Actively Recruiting
A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
Led by Forward Pharmaceuticals Co., Ltd. · Updated on 2026-01-07
196
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide consent for blood samples to test for ESR1 mutation status and other biomarkers
- Diagnosed with ER-positive/HER2-negative locally advanced or metastatic breast cancer confirmed by tissue analysis
- Be postmenopausal, have had prior bilateral oophorectomy, or agree to receive and maintain LHRH agonist therapy if premenopausal or perimenopausal
- Have disease progression during or after, intolerance to, ineligibility for, or refusal of standard therapy
- Have recurrence during or within 1 year after completing 2 or more years of adjuvant endocrine therapy, or progression after at least 1 line of endocrine therapy for advanced breast cancer with 6 months of maintenance therapy
- Have had 2 or fewer prior lines of chemotherapy for advanced breast cancer
- Have no prior treatment with selective estrogen receptor degrader therapy except fulvestrant
- For the Everolimus combination arm: prior CDK4/6 inhibitor therapy required
- For the CDK4/6 inhibitor combination arm: permitted 1 or fewer prior lines of non-investigational CDK4/6 inhibitor therapy; if only adjuvant CDK4/6 inhibitor therapy received, recurrence must occur more than 12 months after completion
- Have at least one evaluable lesion per RECIST v1.1 for Phase Ib or at least one measurable lesion for Phase II
- Have adequate organ and bone marrow function at screening
You will not qualify if you...
- Leptomeningeal metastasis, spinal cord compression, or symptomatic/unstable central nervous system metastases
- Chronic gastrointestinal disorders or conditions impairing oral drug absorption
- Symptomatic visceral metastases or clinically unstable effusions such as pleural effusion, ascites, pericardial effusion, or pulmonary lymphangitis carcinomatosa
- Prior treatment with any selective estrogen receptor degrader except fulvestrant
- Inadequate washout period from prior anticancer therapies
- Type 1 diabetes or poorly controlled type 2 diabetes at screening (for Everolimus arm only)
- History or evidence of interstitial lung disease or active pneumonitis within 4 weeks before treatment
- Severe pulmonary diseases including severe asthma or severe chronic obstructive pulmonary disease
- Uncontrolled hypertension despite treatment (systolic >150 mmHg or diastolic >95 mmHg)
- Active cardiac disease or history of cardiac dysfunction
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center, Shanghai
Shanghai, China
Actively Recruiting
Research Team
J
Jinglin Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here