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Phase II Trial of STI571 in Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

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Trial Information

Phase II Trial of STI571 in Metastatic Breast Cancer


I. To determine the efficacy of STI571 in metastatic breast cancer (MBC) that demonstrates
expression of CD117 (c-kit) and/ or PDGFR.


I. To determine the clinical activity of STI571 in MBC with expression of CD117 (ckit) and/
or PDGFR by evaluating progression-free survival (PFS).

II. To determine the toxicity profile and tolerability of STI571 in patients with MBC.

III. To define serum, tissue and imaging surrogate endpoints of activity of STI571 in MBC.


Patients receive oral imatinib mesylate twice daily. Treatment continues for at least 8
weeks in the absence of disease progression or unacceptable toxicity.

Inclusion Criteria:

- Histologically or cytologically confirmed metastatic breast cancer

- Documented expression of CD117 (c-kit) or platelet-derived growth factor receptor

- Adequate tumor tissue from either the primary tumor and/or metastatic disease
available for evaluation

- Must have received prior chemotherapy with an anthracycline (doxorubicin or
epirubicin) and/or taxane (paclitaxel or docetaxel) as adjuvant or for advanced

- At least 1 unidimensionally measurable lesion

- At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

- Bone disease may not be only source of measurable disease

- Pleural or peritoneal ascites are not considered measurable disease

- No known brain metastases

- Hormone receptor status:

- Not specified

- Female or male

- Not specified

- Performance status - ECOG 0-2

- Performance status - Karnofsky 60-100%

- More than 12 weeks

- Absolute neutrophil count at least 1,500/mm^3

- WBC at least 3,000/mm^3

- Platelet count at least 100,000/mm^3

- Bilirubin normal

- AST or ALT no greater than 2.5 times upper limit of normal

- Creatinine normal

- Creatinine clearance at least 60 mL/min

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- No other uncontrolled concurrent illness

- No ongoing or active infection

- No prior allergic reaction attributed to compounds of similar chemical or biologic
composition to imatinib mesylate

- No other malignancy within the past 5 years except basal cell skin cancer or
carcinoma in situ of the cervix

- No psychiatric illness or social situation that would preclude study compliance

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception during and for 1 week
after study

- No concurrent biologic agents

- No more than 2 prior chemotherapy regimens for metastatic disease

- Therapy with high-dose regimens or bone marrow transplantation considered 1

- At least 4 weeks since prior chemotherapy (6 weeks for carmustine or mitomycin) and

- No concurrent chemotherapy

- Prior hormonal therapy for stage IV disease and/or as adjuvant therapy allowed

- At least 4 weeks since prior radiotherapy and recovered

- Prior localized radiotherapy that does not influence the signal of the evaluable
lesion is allowed

- At least 2 weeks since prior minor surgery

- At least 4 weeks since prior major surgery

- Recovered from prior surgery

- Low-molecular weight heparin or heparin allowed for anticoagulation

- No concurrent warfarin

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No concurrent investigational therapies or agents

- No other concurrent anticancer therapy

- No concurrent intake of cola, orange juice, grapefruit, or orange or grapefruit

Type of Study:


Study Design:

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

Outcome Measure:

Objective tumor response (CR + PR), as determined by the RECIST criteria

Outcome Time Frame:

Up to 2 years

Safety Issue:


Principal Investigator

Massimo Cristofanilli

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

August 2002

Completion Date:

Related Keywords:

  • Male Breast Cancer
  • Recurrent Breast Cancer
  • Stage IV Breast Cancer
  • Breast Neoplasms
  • Breast Neoplasms, Male



M D Anderson Cancer Center Houston, Texas  77030