Active — Not RecruitingPhase 1

A Study of SH3765 Tablets in Combination With Fulvestrant in Patients With HR+/HER2- Advanced Breast Cancer.

China30 participantsStarted 2025-09-30

Plain-language summary

Evaluate the efficacy and safety of the SH3765 tablet combined with fulvestrant in the treatment of patients with advanced HR-positive breast cancer

Age range18 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≥18 years, female.
✓. Histologically confirmed HR-positive, HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) advanced breast cancer.
✓. Clear clinical or radiological evidence of disease progression or intolerance prior to enrollment.
✓. The patient has received one prior endocrine therapy regimen (as monotherapy or in combination, e.g., with a CDK4/6 inhibitor), and;a)has radiological evidence of breast cancer recurrence or progression during or within 12 months after completion of (neo)adjuvant endocrine therapy; or b) has radiological evidence of progression while receiving prior endocrine therapy as a line of treatment for locally advanced or metastatic breast cancer.
✓. The patient must meet at least one of the following definitions:
✓. At least one measurable lesion according to RECIST version 1.1 (measurable as defined in Appendix 1; target lesions cannot be from the brain). If the subject has only one measurable lesion at baseline, that lesion must not have been previously irradiated, or there must be evidence of clear progression of the lesion after completion of radiotherapy.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
✓. Life expectancy ≥12 weeks.

Number of Participants With Dose Limiting Toxicities (DLTs)

Timeframe: Days 1-28

Maximum tolerated dose (MTD)

Timeframe: Days 1-28

NCT IDNCT07557004

SponsorNanjing Sanhome Pharmaceutical, Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-06-30

Who can participate

Age range18 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≥18 years, female.
✓. Histologically confirmed HR-positive, HER2-negative (IHC 0, IHC 1+, or IHC 2+/ISH-) advanced breast cancer.
✓. Clear clinical or radiological evidence of disease progression or intolerance prior to enrollment.
✓. The patient has received one prior endocrine therapy regimen (as monotherapy or in combination, e.g., with a CDK4/6 inhibitor), and;a)has radiological evidence of breast cancer recurrence or progression during or within 12 months after completion of (neo)adjuvant endocrine therapy; or b) has radiological evidence of progression while receiving prior endocrine therapy as a line of treatment for locally advanced or metastatic breast cancer.
✓. The patient must meet at least one of the following definitions:
✓. At least one measurable lesion according to RECIST version 1.1 (measurable as defined in Appendix 1; target lesions cannot be from the brain). If the subject has only one measurable lesion at baseline, that lesion must not have been previously irradiated, or there must be evidence of clear progression of the lesion after completion of radiotherapy.
✓. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
✓. Life expectancy ≥12 weeks.