|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
10 December 2012 |
|
Main ID: |
NCT00186121 |
|
Date of registration:
|
13/09/2005 |
|
Primary sponsor: |
|
|
Public title:
|
Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women
|
|
Scientific title:
|
A Phase II Trial of Arimidex Plus Zoladex in the Treatment of Hormone Receptor Positive, Metastatic Carcinoma of the Breast in Premenopausal Women |
|
Date of first enrolment:
|
October 2000 |
|
Target sample size:
|
30 |
|
Recruitment status: |
Active, not recruiting |
|
URL:
|
http://clinicaltrials.gov/show/NCT00186121 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
United States
| | | | | | | |
|
Contacts
|
|
Name:
|
Robert W Carlson |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Stanford University |
| | |
|
Key inclusion & exclusion criteria
|
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
following:
- 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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Breast Cancer
|
|
Intervention(s)
|
|
Drug: Anastrozole (Arimidex)
|
|
Drug: Goserelin (Zoladex)
|
|
Primary Outcome(s)
|
|
To assess the effectiveness of the combination of Arimidex and Zoladex in suppression of plasma estradiol in premenopausal women with hormone receptor positive, premenopausal breast cancer.
[Time Frame: 6 months]
|
|
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
[Time Frame: every 3 months]
|
|
To evaluate the toxicity of combination Arimidex and Zoladex in the treatment of premenopausal women with hormone receptor positive, metastatic carcinoma of the breast.
[Time Frame: every 3 months]
|
|
Secondary Outcome(s)
|
|
Clinical benefit and survival will also be assessed as secondary endpoints.
[Time Frame: every 3 months]
|
|
Secondary ID(s)
|
|
1033VS0012
|
|
75597
|
|
BRSMTS0001
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|