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A Phase II Trial of Arimidex Plus Zoladex in the Treatment of Hormone Receptor Positive, Metastatic Carcinoma of the Breast in Premenopausal Women

18 Years
70 Years
Open (Enrolling)
Breast Cancer

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Trial Information

A Phase II Trial of Arimidex Plus Zoladex in the Treatment of Hormone Receptor Positive, Metastatic Carcinoma of the Breast in Premenopausal Women

Inclusion Criteria:

- Patients must have a histologically confirmed, bi-dimensionally
measurable, recurrent or metastatic carcinoma of the breast that is progressive.

- All patients must be female and premenopausal. Premenopausal is defined as either:
(1) last menstrual period within 3 months, or (2) post-hysterectomy without bilateral
oophorectomy and with FSH in the premenopausal range, or, (3) if on tamoxifen within
the past 3 months, a plasma estradiol in the premenopausal range.

- Patients must have either positive estrogen and/or progesterone receptor
determination by IHC or competitive binding assay on metastatic disease, or if not
performed on their metastatic disease a positive result on their primary breast
cancer specimen.

- No prior treatment with an aromatase inhibitor or inactivator.

- No prior treatment with an LH/RH agonist/antagonist.

- No adjuvant chemotherapy within 6 months of study entry.

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

- Patients must have adequate bone marrow, hepatic, and renal function defined by the

- Granulocytes > 1500/mm^3

- Platelets > 100,000/mm^3

- SGOT < 2.5x upper limit of normal

- Total bilirubin < 1.5 mg/dL

- Patients with central nervous system metastasis or lymphangitic pulmonary metastasis
are not eligible.

- Patients must not have received chemotherapy or hormonal therapy for at least 3 weeks
prior to enrollment.

- Patients may receive irradiation to bony sites of disease for pain control or for
prevention of fracture, but the irradiated site(s) will NOT be considered evaluable
for disease response.

- Patients who are pregnant or lactating are ineligible. Must be using effective
contraception or not be of childbearing potential.

- Patients must not have had an active malignancy other than breast cancer, in situ
carcinoma of the cervix, or non-melanomatous skin cancers in the past 5 years.

- No active, unresolved infection.

- All patients must give signed written informed consent.

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the antitumor activity, as measured by frequency of objective response and time to progression, of combination Arimidex and Zoladex in the treatment of premenopausal women with hormone receptor

Outcome Time Frame:

every 3 months

Safety Issue:


Principal Investigator

Robert W Carlson

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

October 2000

Completion Date:

December 2017

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



Stanford University School of Medicine Stanford, California  94305-5317