Exemestane vs Tamoxifen for Breast Cancer
(BabyTEARS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares the effectiveness and safety of two medications, exemestane and tamoxifen, in preventing breast cancer in post-menopausal women at high risk. Exemestane, an aromatase inhibitor, reduces estrogen production, while tamoxifen, a selective estrogen receptor modulator, blocks estrogen's effects on breast tissue. Women who have been post-menopausal for at least a year, have a recent diagnosis of certain breast conditions, or have a family history that increases their risk might be suitable for this trial. Participants will take one of the medications every other day for a year, with regular check-ups to monitor progress. As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group of people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown exemestane to be generally safe. For instance, one study found that 88% of people taking exemestane experienced side effects, similar to those taking a placebo, indicating it is well-tolerated overall. Only one very serious side effect, a blood clot, was reported. Exemestane is also already used to lower breast cancer risk in some women.
Research on tamoxifen shows it also reduces breast cancer risk and is widely used for this purpose. Some studies have reported side effects like hot flashes. Despite this, tamoxifen has effectively reduced the risk of dying from breast cancer over long periods.
Both treatments have been used for a long time and have proven safe for many women. This trial specifically examines low doses, which might result in fewer side effects.12345Why are researchers excited about this trial's treatments?
Researchers are excited about using low-dose Exemestane and Tamoxifen for breast cancer because these treatments aim to reduce side effects while maintaining effectiveness. Traditional breast cancer treatments like full-dose Tamoxifen and aromatase inhibitors often come with significant side effects. By administering lower doses of these drugs every other day, the goal is to minimize side effects like hot flashes and bone density loss, which can significantly impact patients' quality of life. This approach could offer a more tolerable option for managing breast cancer, keeping patients healthier and more comfortable during treatment.
What evidence suggests that this trial's treatments could be effective for breast cancer?
This trial will compare low-dose Exemestane with low-dose Tamoxifen for breast cancer. Research has shown that Exemestane can significantly lower the risk of breast cancer in postmenopausal women at higher risk. When taken after Tamoxifen treatment, it can reduce the chance of cancer returning by half. Exemestane also improves survival rates, offering a 19% lower risk of breast cancer compared to some other treatments.
Conversely, studies have found that Tamoxifen can reduce the risk of dying from breast cancer by about 57% and decrease the chance of developing invasive breast cancer by 40%. It is particularly effective for tumors sensitive to estrogen, which is common in breast cancer. Long-term studies have proven Tamoxifen's benefits in lowering recurrence and improving survival. Participants in this trial will be randomized to receive either low-dose Exemestane or low-dose Tamoxifen to evaluate their effectiveness.12678Who Is on the Research Team?
Judy Garber, MD. MPH
Principal Investigator
Dana-Farber Cancer Institute
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either low-dose exemestane or low-dose tamoxifen for 12 months with regular in-clinic visits
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Exemestane
- Tamoxifen
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will be randomized 1:1 with a permuted-block technique and stratified by center and will complete: * Baseline visit with assessments * Predetermined dose of Tamoxifen 1x on every odd day for 12 months * 3 month in-clinic visit * 6 month in-clinic visit * 9 month in-clinic visit * 12 month end of intervention in-clinic visit * Follow up for 12 months
Participants will be randomized 1:1 with a permuted-block technique and stratified by center and will complete: * Baseline visit with assessments * Predetermined dose of Exemestane 1x on every odd day for 12 months * 3 month in-clinic visit * 6 month in-clinic visit * 9 month in-clinic visit * 12 month end of intervention in-clinic visit * Follow up for 12 months
Find a Clinic Near You
Who Is Running the Clinical Trial?
Dana-Farber Cancer Institute
Lead Sponsor
Breast Cancer Research Foundation
Collaborator
Citations
Outcomes of Anastrozole, Letrozole, and Exemestane in ...
This comparative effectiveness research compares disease-free survival and overall survival 5 and 8 years after the initiation of endocrine ...
Outcomes of Anastrozole, Letrozole, and Exemestane in ...
This comparative effectiveness research compares disease-free survival and overall survival 5 and 8 years after the initiation of endocrine ...
Exemestane Following Tamoxifen Reduces Breast ...
This translated to a 2.4 percent absolute improvement in survival. Women in the exemestane group also had a 19 percent lower risk of a breast ...
Long-term efficacy and safety of exemestane in the treatment ...
As chemoprevention, exemestane significantly reduces the incidence of breast cancer in “at-risk” postmenopausal women. Exemestane is associated with myalgias ...
Mature results of a randomized phase II multicenter study ...
Fifty-seven per cent of exemestane- and 42% of tamoxifen-treated patients experienced clinical benefit, defined as complete or partial response, or disease ...
Exemestane Reduces Breast Cancer Risk in High- ...
At 3 years of follow-up, women who took exemestane were 65 percent less likely than women who took a placebo to develop breast cancer. This is ...
Exemestane for Breast-Cancer Prevention in ...
Study accrual and safety data were reviewed every 6 months by an independent data and safety monitoring commit-.
Exemestane for Breast-Cancer Prevention in ...
Exemestane significantly reduced invasive breast cancers in postmenopausal women who were at moderately increased risk for breast cancer.
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