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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

ConditionStage IV (Metastatic) Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorHunan Cancer Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

bilateral oophorectomy.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Module 1: Progressed on Aromatase Inhibitors Combined with CDK4/6 InhibitorsExperimental treatment 1 intervention
Group B: Module 2: Progressed on Selective Estrogen Receptor Degrader Combined with CDK4/6 InhibitorsExperimental treatment 1 intervention

Trial outcomes

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)

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

ORR

Objective Response Rate: Proportion of patients with a predefined tumor size reduction (Complete Response + Partial Response

Time frame
up to 16 weeks
2

DoR

Duration of Response: Time from first response (CR/PR) to disease progression or death

Time frame
From date of treatment initiation until the date of first documented progression, assessed up to 24 months
3

DCR

Disease Control Rate: Proportion of patients achieving CR, PR, or Stable Disease (SD)

Time frame
up to 24 weeks
4

PFS

Progression-Free Survival: Time from treatment initiation to disease progression or death

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hunan Cancer Hospital

Lead sponsor

Gilead Sciences

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: