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Phase II Study of Letrozole (Femara) Plus Imatinib Mesylate (Gleevec) for Postmenopausal Patients With ER and/or PR Positive Metastatic Breast Cancer

Phase 2
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

Phase II Study of Letrozole (Femara) Plus Imatinib Mesylate (Gleevec) for Postmenopausal Patients With ER and/or PR Positive Metastatic Breast Cancer

Letrozole is an antihormonal drug used in the standard treatment of advanced hormonal
sensitive breast cancer. Imatinib mesylate is a drug (not chemotherapy) 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.

Before the treatment starts, you will have blood tests (2-4 teaspoons), CT scans of your
chest and abdomen, and a bone scan. Blood tests (2-4 teaspoons) will be repeated every week
for 4 weeks and then every month for the length of the study. The blood tests are done to
evaluate how the drug affects breast cancer related markers in the blood. These blood tests
will be done at screening, and then at Months 2 and 4. The CT scans will be repeated every 2
months as is standard for your care.

You will take letrozole once a day by mouth and imatinib mesylate twice a day by mouth until
intolerable side effects occur or until your tumor grows further. You will stop the
treatment if your tumor grows or intolerable side effects occur.

This is an investigational study. Letrozole is FDA approved for the treatment of advanced
breast cancer and is commercially available. Imatinib mesylate is approved for chronic
myelogenous leukemia and is being investigated for use in the treatment of breast cancer. A
total of 45 patients will take part in this study. All will be enrolled at M. D. Anderson.

Inclusion Criteria:

1. 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.

2. Patients must have documented expression of either PDGFR or CD117 (c-kit) by

3. 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.

4. 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 (LH and FSH levels greater than 40 IU/L ) or postmenopausal
estradiol levels ( less than 5mg/dl) or according to the definition of
"postmenopausal range" for the laboratory involved bilateral oophorectomy.

5. Performance status, ECOG greater than or equal to 2.

6. 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.

7. Adequate bone marrow function (ANC = 1.5 x 10 to the 9th power/L and platelets
greater than or equal to 100.0 x10 to the 9th power/L, and hemoglobin greater than
10.0 g/dL).

8. Adequate renal function (creatinine less than 1.5 mg/dl) and hepatic function (T.
Bilirubin less than 1.5 x normal, AST less than 2.5 x normal)

9. A life expectancy of at least 6 months.

10. 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).

11. Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

1. Prior treatment with Femara or Gleevec.

2. Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or
hyperthyroidism, Cushing's Syndrome, Addison's disease (treated or untreated).

3. Patients with unstable angina, or uncontrolled cardiac disease (e.g. Class III or IV
New York Heart Association's Functional Classification).

4. 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 NHL, provided 5 years
have elapsed from completion of therapy, and there has been no recurrence.

5. 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.

6. Other investigational drugs within the past 3 weeks and the concomitant use of
investigational drugs.

7. History of non-compliance to medical regimens and patients who are considered
potentially unreliable.

8. Patients with known brain metastasis.

9. Patients with known chronic liver disease (i.e., chronic active hepatitis, and

10. Patients with known diagnosis of human immunodeficiency virus (HIV) infection.

11. Patients who received chemotherapy within 4 weeks (6 weeks for nitrosourea or
mitomycin-C) prior to study entry, unless the disease is rapidly progressing.

12. Patients who previously received radiotherapy to greater than or equal to 25% of the
bone marrow.

13. Patients who had a major surgery within 2 weeks prior to study entry.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall Response

Outcome Time Frame:

Every week for first four weeks then every month, or until disease progression

Safety Issue:


Principal Investigator

Banu Arun, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Letrozole
  • Imatinib Mesylate
  • Gleevec
  • Femara
  • Breast Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030