Hormone Therapy for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how aromatase inhibitors, a breast cancer treatment, affect blood sugar control and the risk of developing diabetes. Participants will be divided into groups: some women will start aromatase inhibitors, others will begin Tamoxifen (another breast cancer treatment), and a group of healthy post-menopausal women will participate for comparison. The trial targets post-menopausal women with hormone receptor-positive breast cancer or ductal carcinoma in situ, where abnormal cells are found in the milk ducts. Women with diabetes or those taking medications affecting blood sugar are not eligible. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.
Will I have to stop taking my current medications?
The trial excludes participants who are on medications that could affect glucose metabolism, so you may need to stop taking such medications. It's best to discuss your current medications with the trial team to see if they are allowed.
Is there any evidence suggesting that the aromatase inhibitor treatment is likely to be safe for humans?
Studies have shown that aromatase inhibitors, a type of hormone therapy, are generally safe for treating breast cancer. These drugs have been linked to positive outcomes, such as lower risks of death from any cause and specifically from breast cancer. Research also shows that aromatase inhibitors can reduce the chance of cancer returning by about 40% when used for around five years.
However, these treatments, while effective, can have side effects. Some studies have highlighted potential risks to heart health. Despite these concerns, the overall safety of aromatase inhibitors is well-documented, which is why they are commonly used in breast cancer treatment today.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to uncover how aromatase inhibitor therapy, commonly used in cancer treatment, impacts glucose homeostasis and diabetes risk. Unlike traditional diabetes studies focusing directly on blood sugar levels or insulin sensitivity, this trial explores a potential link between hormone therapy and metabolic changes. By collecting blood samples, performing glucose tests, and analyzing body composition, researchers hope to reveal new insights into how these inhibitors might affect diabetes risk, potentially leading to more personalized treatment plans for patients undergoing cancer therapy.
Who Is on the Research Team?
Kalpana Muthusamy, MBBS, MD
Principal Investigator
Mayo Clinic in Rochester
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants undergo a history, physical examination, and a blood collection for fasting glucose and Hemoglobin A1C (HbA1c)
Observational Period
Participants are monitored for glucose homeostasis and contacted at 3 and 6 months to confirm continued use of endocrine therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Aromatase Inhibitor
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Patients undergo blood sample collection, glucose testing, DEXA scan to measure body composition, complete a questionnaire and have their medical records reviewed on study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Citations
Long-term safety of aromatase inhibitors in the treatment of ...
Anastrozole and letrozole were shown to be superior to tamoxifen in terms of disease-free survival, time to recurrence, time to distant recurrence, and ...
Aromatase Inhibitors and the Risk of Cardiovascular ...
These drugs have been associated with favorable clinical outcomes, including decreased risks of all-cause and breast cancer–related mortality, ...
Oestradiol and breast cancer prevention: a 40 year history ...
An overview of the now large number of trials showed that 5 years' treatment reduced the risk of breast cancer recurrence by about 40% and the ...
Duration of Adjuvant Aromatase-Inhibitor Therapy in ...
No between-group difference was noted for overall survival at 8 years (87.5% in the 2-year group and 87.3% in the 5-year group), with a hazard ...
Use of anastrozole for breast cancer prevention (IBIS-II)
Two large clinical trials have shown a reduced rate of breast cancer development in high-risk women in the initial 5 years of follow-up after use of aromatase ...
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