Anastrozole and ZD1839 Compared With Fulvestrant and ZD1839 in Postmenopausal Women w/ Metastatic Breast Cancer

Not Recruiting

Trial ID: NCT00057941


This randomized phase II trial is studying how well giving gefitinib together with anastrozole works compared to giving gefitinib together with fulvestrant in treating postmenopausal women with recurrent or metastatic breast cancer. Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using anastrozole and fulvestrant may fight breast cancer by blocking the use of estrogen. Gefitinib (ZD1839) may stop the growth of cancer cells by blocking the enzymes necessary for their growth. It is not yet known whether gefitinib is more effective when combined with anastrozole or fulvestrant in treating breast cancer.

Official Title

A Randomized Phase II Trial of Combination Anastrozole (NSC #719344) Plus ZD1839 (Iressa, NSC #715055, IND #61187) and of Combination Fulvestrant (NSC #719276) Plus ZD1839 in the Treatment of Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer

Stanford Investigator(s)

Frank E. Stockdale
Frank E. Stockdale

Maureen Lyles D'Ambrogio Professor in the School of Medicine, Emeritus


Inclusion Criteria:

   - Patients must have estrogen and/or progesterone receptor positive histologically
   confirmed adenocarcinoma of the breast with measurable recurrent or metastatic
   carcinoma of the breast

   - Baseline measurements and evaluations of involved sites should be performed as close
   as possible to study entry, but must be within 4 weeks prior to randomization

   - Patients with available tissue blocks from either the primary or metastatic site must
   submit the tissue for EGFR analysis

   - All patients must be postmenopausal females defined by:

      - Prior bilateral oophorectomy or bilateral ovarian irradiation

      - No menstrual period for 12 months or longer. If age 55 years or less and on
      tamoxifen within the prior 6 months, must have an estradiol level in the
      postmenopausal range

   - Patients must not have had more than 2 prior chemotherapy regimens for metastatic
   disease and no chemotherapy within 3 weeks prior to randomization; no concurrent
   chemotherapy is allowed while on protocol therapy

   - Patients must not have prior hormonal therapy for metastatic disease; no prior therapy
   in the adjuvant setting with an estrogen receptor down-regulator (e.g. fulvestrant) or
   an aromatase inhibitor (e.g. anastrozole, letrozole, exemestane, aminoglutethamide);
   non-protocol concurrent hormonal therapy is not allowed

   - Patients must not have had prior therapy with agents that target EGFR

   - Previous, but not concomitant, therapy with trastuzumab (Herceptin) is allowed;
   patients must not receive trastuzumab (Herceptin) within 3 weeks prior to

   - Patients must have ECOG performance status of 0, 1, or 2

   - Neutrophils >= 1500/mm^3

   - Platelets >= 100,000/mm^3

   - Bilirubin =< 1.25 x upper limit of normal

   - SGPT (ALT) and SGOT (AST) =< 2.5 x upper limit of normal if no demonstrable liver
   metastases or =< 5 times upper limit of normal in the presence of liver metastases

   - Calculated creatinine clearance >= 30ml/min

   - INR, PT and PTT within normal range

   - Patients must not be receiving therapy with anticoagulants or have other
   contraindication to i.m. injections

   - Patients must not have a history of central nervous system metastasis

   - Patients may receive concurrent radiation therapy to painful sites of boney disease or
   areas of impending fracture as long as the radiation therapy is initiated prior to
   study entry and sites of measurable disease outside the radiation therapy port are
   available to follow; patient who have received prior radiation therapy must have
   recovered from toxicity of the prior radiation therapy

   - Patients must not take the following medications that may alter ZD1839
   pharmacokinetics while enrolled in this trial: phenytoin, carbamazapine,
   phenobarbitol, rifampicin, and St. John's Wort, oxcarbazepine, rifapentine, modafinil,
   and griseofulvin

   - Patients age =< 55 years must not be receiving LHRH agonists or antagonists within 3
   months prior to randomization

   - Patients who have an ocular inflammation or infection should be fully treated before
   entry into the trial; patients with a neuropathic keratopathy or diabetes or those
   with anterior basement membrane disease must be advised of the need for frequent
   opthalmalogic exams

   - Patients who continue to wear contact lenses must be advised that they have an
   increased risk of ocular events; the decision to wear contact lenses should be
   discussed with the patient's treating oncologist and ophthalmologist

   - Patients must not suffer from medical or psychiatric conditions that would interfere
   with protocol compliance, the ability to provide informed consent, or assessment of
   response or anticipated toxicities

   - Patients must be disease-free of prior invasive malignancies for > 5 years with the
   exception of curatively-treated basal cell or squamous cell carcinoma of the skin or
   carcinoma in situ of the cervix


drug: anastrozole

drug: fulvestrant

drug: gefitinib

other: laboratory biomarker analysis

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Nancy Mori

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