Know Cancer

forgot password

An IDBBC Single Arm Phase II Trial Evaluating The Activity Of Iressa (ZD1839) In Metastatic Breast Cancer Patients Pretreated With An Antiestrogen And A Non-Steroidal Aromatase Inhibitor (Anastrozole Or Letrozole)

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

An IDBBC Single Arm Phase II Trial Evaluating The Activity Of Iressa (ZD1839) In Metastatic Breast Cancer Patients Pretreated With An Antiestrogen And A Non-Steroidal Aromatase Inhibitor (Anastrozole Or Letrozole)


- Determine the clinical benefit rate, defined as complete response, partial response, or
stable disease after at least 24 weeks, in patients receiving gefitinib for metastatic
breast cancer who progressed after prior antiestrogen and nonsteroidal aromatase
inhibitor therapy.

- Determine the best overall response rate of patients treated with this drug.

- Determine the progression-free survival of patients treated with this drug.

- Determine the duration of response in patients treated with this drug.

- Determine the safety of this drug in these patients.

OUTLINE: This is a nonrandomized, open-label, multicenter study.

Patients receive oral gefitinib once daily. Treatment continues in the absence of disease
progression or unacceptable toxicity.

Patients who go off study in the absence of disease progression are followed every 8 weeks
until disease progression.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed breast cancer

- Radiological and/or clinical evidence of metastatic disease

- Progressive disease after prior therapy with an antiestrogen (e.g., tamoxifen or
faslodex) and a nonsteroidal aromatase inhibitor (e.g., anastrozole or letrozole) in
the adjuvant and/or metastatic setting* NOTE: *Endocrine therapy must be the last
treatment before study entry

- Unidimensionally measurable disease

- No rapidly progressive visceral metastases

- No uncontrolled CNS metastases

- Hormone receptor status:

- Estrogen receptor and/or progesterone receptor positive



- 18 and over


- Not specified

Menopausal status

- Postmenopausal, defined as any of the following:

- Natural menopause with at least 1 year since last menses

- Radiation-induced oophorectomy with last menses more than 1 year ago

- Chemotherapy-induced menopause with 1 year since last menses and serum
follicle-stimulating hormone, luteinizing hormone, and plasma estradiol levels
in the postmenopausal range

- Surgical castration

Performance status

- ECOG 0-2

Life expectancy

- Not specified


- Not specified


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- Transaminases no greater than 2.5 times ULN

- No severe or uncontrolled hepatic disease


- No severe or uncontrolled renal disease


- No severe or uncontrolled cardiac disease


- No severe or uncontrolled respiratory disease

- No evidence of clinically active interstitial lung disease

- Asymptomatic chronic stable radiographic changes allowed


- No other malignancy within the past 5 years except adequately treated carcinoma in
situ of the cervix, contralateral breast cancer, or nonmelanoma skin cancer

- No psychological, familial, sociological, or geographical condition that would
preclude study compliance and follow-up

- No other severe or uncontrolled systemic disease

- No known hypersensitivity to any excipients of gefitinib

- No unresolved chronic toxicity greater than grade 2


Biologic therapy

- No concurrent biologic agents


- No more than 1 prior chemotherapy regimen for metastatic breast cancer

- No concurrent chemotherapy

Endocrine therapy

- See Disease Characteristics

- No concurrent hormonal therapy


- Prior radiotherapy allowed

- No concurrent radiotherapy to any metastatic site


- No surgery within 4 days after study drug administration


- No prior epidermal growth factor receptor inhibitor therapy

- More than 30 days since prior investigational drugs

- No concurrent use of any of the following:

- Phenytoin

- Carbamazepine

- Rifampin

- Phenobarbital

- Hypericum perforatum (St. John's Wort)

- No concurrent systemic retinoids

- No other concurrent investigational drugs or treatments

- No other concurrent anticancer treatments

- Concurrent bisphosphonates for the treatment and prevention of bony metastases are
allowed provided therapy was initiated before study enrollment* NOTE:
*Bisphosphonates may be initiated during study participation for the treatment of
hypercalcemia only

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Martine J. Piccart-Gebhart, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Institut Jules Bordet


United States: Federal Government

Study ID:




Start Date:

May 2003

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • recurrent breast cancer
  • Breast Neoplasms