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New treatment option for Metastatic Breast Cancer
Official title A Phase Ib/II Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+/HER2- BC
ClinicalTrials.gov ID: NCT07002177
What this study is testing
What is FWD1802?
FWD1802 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for metastatic breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- people consent to provide blood samples for centralized laboratory testing of ESR1 mutation status and other biomarkers.
- Histologically or cytologically confirmed ER-positive/HER2-negative locally advanced or metastatic breast cancer
- people must meet at least one of the following criteria: postmenopausal or prior bilateral oophorectomy, or postmenopausal or...
- Prior Therapy Requirements:people must meet all of the following criteria:
- Progression during/after, intolerance to, ineligibility for, or refusal of standard therapy
You likely can't join if
- Leptomeningeal metastasis (carcinomatous meningitis)；Spinal cord compression；Symptomatic or clinically unstable central nervous system (CNS)...
- History or any persistent chronic gastrointestinal disorders or other conditions of impaired absorption that may interfere with oral absorption of...
- Symptomatic visceral metastases , or clinically symptomatic and unstable effusions;Pleural effusion;Ascites;Pericardial effusion or Pulmonary...
- Prior therapy with any selective estrogen receptor degrader (SERD) or similar agents other than fulvestrant
- Inadequate washout period for prior anticancer therapies.
- Type 1 diabetes mellitus; Type 2 diabetes mellitus with poor glycemic control at screening(applies only to the everolimus combination arm).
See the full eligibility criteria
- people consent to provide blood samples for centralized laboratory testing of ESR1 mutation status and other biomarkers.
- Histologically or cytologically confirmed ER-positive/HER2-negative locally advanced or metastatic breast cancer
- people must meet at least one of the following criteria: postmenopausal or prior bilateral oophorectomy, or postmenopausal or Premenopausal/perimenopausal women must agree to receive and maintain approved luteinizing...
- Prior Therapy Requirements:people must meet all of the following criteria:
- Progression during/after, intolerance to, ineligibility for, or refusal of standard therapy
- Endocrine therapy history: Recurrence during or within 1 year after completing ≥2 years of adjuvant endocrine therapy;OR progression after ≥1 line of endocrine therapy for advanced breast cancer(ABC) with ≥6 months of...
- ≤2 prior lines of chemotherapy for ABC
- No prior SERD (selective estrogen receptor degrader) therapy except fulvestrant
- Everolimus combination arm: Prior CDK4/6 inhibitor therapy requiredf) CDK4/6 inhibitor combination arm:Permitted ≤1 line of prior non-investigational CDK4/6 inhibitor therapy;If only received adjuvant CDK4/6 inhibitor...
- Phase Ib: At least one evaluable lesion per RECIST v1.1, allowed people with osteolytic bone lesion(s) confirmed by CT/MRI.Phase II: At least one measurable lesion per RECIST v1.1. Subject must have sufficient organ and...
- Leptomeningeal metastasis (carcinomatous meningitis)；Spinal cord compression；Symptomatic or clinically unstable central nervous system (CNS) metastases；
- History or any persistent chronic gastrointestinal disorders or other conditions of impaired absorption that may interfere with oral absorption of the investigational drug
- Symptomatic visceral metastases , or clinically symptomatic and unstable effusions;Pleural effusion;Ascites;Pericardial effusion or Pulmonary lymphangitis carcinomatosa. Prior intracavitary infusion therapy should have...
- Prior therapy with any selective estrogen receptor degrader (SERD) or similar agents other than fulvestrant
- Inadequate washout period for prior anticancer therapies.
- Type 1 diabetes mellitus; Type 2 diabetes mellitus with poor glycemic control at screening(applies only to the everolimus combination arm).
- people will be excluded if they meet any of the following:
- Interstitial lung disease or drug-induced ILD history, OR evidence of active pneumonitis on chest CT scan within 4 weeks prior to first study treatment.
- Severe pulmonary disease at screening, including but not limited to:Severe asthma;Severe chronic obstructive pulmonary disease (COPD) Idiopathic
- Uncontrolled hypertension despite antihypertensive therapy, defined as:Systolic blood pressure (SBP) \>150 mmHg OR Diastolic blood pressure (DBP) \>95 mmHg.
- Active cardiac disease or history of cardiac dysfunction
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.