A Trial to Evaluate Sacituzumab Govitecan in Combination With Endocrine Therapy in Patients With HR-positive, HER2-negative Metastatic Breast Cancer Progressed on CDK4/6 Inhibitors

NCT07163481 | Not Yet Recruiting Phase 1

• 1 other identifier: IN-CN-979-6924
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

SoGreat is an open-label, single-arm, modular, two-stage, Phase Ib/II study. SoGreat (Part 1) is an open-label, modular, Phase Ib study.

Conditions

Stage IV (Metastatic) Breast Cancer

Keywords

Sacituzumab Govitecan; Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  assessed by the incidence, nature, and severity of adverse events (AEs; NCI CTCAE v5.0)

  through study completion, an average of 1 year

Secondary Outcomes (6)

• ORR

  up to 16 weeks

• DoR

  From date of treatment initiation until the date of first documented progression, assessed up to 24 months

• DCR

  up to 24 weeks

• PFS

  From date of treatment initiation until the date of first documented progression or death from any cause, assessed up to 24 months

• OS

  From date of treatment initiation until the date of death from any cause, assessed up to 60 months

Study Arms (2)

Module 1: Progressed on Aromatase Inhibitors Combined with CDK4/6 Inhibitors

EXPERIMENTAL

Patients Progressed on Aromatase Inhibitors Combined with CDK4/6 Inhibitors Intervention: Sacituzumab Govitecan 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles Combined with Fulvestrant 500 mg intramuscularly into the buttock on Day 1 of 28-day cycles and Cycle 1 Day 15

Drug: Sacituzumab Govitecan + Fulvestrant

Module 2: Progressed on Selective Estrogen Receptor Degrader Combined with CDK4/6 Inhibitors

EXPERIMENTAL

Patients Progressed on Selective Estrogen Receptor Degrader Combined with CDK4/6 Inhibitors Intervention: Sacituzumab Govitecan 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles Combined with one of the two Investigator's choice of aromatase inhibitors (ICAI), orally, once daily: * Anastrozole 1 mg, or * Exemestane 25 mg

Drug: Sacituzumab Govitecan + Anastrozole / Exemestane

Interventions

Sacituzumab Govitecan + Fulvestrant DRUG

Sacituzumab Govitecan 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles Combined with Fulvestrant 500 mg intramuscularly into the buttock on Day 1 of 28-day cycles and Cycle 1 Day 15

Module 1: Progressed on Aromatase Inhibitors Combined with CDK4/6 Inhibitors

Sacituzumab Govitecan + Anastrozole / Exemestane DRUG

Sacituzumab Govitecan 10 mg/kg intravenously on Days 1 and 8 of 21-day cycles Combined with One of the Two Investigator's choice of aromatase inhibitors (ICAI), orally, once daily: Anastrozole 1 mg Exemestane 25 mg

Module 2: Progressed on Selective Estrogen Receptor Degrader Combined with CDK4/6 Inhibitors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male patients, 18 years of age or older, able to understand and give written informed consent.
• ECOG performance status of 0 or 1.
• Men, pre-menopausal or perimenopausal women must use gonadotropin-releasing hormone agonists (such as goserelin) in a standardized manner.
• Postmenopausal women must meet one of the following criteria:
• bilateral oophorectomy.
• age 60 years or older.
• age \<60 years and natural menopause (not induced by medication) for more than 12 months with follicle-stimulating hormone (FSH) and estradiol levels in the postmenopausal range.
• Histologically documented breast cancer that:
• Is locally advanced inoperable or metastatic recurrence.
• Is documented as HR-positive, HER2-negative (either ER and/or PgR positive \[ER or PgR 1%\]; HER2 negative \[IHC 2+/ISH-; IHC1+/ISH- or untested; IHC 0/ISH- or untested\]) per ASCO/CAP guidelines in the metastatic setting. If a patient has had multiple ER/PgR/HER2 results after metastatic disease, the most recent test result will be used to confirm eligibility.
• Radiologic or objective evidence of disease progression on or after the last systemic therapy prior to starting study treatment.
• Must have had disease progression on CDK4/6i combined with endocrine therapy administrated as the first line and the only therapy for metastatic disease. The time till progression (TTP) for the first line CDK4/6 must be no less than 6 months.
• Patients who received adjuvant endocrine therapy with or without CDK4/6i with curative intent for early breast cancer are eligible, as long as they relapse after the first 24 months of adjuvant endocrine therapy.
• No prior chemotherapy for advanced or metastatic breast cancer. Patients who have received chemotherapy in the neo-adjuvant or adjuvant setting are eligible, as long as they have had a disease-free interval (defined as completion of systemic chemotherapy to the diagnosis of advanced or metastatic disease) of \>12 months.
• Measurable disease by CT or MRI in accordance with RECIST v 1.1, the bone-only disease was not measurable and was not permitted.

You may not qualify if:

• Positive serum pregnancy test or women who are breastfeeding.
• Women of childbearing potential or fertile men unwilling to use highly effective contraception during the study and up to 6 months after treatment discontinuation in women of childbearing potential and 3 months in males post last IP administration.
• Known hypersensitivity to the study drug, its metabolites, or formulation excipient.
• Requirement for ongoing therapy with or prior use of any prohibited medications listed in Section 4.2.6.
• Have had a prior anticancer biologic agent within 4 weeks prior to enrollment or have had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to enrollment and have not recovered (i.e., ≥ Grade 2 is considered not recovered) from AEs at the time of study entry.
• Have not recovered (i.e., ≥ Grade 2 is considered not recovered) from AEs due to a previously administered agent.
• Note: patients with any grade neuropathy or alopecia are an exception to this criterion and will qualify for the study.
• Note: if patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• Have previously received treatment with topoisomerase I inhibitors as a free form or as other formulations.
• Have previously received treatment in advanced or metastatic setting with systemic therapy before or after the first line CDK4/6i combined with ET, including but not limited to:
• chemotherapy.
• endocrine monotherapy or combined with target therapy (PI3Ki, mTORi, AKTi, HDACi, etc.).
• PARPi.
• immune checkpoint inhibitors (PD-1, PD-L1, CTLA-4, etc.)
• antibody-drug conjugates.

Sponsors & Collaborators

• Hunan Cancer Hospital: lead
• Gilead Sciences: collaborator

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410000, China

Location

MeSH Terms

Conditions

Neoplasm Metastasis; Breast Neoplasms

Interventions

sacituzumab govitecan; Fulvestrant; Anastrozole; exemestane

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Qu Chang Ouyang, Professor

CONTACT

13973135318; ouyangquchang@hnca.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: September 9, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

CN (1)