Clinical Trial for Pre-Menopausal Women w/ BC

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

Status: Open

Principal Investigator(s):
- Robert Carlson (onc at Stanford)

Contact Info:
Christine Schurman, RN
TP: 650-723-8686

Contact Email: schurman@stanford.edu

Sites:

- Other

- Stanford Hospital

Objective and Design:
1.1 To evaluate the antitumor activity of Arimidex in combination with Zoladex in the treatment of premenopausal women with hormone receptor positive, metastatic breast cancer. This will be measured by the frequency of response and time to disease progression.

1.2 To assess the toxicity of combination Arimidex and Zoladex in the treatment of these patients.

1.3 To evaluate the effectiveness of combination Arimidex and Zoladex in the suppression of the hormone estradiol in the blood plasma of premenopausal women with hormnone receptor positive, metastatic breast cancer.

Major Disease Categories Under Investigation:

- Cancer (Adult)

Disease Subcategories Under Investigation:

- Breast Cancer

Phase(s):

- Phase II

Trial Type:

- Treatment

Ages:

- Adult (18 to 70 yrs of age)

Genders:

- Female

Eligibility Description:
1.1 Patients must have a progressive, measurable, and recurrent or metastatic cancer of the breast.

1.2 All patients must be female and premenopausal. Premenopausal
is defined as one of the following: (1) the patient has had a menstrual period in the past three months, or (2) is post-hysterectomy without removal of the ovaries, or (3) if tamoxifen within the past three months, the patient has premenopausal levels of estradiol in her blood.

1.3 Patients must be estrogen and/or progesterone
receptor positive.

1.4 No prior treatment with an aromatase inhibitor.

1.5 The patient has not undergone adjuvant chemotherapy within 6 months of study entry.

1.6 Patients must have adequate bone marrow, liver, and kidney function as measured by laboratory testing.

1.7 Patients with metastases of the breast cancer in the brain are ineligible.

1.8 Patients must not have received chemotherapy or hormone therapy three weeks prior to enrollment.

1.9 Patients who are pregnant or are breast-feeding are ineligible. The patient must be using effective contraception or not be of childbearing potential.

2.0 If the patient has had cancer other than breast, cervical, or skin cancer in the past 5 years, the patient is ineligible.

2.1 The patient must not have an acute, unresolved infection.

2.2 All patients must give signed written informed consent.