Return to Results

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 Postmeno

new search

Trial Conditions
  • Breast Cancer
What is the purpose of this trial?

RATIONALE: 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. PURPOSE: 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.

Date & Status

Active, not recruiting

Who can Participate?


18 and older



Inclusion criteria:

- Histologically confirmed adenocarcinoma of the breast (Recurrent or metastatic

- Measurable disease

- Patients with available tissue blocks from either the primary or metastatic site must
submit the tissue for epidermal growth factor receptor analysis

- Estrogen and/or progesterone receptor positive

- Age>=18

- Female

- Postmenopausal, defined by 1 of the following:

- Prior bilateral oophorectomy or bilateral ovarian irradiation

- No menstrual period for at least 12 months

NOTE: If age 55 and under and on tamoxifen within the past 6 months, must have an
estradiol level in the postmenopausal range

- ECOG performance status of 0-2

- Adequate hematopoietic, hepatic, renal functions defined by the following within 2
weeks prior to randomization:

- Neutrophil count at least 1,500/mm^3

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

- Bilirubin no greater than 1.25 times upper limit of normal (ULN)

- Serum glutamic-pyruvic transaminase (ALT) and Serum glutamic-oxaloacetic (AST)
no greater than 2.5 times ULN (5 times ULN if liver metastases are present)

- International normalized ratio of prothrombin time (INR), prothrombin time (PT),
and partial thromboplastin time (PTT) normal

- Creatinine clearance at least 30 mL/min

- More than 3 weeks since prior trastuzumab (Herceptin®)

- More than 3 weeks since prior chemotherapy

- More than 3 months since prior luteinizing hormone-releasing hormone agonists or
antagonists (patients 55 years old and under)

- Recovered from prior radiotherapy

- Concurrent radiotherapy to painful sites of bony disease or areas of impending
fracture is allowed provided the following conditions are met:

- Therapy was initiated prior to study entry

- Sites of measurable disease outside the radiotherapy port are available for
disease evaluation

- Concurrent bisphosphonates for hypercalcemia or bone metastases are allowed

Exclusion Criteria:

- Pregnant or nursing

- Untreated ocular inflammation or infection

- Medical or psychiatric condition that would preclude study compliance, ability to
give informed consent, or assessment of response or anticipated toxic effects

- History of central nervous system (CNS) metastasis

- Other invasive malignancies within the past 5 years except curatively treated basal
cell or squamous cell skin cancer or carcinoma in situ of the cervix

- Contraindication to intramuscular injections

- More than 2 prior chemotherapy regimens for metastatic disease

- Prior hormonal therapy for metastatic disease

- Prior estrogen receptor down-regulators (e.g., fulvestrant) in the adjuvant setting

- Prior aromatase inhibitors (e.g., anastrozole, letrozole, exemestane, or
aminoglutethimide) in the adjuvant setting

- Prior agents that target epidermal growth factor receptors

- Other concurrent hormonal therapy

- Concurrent chemotherapy

- Concurrent trastuzumab

- Concurrent cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inhibitors
(e.g., ketoconazole, erythromycin, or verapamil)

- Concurrent anticoagulants, except for thrombotic events in patients in arm I

- Concurrent medications that would alter the pharmacokinetics of gefitinib (e.g.,
phenytoin, carbamazepine, phenobarbital, rifampin, Hypericum perforatum [St. John's
wort], oxcarbazepine, rifapentine, modafinil, and griseofulvin)

Gender: Female
Steward Physician(s)
  • Robert W. Carlson, MD
  • Morton Hospital - Active, not recruiting
Trial Interventions
  • anastrozole
  • fulvestrant
  • gefitinib
Physician Researcher

Investigator Name:

  • Robert W. Carlson, MD

Other Information

Sponsor: National Cancer Institute (NCI)
Phase: Phase 2
Trial ID: NCT00057941
Volunteers:  Not Accepting Healthy Volunteers

new search

Connect with Steward

Visit Our Twitter Feed Visit Our Facebook Page Email This Page Print This Page

Subscribe to our patient e-newsletter

Copyright © 2015 Steward Health Care
Connect Healthcare Panacea CMS Solutions