ZOLADEX for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests ZOLADEX, a medication designed to reduce ovarian activity in women with advanced breast cancer. Researchers aim to assess its effectiveness in suppressing ovarian function by measuring luteinizing hormone (LH) levels. Women with advanced or metastatic breast cancer, untreatable by surgery or radiation, may be suitable candidates, particularly if their cancer is hormone-driven and they have not previously used hormone treatments. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this potentially groundbreaking therapy.
Is there any evidence suggesting that ZOLADEX is likely to be safe for humans?
Research has shown that ZOLADEX (goserelin) is generally well-tolerated for treating breast cancer. One study found the 10.8 mg dose to be as effective as the 3.6 mg dose. Another study reported a lower rate of ovarian failure, where the ovaries stop working, in patients taking ZOLADEX compared to those receiving only chemotherapy.
However, some side effects require attention. Some individuals have experienced allergic reactions throughout the body and severe allergic reactions. These reactions are serious but uncommon.
Overall, ZOLADEX is an approved treatment for breast cancer, indicating it is safe for many patients. However, like all treatments, it may not be suitable for everyone. Always discuss any concerns with a healthcare provider.12345Why do researchers think this study treatment might be promising for breast cancer?
ZOLADEX is unique because it targets hormone receptor-positive breast cancer by acting as a gonadotropin-releasing hormone (GnRH) agonist, which helps to reduce estrogen levels in the body. This is different from the standard treatments like tamoxifen or aromatase inhibitors, which work by blocking estrogen receptors or decreasing estrogen production. Researchers are excited about ZOLADEX because it offers a different approach by directly suppressing ovarian function, which can be particularly beneficial for premenopausal women. This method may provide an effective alternative for those who do not respond well to conventional hormone therapies.
What evidence suggests that ZOLADEX might be an effective treatment for breast cancer?
Research has shown that ZOLADEX, also known as goserelin, effectively treats breast cancer. Studies have found it significantly reduces the chances of cancer recurrence and the risk of death after recurrence. In this trial, participants will receive a 10.8 mg dose of ZOLADEX on Day 1 and Day 85. ZOLADEX has proven to work as well as the 3.6 mg dose given monthly for hormone receptor-positive breast cancer. In another study, 95% of patients who took goserelin stopped having periods, a desired effect in hormone therapy for breast cancer. Overall, these findings suggest that ZOLADEX is a promising treatment option for managing breast cancer by effectively stopping ovarian function.25678
Who Is on the Research Team?
Christine Fredericks
Principal Investigator
TerSera Therapeutics LLC
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 10.8 mg ZOLADEX on Day 1 and Day 85 to evaluate ovarian suppression by measuring LH levels
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ZOLADEX
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants will receive 10.8 mg ZOLADEX on Day 1 and Day 85.
Find a Clinic Near You
Who Is Running the Clinical Trial?
TerSera Therapeutics LLC
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 ...
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.
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.
Press Release
"ZOLADEX 3.6 mg given every 4 weeks is the only FDA-approved GnRHa for women with breast cancer. Our data suggests that the 10.8 mg dose given ...
Efficacy and safety | ZOLADEX® (goserelin implant)
On the basis of interim data from 124 women, the best objective response (CR+PR) for the ZOLADEX group was 22% vs 12% for the oophorectomy group. The median ...
Phase 3, open-label, randomized study comparing 3-monthly ...
A regimen of 3-monthly goserelin 10.8 mg demonstrated non-inferiority compared with monthly goserelin 3.6 mg for PFS rate at 24 weeks.
Goserelin for Ovarian Protection during Breast-Cancer ...
Among 135 with complete primary end-point data, the ovarian failure rate was 8% in the goserelin group and 22% in the chemotherapy-alone group ( ...
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%).
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.