Evaluating ovarian suppression using the long-acting ZOLADEX® (goserelin implant) 10.8 mg formulation.
The Bridging Study is seeking investigators to participate in a clinical study for premenopausal women with HR+/HER2 - advanced breast cancer
About the Bridging Study
The Bridging Study is a Phase 1, single-arm, open-label clinical study to evaluate ovarian suppression following subcutaneous administration of ZOLADEX 10.8 mg. All participants will receive 2 doses of ZOLADEX 10.8 mg, given 12 weeks apart. The study duration is about 7 months, including 7 visits to the study site.
Key Eligibility Criteria
- Females aged 18 to 55
- Advanced or metastatic HR+/HER2- breast cancer not amenable to surgical resection or radiation with curative intent
- Participants aged 18 to 40 (inclusive) must be of premenopausal status, defined as:
- Regular history of menses OR
- E2 >30 pg/mL AND FSH <40 IU/L
- Participants aged >40 and ≤55 years must be of premenopausal status, defined as:
- E2 >30 pg/mL AND
- FSH <40 IU/L AND
- Regular history of menses
- Participants aged 18 to 40 (inclusive) must be of premenopausal status, defined as:
- Cannot have a history of bilateral oophorectomy or prior radiotherapy to the ovaries
- Cannot receive tamoxifen or other selective estrogen receptor modulators (SERMs) during the clinical study
E2=estradiol; FSH=follicle-stimulating hormone; GnRH=gonadotropin-releasing hormone; HER2-=human epidermal growth factor receptor 2-negative; HR+=hormone receptor-positive.
Why Become a Site
By participating in the Bridging Study, you will contribute to research evaluating the long-acting ZOLADEX 10.8 mg formulation in premenopausal patients with HR+/HER2- advanced breast cancer.
Established therapy:
ZOLADEX (goserelin implant) 10.8 mg is an FDA-approved therapy in several indications and has an established clinical profile.
Operational simplicity:
A straightforward study design featuring minimally invasive, short-duration procedures is intended to facilitate ease of implementation.
Strong sponsor partnership:
Sites will receive dedicated support, including training, recruitment materials, and regulatory assistance, ensuring a smooth study experience.
Recognition and collaboration:
Participating sites may be acknowledged for their contributions to advancing care in hormone receptor-positive advanced breast cancer, with potential opportunities for professional visibility and collaboration.
About ZOLADEX 10.8 mg
ZOLADEX is a well-established gonadotropin-releasing hormone (GnRH) agonist used to suppress ovarian estrogen production and is approved in the United States in both the monthly formulation (ZOLADEX 3.6 mg) and the 12-week formulation (ZOLADEX 10.8 mg). The long-acting 10.8 mg dose offers comparable efficacy to monthly dosing with reduced clinic visits. Recent international approvals support its growing role in breast cancer care.
About TerSera
TerSera Therapeutics LLC is a biopharmaceutical company with a focus in oncology, rare diseases, and non-opioid pain management. Founded in 2016, TerSera is building new cornerstones of care through its portfolio of unique therapeutics, amplifying its ability to deliver meaningful outcomes for patients. For more information, visit https://tersera.com/.