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A Study of SHR-A1811 and Fulvestrant, With or Without HS-10352, in Locally Advanced or Metastatic Breast Cancer Patients

ConditionsBreast CancerLocally Advanced or Metastatic Breast Cancer
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorHenan Cancer Hospital

About this trial

This study is being conducted to evaluate the efficacy and safety of SHR-A1811 and Fulvestrant in Combination with or without HS-10352 in locally advanced or metastatic breast cancer patients. Subjects will receive SHR-A1811 and Fulvestrant in Combination with or without HS-10352.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged ≥18 years and ≤75 years;

ECOG Performance Status of 0 -2;

Locally advanced/metastatic breast cancer not amenable to curative therapy

Disease progression during treatment or within 12 months of completing adjuvant therapy ;

Disqualifiers

Breast cancer that has not been histologically confirmed;

Inflammatory breast cancer;

Participants ineligible for endocrine therapy due to any disease burden, as judged by the investigator;

Meningeal metastasis or active parenchymal brain metastasis;

Trial design

Design model

Parallel

Treatments tested in this trial

  • SHR-A1811+ Fulvestrant

    Drug

    SHR-A1811 is administered intravenously; fulvestrant is administered Intramuscular

  • SHR-A1811+ Fulvestrant+HS-10352

    Drug

    SHR-A1811 is administered intravenously; fulvestrant is administered Intramuscular ； HS-10351 is administered orally

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: SHR-A1811 + fulvestrant groupExperimental treatment 1 intervention
Group B: HS-10352 groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR) according to RECIST1.1 （SHR-A1811+fulvestrant group and HS-10352 group (Phase II)）

ORR defined as the proportion of patients with the best overall response of complete response or partial response，as determined by the investigator according to RECIST v1.1

Time frame
Up to approximately 4 years
2

Recommended Phase 2 dose (RP2D) (HS-10352 group (Phase Ib))

Time frame
From the first dose to the last dose of the first cycle defined as 28 days

Secondary outcomes

1

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) （SHR-A1811 + fulvestrant group and HS-10352 group (Phase II)）

Evaluate the incidence and severity of adverse events according to CTCAE 5.0

Time frame
Up to approximately 4 years
2

Objective Response Rate (ORR) according to RECIST1.1 （HS-10352 group(Phase Ib)）

ORR defined as the proportion of patients with the best overall response of complete response or partial response，as determined by the investigator according to RECIST v1.1

Time frame
Up to approximately 4 years
3

Progression-Free Survival (PFS)（SHR-A1811 +fulvestrant group and HS-10352 group (Phase Ib/Phase II)）

PFS is defined as the time from the first therapeutic dose to death or disease progression

Time frame
Up to 4 years
4

Overall Survival (OS) （SHR-A1811 +fulvestrant group and HS-10352 group (Phase Ib/Phase II)）

OS is defined as the time from the first therapeutic dose to death from any cause

Time frame
Up to 4 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Henan Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

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