ClinicalTrials.Veeva

Menu

A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR+ and HER2- Locally Advanced, Recurrent or Metastatic Breast Cancer

B

Betta Pharmaceuticals

Status and phase

Active, not recruiting
Phase 3

Conditions

Breast Cancer

Treatments

Drug: placebo
Drug: BPI-16350
Drug: Fulvestrant

Study type

Interventional

Funder types

Industry

Identifiers

NCT05433480
BTP-66732

Details and patient eligibility

About

This is a phase III clinical trial to evaluate the efficacy and safety of BPI-16350 in combination with Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 negative locally advanced,recurrent or metastatic breast cancer with disease progression following endocrine therapy.

Enrollment

274 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Has the pathologically-confirmed diagnosis of locally advanced, recurrent or metastatic, HR positive, HER2 negative Breast Cancer
  • One previous line of chemotherapy for advanced/metastatic disease is allowed
  • Disease Progression following endocrine therapy
  • Have postmenopausal status
  • Have 1 of the following, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: measurable disease or nonmeasurable bone-only disease
  • ECOG: 0~1
  • Adequate organ function

Exclusion criteria

  • Previous treatment with cytotoxic drugs within 4 weeks before enrollment
  • Previous treatment with endocrine or small molecule drug tyrosine kinase inhibitor TKI within 2 weeks before enrollment
  • Patients who received prior treatment with any CDK4/6 inhibitor, everolimus or fulvestant
  • HER2 positive
  • Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, conditions affecting drug swallow and absorption, etc
  • Pregnancy or lactation
  • Other conditions considered not appropriate to participate in this trial by the investigators

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

274 participants in 2 patient groups, including a placebo group

experimental group
Experimental group
Description:
Intervention Drug: BPI-16350, Fulvestrant
Treatment:
Drug: BPI-16350
Drug: Fulvestrant
control group
Placebo Comparator group
Description:
Intervention Drug: Placebo, Fulvestrant
Treatment:
Drug: placebo
Drug: Fulvestrant

Trial contacts and locations

64

Loading...

Central trial contact

Shuseng Wang, Ph.D; Xichun Hu, Ph.D

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems