CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 31 enrolled
Drug / intervention
Exemestane +2 moredrug
Likely dose
Exemestane 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00941330
NCT00941330Phase 2Completed

Randomized Phase II Trial of Pre-Operative Docetaxel-Cytoxan (TC) or Exemestane in Patients With Hormone Receptor-Positive Breast Cancers With Recurrence Scores Greater Than 10 (≥ 11) and Less Than 25 (≤ 24)

Emory University·interventional·Posted Jul 17, 2009·Updated Apr 10, 2017

In Brief

A Phase 2 clinical trial evaluating Exemestane, Docetaxel, and 1 other intervention for Breast Cancer. Completed, enrolled 31 participants across 3 sites.

Detailed Summary

The patients are being asked to take part in this study because they have a hormone receptor-positive breast cancer (contains estrogen and/or progesterone receptors) and their doctor has told them that they have an option to receive chemotherapy or hormonal therapy before surgery. The purpose of this study is to assess if chemotherapy using docetaxel and cytoxan (TC) or hormonal therapy using exemestane can shrink the size of their breast tumor and allow them to preserve the breast or have less extensive surgery on their breast.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsPfizer

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 17, 2009
Enrollment StartJul 1, 2009
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 17.0 years ago

Interventions

Exemestanedrug

25 mg daily by mouth for 6 to 12 months.

Docetaxeldrug

Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).

Cytoxandrug

Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).