant setting, disease recurrence must have occurred within 12 months of completion of adjuvant therapy
Radiation therapy: Patients in treatment Cohort 2 may have received prior radiation therapy in either the metastatic or early stage settings; radiation therapy must be completed at least 7 days prior to study participation
Hormonal therapy: Patients in treatment Cohort 2 may have received hormonal therapy (therapies) in the adjuvant or metastatic setting; patients must discontinue hormonal therapy 2 weeks prior to study participation; patients with overt disease progression on prior hormonal therapy are eligible without waiting two weeks after discontinuing hormonal therapy, but must discontinue hormonal treatments prior to study participation
Life expectancy of greater than 6 months
ECOG performance status =< 2 (Karnofsky >= 60%)
Patients must have adequate organ and marrow function as defined below; laboratory tests should be completed within 14 days prior to registration; left ventricular ejection fraction (LVEF) may be determined by either echocardiography or nuclear scintigraphy (i.e. MUGA scan or RVG), and should be obtained within 28 days prior to registration
Absolute neutrophil count >= 1,500/mm\^3
Platelets >= 100,000/mm\^3
Total bilirubin =< 1.5 X institutional upper limit of normal
ALT(SGPT) =< 5 X institutional upper limit of normal
LVEF >= 50%
Concurrent Therapy: patients may not receive concurrent hormonal therapy, chemotherapy, or radiation treatments while on study; patients requiring radiation therapy during protocol-based treatment will be taken off study; if patients develop intraparenchymal brain metastases while on treatment, but do not have evidence of other systemic progression, they will be allowed to resume treatment with the combination once their radiation has been completed; they will be allowed to continue trastuzumab therapy during radiation, at the treating physician's discretion; nevertheless, the date of discovery of the CNS disease will still be considered the date of disease progression; patients may receive concurrent bisphosphonate therapy (e.g. pamidronate) while on study; patients may not receive other experimental treatments while on study

You may not qualify if…

Patients may not be receiving any other investigational antitumor agents
Patients with leptomeningeal carcinomatosis are excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events; patients with a history of brain metastases are eligible, providing that they have completed treatment for their brain metastases at least 1 week prior to enrollment, are asymptomatic from their brain metastases and are not taking steroids; screening for CNS disease is not required if patients do not have symptoms that might be related to CNS metastases; patients with such symptoms should be evaluated for the possibility of CNS disease prior to study participation
Patients with a history of grade 3 or 4 allergic reactions attributed to compounds of similar chemical or biologic composition to the agents used in the study are ineligible; patients with a history of severe Cremophor reactions should be excluded; patients who experienced grade 1 or 2 hypersensitivity reactions to prior trastuzumab or taxane therapies are eligible IF these reactions did not prevent previous administration of such agents; patients who were deemed inappropriate candidates for trastuzumab or taxane-based treatments based on their hypersensitivity reactions are not eligible
Received prior epothilone therapy
Grade 2 or greater neuropathy (neuromotor or neurosensory)
Received prior high dose chemotherapy with bone marrow transplant or peripheral blood stem cell support within 2 years of study entry
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant women are excluded from this study because BMS-247550 and trastuzumab are agents which may have the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these drugs, breastfeeding should be discontinued if the mother is treated on study
Because patients with immune deficiency are at increased risk of lethal infections when treated with marrow-suppressive therapy, HIV-positive patients receiving anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with agents administered during the study

Where it is running

Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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