Letrozole and Imatinib Mesylate in Treating Postmenopausal Participants With Estrogen or Progesterone Positive Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Anatomic Stage IV Breast Cancer AJCC v8, Estrogen Receptor Positive, KIT Positive, PDGFR Positive, Postmenopausal, Progesterone Receptor Positive, Prognostic Stage IV Breast Cancer AJCC v8

In brief

This phase II trial studies the side effects and how well letrozole and imatinib mesylate work in treating postmenopausal participants with estrogen or progesterone positive breast cancer that has spread to other places in the body. Letrozole is an antihormonal drug used in the standard treatment of hormonal sensitive breast cancer. Imatinib mesylate is a drug that binds to certain proteins on the tumor cells and prevents them from further growth. Imatinib mesylate is thought to prevent the potential resistance to letrozole, which may make the letrozole more effective. Giving letrozole and imatinib mesylate may work better in treating participants with breast cancer.

Key facts

Study ID: NCT00338728
Run by: M.D. Anderson Cancer Center
People needed: 59
Starts: 2003-10-03
Expected to finish: 2018-11-27
Last updated by the study team: 2020-01-27

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

Postmenopausal women able to comply with the protocol requirements with metastatic breast cancer, whose tumors are estrogen (ER) and/or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with greater than 10% positive malignant epithelial cells
Patients must have documented expression of either PDGFR or CD117 (c-kit) by immunohistochemistry
Patients may have received tamoxifen in the adjuvant/neoadjuvant or setting. Patients may have previously received chemotherapy in the adjuvant/ neoadjuvant setting, though this is not required. Prior chemotherapy for metastatic breast cancer is allowed. Concomitant bisphosphonates are allowed for patients with bone metastases and who have another site of measurable disease
Post menopausal status defined by one of the following: no spontaneous menses for at least 1 year, in women greater than or equal to 55 years spontaneous menses within the past 1 year in women greater than or equal to 55 years with postmenopausal gonadotrophin levels (luteinizing hormone [LH] and follicle stimulating hormone [FSH] levels greater than 40 IU/L ) or postmenopausal estradiol levels (less than 5 mg/dl) or according to the definition of "postmenopausal range" for the laboratory involved bilateral oophorectomy
Performance status, Eastern Cooperative Oncology Group (ECOG) greater than or equal to 2
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 greater than or equal to 10 mm with conventional techniques. Bone disease only will not be accepted as measurable disease. Pleural or peritoneal effusions will not be accepted as measurable disease
Absolute neutrophil count (ANC) = 1.5 x 10 to the 9th power/L
Platelets greater than or equal to 100.0 x 10 to the 9th power/L
Hemoglobin greater than 10.0 g/dL
Creatinine less than 1.5 mg/dl
Total (T.) bilirubin less than 1.5 x normal
Aspartate aminotransferase (AST) less than 2.5 x normal
A life expectancy of at least 6 months
Localized radiotherapy, which does not influence the signal of evaluable lesion, is allowed prior to the initiation of imatinib mesylate. Patients must have recovered from the myelosuppressive effects of previous radiotherapy (at least 2-4 weeks)
Ability to understand and the willingness to sign a written informed consent

You may not qualify if…

Prior treatment with Femara or Gleevec
Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, Cushing's syndrome, Addison's disease (treated or untreated)
Patients with unstable angina, or uncontrolled cardiac disease (e.g. class III or IV New York Heart Association's functional classification)
Other concurrent malignant disease with the exception of cone-biopsied in situ carcinoma of the cervix uteri, or adequately treated basal or squamous cell carcinoma of the skin, or other curable cancers e.g. Hodgkin's disease or non-Hodgkin lymphoma (NHL), provided 5 years have elapsed from completion of therapy, and there has been no recurrence
Concomitant treatment with steroids, e.g. glucocorticoids for indications other than cancer, except aerosol for obstructive airways diseases and steroid injection to the joints for treatment of inflammation
Other investigational drugs within the past 3 weeks and the concomitant use of investigational drugs
History of non-compliance to medical regimens and patients who are considered potentially unreliable
Patients with known brain metastasis
Patients with known chronic liver disease (i.e., chronic active hepatitis, and cirrhosis)
Patients with known diagnosis of human immunodeficiency virus (HIV) infection
Patients who received chemotherapy within 4 weeks (6 weeks for nitrosourea or mitomycin-C) prior to study entry, unless the disease is rapidly progressing
Patients who previously received radiotherapy to greater than or equal to 25% of the bone marrow
Patients who had a major surgery within 2 weeks prior to study entry

Where it is running

M D Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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