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Study Summary
No. DM01-173:.......Breast......Aman U. Buzdar......Breast Medical Oncology
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Study Summary Title
Study Summary
Number:		DM01-173
Study Title:RANDOMIZED DOUBLE-BLIND TRIAL IN POSTMENOPAUSAL WOMEN WITH PRIMARY BREAST CANCER WHO HAVE RECEIVED ADJUVANT TAMOXIFEN FOR 2-3 YEARS, COMPARING SUBSEQUENT ADJUVANT EXEMESTANE TREATMENT WITH FURTHER TAMOXIFEN
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Physician New Patient Referral
Name:Aman U. BuzdarPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Breast Medical OncologyReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-792-2817
Contact us about clinical trials
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General Information
Disease Group:BreastSupported By:Pharmacia & Upjohn
Phase of Study:Phase IIIReturn
Visit:		ROUTINE - NO EXTRA VISITS
Treatment
Agents:		Tamoxifen CitrateHome Care:NONE
Treatment Loc:outpatient
Estimated
Length of Stay
in Houston:		O
Description/
Intervention:		Unavailable
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Study Objectives / Outcomes
Unavailable
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Study Status Information
Study Activation / Registration Date:11/13/2001
IRB Review and Approval Date:06/20/2001
Study Type:Therapeutic
Recruitment Status:Closed
Projected Accrual:1,592
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:At diagnosis of breast cancer: histologically or cytologically confirmed unilateral adenocarcinoma of the breast, considered operable; ER status positive or unknown & has had adequate therapy for primary disease.

At randomization:pt must be postmenopausal & be receiving tamoxifen & treated continuously for between 2 & 3 yrs & 1 month with no more than 1 month break at any 1 time.

Tamoxifen started within 3 months of diagnosis or completion of chemo & pt is free from disease following treatment for primary disease.

Labs: normal Hb, WBC>/=4x10(9)/L; creatinine </=1.5ULN, & SGOT </=2.5ULN.

Pt must be accessible for follow-up for duration of the trial and give informed consent.

Pt entered into another trial of systemic therapy & completed the trial treatment are elig with written permission from study co-ordinator.
Exclusion Criteria:Unresectable breast cancer: pts not deemed to have had curative primary Tx and/or (1 of the these) inflammatory breast cx, histologically positive supraclavicular nodes, or ulceration/infiltration or skin mets.

ER neg. primary tumor.

Evidence of local relapse or distant mets (on chest x-raym scintigraphic bone scanning & liver ultrasonography/CT scanning) at any time.

Significant skeletal, cardiac or endocrine disorders.

Psychiatric or addictive disorders which could preclude obtaining informed consent.

Have received hormone replacement therapy within 4 wks of randomization.

Concomitant treatment with systemic corticosteroids for a prolonged period (>2wks).

Clinical evidence of severe osteoporosis and/or history of osteoporotic fracture.

Previous malignancies, except for basal cell carcinoma and CIS cervix.

Concomitant treatment with Warfarin.

Concomitant treatment with SERMS (selective estrogen receptor medulators).
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Links
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Results

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