A Phase 3 interventional study of anastrozole and placebo in Breast Cancer, sponsored by Queen Mary University of London. Completed at 74 sites in 14 countries. Open to female participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-06.
Sponsored by Queen Mary University of London · Phase 3, Interventional, and Prevention
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Anastrozole may be effective in preventing breast cancer.
PURPOSE: This randomized clinical trial is studying how well anastrozole works in preventing breast cancer in postmenopausal women who are at increased risk for the disease.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Participants are stratified according to participating center. Participants are randomized to 1 of 2 treatment arms.
Participants are followed for at least a further 5 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
ACCRUAL: A total of 3,864 participants were recruited for this study over 10 years.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 3,864 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Queen Mary University of London is the lead sponsor of 253 studies on the registry; 58 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Meets at least 1 of the relative risk factors based on age as follows:
45 to 70 years of age:
Two or more first- or second-degree relatives who developed breast cancer or ovarian cancer
60 to 70 years of age:
40 to 44 years of age:
All age groups (40 to 70 ears of age) with a 10-year risk > 5% who do not fit into the above categories are allowed
The following prior breast conditions are allowed (for all age groups):
Hormone receptor status:
For patients with prior DCIS, estrogen- or progesterone-receptor status must have been positive
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
, defined as at least 1 of the following:
Performance status
Hematopoietic
Hepatic
Renal
Other
No evidence of osteoporosis or fragility fractures within the spine
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
anastrozole 1mg
Drug: anastrozole
anastrozole 1mg PLACEBO
Drug: placebo
aromatase inhibitor
Also known as: Arimidex
Arimidex placebo
Development of histologically confirmed breast cancer, both invasive and non-invasive with median follow-up at 5 years
Time frame: Dec 2013
Breast cancer mortality with median follow-up at 10 years
Time frame: Dec 2018
The record gives a start of Sep 2003, a primary completion of Dec 2013 and a completion of May 2021. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Anastrozole
Queen Mary University of London →