MedTrace Logo

A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC

NCT07002177 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2026-01-07

No results posted yet for this study

Summary

This is a Study to Evaluate the Efficacy and Safety of Multiple Combination Therapies with FWD1802 in Subjects with ER-positive/HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer

Conditions

  • Metastatic Breast Cancer
  • Breast Cancer Stage I
  • Breast Cancer Stage II
  • Locally Advanced Breast Cancer (LABC)
  • ER+ Breast Cancer

Interventions

DRUG

FWD1802

orally QD with 28 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons

DRUG

Palbociclib 125mg

Dose: 125 mg Route: Orally Frequency: Once daily (QD) Schedule: Administered for 21 consecutive days, followed by a 7-day treatment break (3-weeks-on/1-week-off), constituting a 28-day cycle

DRUG

Ribociclib 200Mg Oral Tablet

Dose: 600 mg Route: Orally Frequency: Once daily (QD) Schedule: Administered for 21 consecutive days, followed by a 7-day treatment break, constituting a 28-day cycle

DRUG

Abemaciclib 150 MG

Dose: 150 mg Route: Orally Frequency: BID Schedule: Everyday

DRUG

Everolimus 10 mg

Dose: 10 mg Route: Orally Frequency: QD Schedule: Everyday

Sponsors & Collaborators

  • Forward Pharmaceuticals Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2028-05-01
Completion
2028-11-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07002177 on ClinicalTrials.gov