Not Yet RecruitingPhase 1

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

United States88 participantsStarted 2026-04-29

Plain-language summary

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

Age range18 Years – 55 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age and gender:
✓. 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.
✓. HER2-: Via American Society of Clinical Oncology, College of American Pathology (ASCO-CAP) guidelines.
✓. Prior treatment:
✓. Participants may have received prior radiotherapy.

✕. Postmenopausal: Naturally or surgically postmenopausal (regardless of age).
✕. Body mass index (BMI): \<18 kg/m\^2 or \>35.0 kg/m\^2.
✕. Prior surgical or radiation procedures: History of bilateral oophorectomy or prior radiotherapy to the ovaries.
✕. Recent radiotherapy:
✕. Radiotherapy for breast cancer within 4 weeks prior to trial enrollment.
✕. All radiotherapy-related toxicities (except alopecia) must have recovered to CTCAE v6.0 ≤Grade 1 before trial enrollment.
✕. Radiotherapy during trial: Planned radiotherapy during trial period.
✕. Selective estrogen receptor modulator (SERM) use during trial: Participants may not receive tamoxifen or other SERMs during the trial and must discontinue any SERMs prior to enrollment, other endocrine therapies (eg, aromatase inhibitor, fulvestrant, or other FDA-approved SERDs) are allowed.

Percentage of Participants with LH Values Below a Specified Threshold at Week 6

Timeframe: Week 6

NCT IDNCT07310420

SponsorTerSera Therapeutics LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-11-30

Who can participate

Age range18 Years – 55 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age and gender:
✓. 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.
✓. HER2-: Via American Society of Clinical Oncology, College of American Pathology (ASCO-CAP) guidelines.
✓. Prior treatment:
✓. Participants may have received prior radiotherapy.

✕. Postmenopausal: Naturally or surgically postmenopausal (regardless of age).
✕. Body mass index (BMI): \<18 kg/m\^2 or \>35.0 kg/m\^2.
✕. Prior surgical or radiation procedures: History of bilateral oophorectomy or prior radiotherapy to the ovaries.
✕. Recent radiotherapy:
✕. Radiotherapy for breast cancer within 4 weeks prior to trial enrollment.
✕. All radiotherapy-related toxicities (except alopecia) must have recovered to CTCAE v6.0 ≤Grade 1 before trial enrollment.
✕. Radiotherapy during trial: Planned radiotherapy during trial period.
✕. Selective estrogen receptor modulator (SERM) use during trial: Participants may not receive tamoxifen or other SERMs during the trial and must discontinue any SERMs prior to enrollment, other endocrine therapies (eg, aromatase inhibitor, fulvestrant, or other FDA-approved SERDs) are allowed.