A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With HR+, HER2- Advanced Breast Cancer

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-55
SponsorTerSera Therapeutics LLC

About this trial

The primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH).

Eligibility criteria

Qualifiers

Gonadotropin-releasing Hormone (GnRH) treatment-naïve: Female participants aged 18 to 55 years, inclusive.

GnRH treatment-exposed <6 months: Female participants aged 18 to 55 years, inclusive, if GnRH treatment started within <6 months of signing the informed consent.

Advanced or metastatic breast cancer: Histological confirmation of breast cancer with evidence of locally advanced or metastatic disease, which is not amenable to surgical resection or radiation therapy with curative intent per investigator's assessment.

HR+: Either estrogen receptor positive (ER+) or progesterone receptor positive (PR+) breast cancer, defined as 1% to 100% of tumor nuclei are positive for ER or PR via immunohistochemistry.

Disqualifiers

Postmenopausal: Naturally or surgically postmenopausal (regardless of age).

Body mass index (BMI): <18 kg/m² or >35.0 kg/m².

Prior surgical or radiation procedures: History of bilateral oophorectomy or prior radiotherapy to the ovaries.

Radiotherapy for breast cancer within 4 weeks prior to trial enrollment.

Trial design

Treatments tested in this trial

  • ZOLADEX

Treatment groups

88 Participants
are divided into 1 treatment group

Sponsors and collaborators