STUDY OF TAMOXIFEN AND EXEMESTANE MORE GNRH ANALOGUE AS ADJUVANT THERAPY FOR PREMENOPAUSIC WOMEN WITH BREAST CANCER WITH ENDOCRINE RESPONSE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

REPEC

Registry ID

PER-069-03

Enrollment

2639

Registered

2004-01-26

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C50 Cancer de mama

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Premenopausal women [estradiol (E2) in premenopausal ranges (according to institutional parameters) after surgery] Patients should be randomized within 12 weeks of definitive surgery.

Exclusion criteria

Exclusion criteria: not contemplated

Design outcomes

Primary

Measure	Time frame
First confirmation of relapse (local, regional, or distant), contralateral breast cancer, second primary tumor (non-breast), and / or death. NAME OF THE RESULT: Disease-free survival PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 1 ano	—

Secondary

Measure	Time frame
First confirmation of relapse (local, regional, or distant), contralateral breast cancer, second primary tumor (non-breast), and / or death. NAME OF THE RESULT: Disease-free survival PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 1 ano;Global survival (SG) is defined as the time from randomization to death from any cause. Locations of first failure to treatment. Late effects of early menopause. Incidence of primary seconds (non-breast) Causes of death without cancer event. NAME OF THE RESULT: Global survival Quality of life PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 1 year	—

Measure

Time frame

First confirmation of relapse (local, regional, or distant), contralateral breast cancer, second primary tumor (non-breast), and / or death. NAME OF THE RESULT: Disease-free survival PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 1 ano;Global survival (SG) is defined as the time from randomization to death from any cause. Locations of first failure to treatment. Late effects of early menopause. Incidence of primary seconds (non-breast) Causes of death without cancer event. NAME OF THE RESULT: Global survival Quality of life PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 1 year

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Countries

Australia, Canada, Japan, United States

Outcome results