Study of Physiological and High Dose Estradiol in the Treatment of Hormone Receptor Positive Metastatic Breast Cancer
|ClinicalTrials.gov Identifier: NCT00324259|
Recruitment Status : Completed
First Posted : May 10, 2006
Results First Posted : February 16, 2015
Last Update Posted : February 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Drug: Estradiol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Randomized Study of Physiological (6 mg Daily) and High Dose (30 mg Daily) Estradiol in the Treatment of Hormone Receptor Positive Metastatic Breast Cancer|
|Study Start Date :||August 2004|
|Primary Completion Date :||March 2011|
|Study Completion Date :||August 2014|
Active Comparator: Arm 1 (6 mg estradiol)
6 mg of estradiol daily (2 mg tid).
Active Comparator: Arm 2 (30 mg estradiol)
30 mg of estradiol. (10 mg tid)
- Clinical Benefit Rate (CR Plus PR Plus SD) [ Time Frame: 24 weeks after start of treatment ]
Complete response (CR) + partial response (PR) + stable disease (SD) using RECIST 1.0
CR = disappearance of all target lesions
PR = at least a 30% decrease in the sum of the longest diameter of target lesions taking as reference the baseline sum longest diameter
SD = neither sufficient shrinkage to quality for PR nor sufficient increase to qualify for progressive disease
SD is defined as lack of disease progression by 24 weeks.
- Progression-free Survival (PFS) [ Time Frame: Up to 48 weeks ]
Defined as the time from treatment initiation to disease progression or death.
Time of last observation for patients remaining in the study and the time at which dose reductions, study drug termination, and withdrawal of consent occurred were treated as censored data.
Indicated as number of participants who had not progressed at 12 weeks, 24 weeks, 36 weeks, and 48 weeks.
Progression per RECIST 1.0 = at least a 20% increase in the sum of the longest diameter of target lesions taking as references the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
- Quality of Life [ Time Frame: Baseline and Day 28 ]
Surveyed using a 6 item estrogen adverse effect questionnaire (headaches, bloating, breast tenderness, retention of fluid, nausea, and vomiting).
Used a 5-point scale ranging from 0 (not at all) to 4 (very much).
The scores from the 6 estrogen adverse effect items were summed to produce a single score, ranging from 0-24, with higher scores indicating higher adverse effects.
- Quality of Life (FACT-B Mean Score) [ Time Frame: Day 28 ]
Surveyed using the multidimensional Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire
The FACT-B (version 4) questionnaire consists of 36 items with five-point scale, ranging from 0-4, where a total score ranges from 0-144 and higher scores indicate better QoL. The total FACT-B score is the sum of scores for five subscales including: physical well-being (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and specific breast cancer concerns (9 items).
- Frequency of Response to Re-treatment With the Same Aromatase Inhibitor That Immediately Preceded Treatment With Estradiol on Protocol. [ Time Frame: 12 weeks post-treatment termination ]Best overall response
- Frequency of Response to Re-treatment With Estradiol for Patients Who Have a Secondary Response to an Aromatase Inhibitor After the First Response to Estradiol. [ Time Frame: Every 3 months ]
- Overall Survival (OS) [ Time Frame: Until patient death ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00324259
|United States, Illinois|
|University of Chicago|
|Chicago, Illinois, United States, 60637|
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, North Carolina|
|University of North Carolina Breast Clinic|
|Chapel Hill, North Carolina, United States, 27599|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Case Western University|
|Cleveland, Ohio, United States, 44106|
|Cleveland Clinic, Lerner College of Medicine, Case Western Reserve University|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Matthew Ellis, M.D., Ph.D.||Washington University School of Medicine|