Now Enrolling: A Breast Cancer Study focused on reducing injections
The Bridging Study is seeking participants to join a clinical study for premenopausal women with HR+/HER2- advanced breast cancer.
About the Bridging Study
The Bridging Study is evaluating ZOLADEX® (goserelin implant) 10.8 mg, a prescription medicine that works by temporarily suppressing ovarian estrogen production. Estrogen can help fuel the growth of hormone receptor-positive (HR+) breast cancer.
ZOLADEX is an approved medication used worldwide for more than 35 years to treat several conditions, including advanced and metastatic breast cancer. In the United States, ZOLADEX® (goserelin implant) 3.6 mg, given once a month, is approved by the Food and Drug Administration (FDA) to treat advanced HR+ breast cancer. This study is being conducted to see whether a longer-acting formulation, ZOLADEX 10.8 mg, given once every 3 months, works similarly to the monthly 3.6 mg dose and may reduce how often the medicine needs to be given. ZOLADEX 10.8 mg, given once every 3 months, is not approved by the FDA to treat advanced HR+ breast cancer and is therefore considered investigational in this study.
Who Can Join the Bridging Study?
You May Be Eligible to Participate if You:
- Are 18 to 55 years of age
- Are premenopausal
- Have been diagnosed with advanced or metastatic HR+/HER2– breast cancer
Other requirements apply, which the study doctor will discuss with you.
If You Qualify and Decide to Participate:
- All study-related procedures and ZOLADEX 10.8 mg (study drug) will be provided at no cost
- A study doctor will closely monitor you, your symptoms, and your overall health
- A stipend to help cover travel-related expenses will be provided
What Will Happen if I Join?
The study will last about 7 months and includes 2 periods:
- Screening Period (up to 30 days): One visit to the study site to complete assessments and determine if you are eligible to participate
- Treatment Period (about 6 months): Up to 6 visits to the study site to monitor your health. You will receive a dose of ZOLADEX 10.8 mg during visits at Week 1 and Week 12
What Is HR+/HER2-Breast Cancer?
Hormone receptor-positive (HR+) is a type of breast cancer in which cancer cells have receptors (proteins) for estrogen (ER-positive), progesterone (PR-positive), or both. These hormones can play a role in the growth of the cancer.
Human epidermal growth factor receptor 2-negative (HER2-) is a type of breast cancer in which cancer cells have no or very low levels of the HER2 protein on their surface. Having too much of the HER2 protein can help cancer cells grow quickly.
The type and stage of breast cancer affect how it behaves and what treatments work best.
The Outlook for HR+/HER2- Breast Cancer Treatment
HR+/HER2– is the most common type of breast cancer, and there have been significant advances in its treatment in recent years. Many of these advances include therapies that target the hormones that can fuel breast cancer cell growth. Your participation in this study would give you access to a treatment that could potentially stop or slow your breast cancer’s growth. And it could help further research in the treatment of breast cancer.
About ZOLADEX
ZOLADEX is an approved medication used worldwide for more than 35 years to treat several conditions, including advanced and metastatic breast cancer. In the United States, ZOLADEX® (goserelin implant) 3.6 mg, given once a month, is approved by the Food and Drug Administration (FDA) to treat advanced HR+ breast cancer. This study is being conducted to see whether a longer-acting formulation, ZOLADEX 10.8 mg, given once every 3 months, works similarly to the monthly 3.6 mg dose and may reduce how often the medicine needs to be given. ZOLADEX 10.8 mg, given once every 3 months, is not approved by the FDA to treat advanced HR+ breast cancer and is therefore considered investigational in this study.
ZOLADEX is a small implant, about the size of a grain of rice, that is injected just under the skin. During the study, you will receive a dose of ZOLADEX 10.8 mg 2 separate times.
Frequently Asked Questions
The Bridging Study is evaluating whether a longer-acting formulation, ZOLADEX 10.8 mg (study drug), given once every 3 months, works similarly to the monthly 3.6 mg dose and may reduce how often the medicine needs to be given.