Estradiol Suppression for the Treatment of Metastatic Breast Cancer in Premenopausal Women

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Melinda Telli, Stanford University
ClinicalTrials.gov Identifier:
NCT00186121
First received: September 13, 2005
Last updated: July 24, 2013
Last verified: July 2013
  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)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


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 [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical benefit and survival will also be assessed as secondary endpoints. [ Time Frame: every 3 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: October 2000
Study Completion Date: June 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arimidex plus Zoladex Drug: Anastrozole (Arimidex) Drug: Goserelin (Zoladex)

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Melinda Telli, MD Stanford University
  More Information

No publications provided

Responsible Party: Melinda Telli, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00186121     History of Changes
Other Study ID Numbers: BRSMTS0001, 1033VS0012, 75597, BRSMTS0001
Study First Received: September 13, 2005
Last Updated: July 24, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 21, 2014