Goserelin Acetate for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether injections of the drug goserelin acetate in the upper gluteal region are as effective as abdominal injections in suppressing ovarian function in premenopausal women with certain types of breast cancer. Goserelin acetate, a hormone therapy, helps stop cancer cells from growing by lowering estrogen levels. Participants with hormone receptor-positive breast cancer who are already receiving ovarian function suppression with goserelin might be suitable for this trial. The study includes two groups receiving injections in different locations to compare effectiveness. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.
Is there any evidence suggesting that this trial's treatment is likely to be safe?
Research has shown that goserelin acetate is generally well-tolerated by patients with breast cancer. In a study comparing different doses, patients taking either the monthly 3.6 mg dose or the 3-month 10.8 mg dose experienced similar safety outcomes, with no major differences in side effects. This suggests it is safe to use.
The FDA has already approved goserelin acetate for treating prostate cancer and managing symptoms of advanced breast cancer, indicating its safety for these uses. This approval can be reassuring. However, since this trial is in phase 2, researchers are still collecting more detailed safety information.
In summary, while current data and FDA approval for other uses generally consider goserelin acetate safe, ongoing research will provide more specific safety details for this treatment plan.12345Why are researchers excited about this trial?
Goserelin acetate is unique because it offers a different approach to treating breast cancer by targeting hormonal pathways. Unlike standard treatments such as tamoxifen or aromatase inhibitors, which block estrogen receptors or decrease estrogen production, goserelin acetate works by suppressing the release of hormones that stimulate cancer growth. This mechanism can be particularly beneficial for premenopausal women, as it effectively reduces estrogen levels. Additionally, goserelin acetate is administered via subcutaneous injection, which can offer a more consistent delivery compared to oral medications, potentially improving treatment adherence and effectiveness. Researchers are excited about these features because they address some limitations of current therapies and may offer a new avenue for managing hormone-sensitive breast cancer.
What evidence suggests that goserelin acetate might be an effective treatment for breast cancer?
Research has shown that goserelin acetate effectively treats hormone receptor-positive breast cancer. Studies indicate that adding goserelin can lower the chance of cancer recurrence by 13% and reduce deaths after recurrence by 15%. In women with breast cancer, goserelin reduces hormones like estrogen, which can slow or stop cancer cell growth. One study found that goserelin works as well as traditional chemotherapy in stopping periods, effectively suppressing ovarian function. Overall, goserelin is a proven option for managing breast cancer by suppressing ovarian function. Participants in this trial will receive goserelin acetate in different dosing schedules to evaluate its effectiveness and safety.13567
Who Is on the Research Team?
Karthik V. Giridhar, MD
Principal Investigator
Mayo Clinic
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
Treatment
Participants receive goserelin acetate injections in the abdomen or upper gluteal region for ovarian function suppression
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for adverse events and quality of life changes
What Are the Treatments Tested in This Trial?
Interventions
- Goserelin Acetate
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Patients receive goserelin acetate SC in the abdomen on day 1 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive goserelin acetate SC in the upper gluteal region on day 1 of each cycle. Cycles repeat every 84 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection on study.
Patients receive goserelin acetate SC in the abdomen on day 1 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients receive goserelin acetate SC in the upper gluteal region on day 1 of each cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection on study.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor
Citations
Long-term Effectiveness of Adjuvant Goserelin in ... - PMC - NIH
The analysis revealed statistically significant reductions in recurrence and death after recurrence of 13% and 15%, respectively, with the addition of an LHRH ...
Real-world effectiveness of goserelin 10.8-mg compared to ...
This RWS validated the non-inferiority of goserelin 10.8-mg 3-monthly to 3.6-mg monthly in Chinese patients with HR+ breast cancer.
Treatment Patterns of Goserelin 3.6 mg Once Every 4 ...
This retrospective analysis of US real-world data described the demographics and patterns of goserelin treatment of women with breast cancer.
Press Release
... outcomes among breast cancer patients treated with goserelin 3.6 mg and 10.8 mg. The primary outcome was the real-world event-free survival ...
Goserelin 3-month depot shows non-inferiority to the ... - PMC
This real-world analysis indicates that 3-month goserelin 10.8 mg is non-inferior to monthly 3.6 mg among premenopausal women with breast cancer in terms of 12 ...
HR+ breast cancer | ZOLADEX® (goserelin implant)
According to ClinicalTrials.gov, 139 studies have been registered that included goserelin acetate and an evaluation of breast cancer outcomes. ... IMPORTANT ...
NCCN Updates Breast Cancer Guidelines to Include ...
The ORR was 23.9% vs 26.9% in the 10.8 mg vs 3.6 mg arms, respectively, resulting in a treatment difference of -3.0% (95% CI, −15.5% to 9.7%).
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