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Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women
This study is ongoing, but not recruiting participants.
First Received: September 13, 2005   Last Updated: July 2, 2008   History of Changes
Sponsors and Collaborators: Stanford University
AstraZeneca
Information provided by: Stanford University
ClinicalTrials.gov Identifier: NCT00186121
  Purpose

To evaluate the antitumor activity, toxicity, and effectiveness of the combination of Arimidex and Zoladex in the treatment of premenopausal women with hormone receptor positive metastatic carcinoma of the breast.


Condition Intervention
Breast Cancer
Drug: Anastrozole (Arimidex)
Drug: Goserelin (Zoladex)

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Goserelin Anastrozole
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment
Official Title: A Phase II Trial of Arimidex Plus Zoladex in the Treatment of Hormone Receptor Positive, Metastatic Carcinoma of the Breast in Premenopausal Women

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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 positive, metastatic carcinoma of the breast.
  • To evaluate the toxicity of combination Arimidex and Zoladex in the treatment of premenopausal women with hormone receptor positive, metastatic carcinoma of the breast.
  • 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.

Secondary Outcome Measures:
  • Clinical benefit and survival will also be assessed as secondary endpoints.

Estimated Enrollment: 30
Study Start Date: October 2000
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00186121

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
AstraZeneca
Investigators
Principal Investigator: Robert W Carlson Stanford University
  More Information

No publications provided

Study ID Numbers: BRSMTS0001, 1033VS0012, 75597, BRSMTS0001, NCT00186121
Study First Received: September 13, 2005
Last Updated: July 2, 2008
ClinicalTrials.gov Identifier: NCT00186121     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Anastrozole
Skin Diseases
Antineoplastic Agents, Hormonal
Estradiol valerate
Goserelin
Breast Neoplasms
Estradiol 17 beta-cypionate
Hormones
Estradiol
Carcinoma
Estradiol 3-benzoate
Aromatase Inhibitors
Polyestradiol phosphate
Breast Diseases

Additional relevant MeSH terms:
Anastrozole
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Goserelin
Breast Neoplasms
Enzyme Inhibitors
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Aromatase Inhibitors
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009