BridgeMD
Compares treatment options for Breast Cancer
Official title Lenvatinib+Letrozole Versus Fulvestrant in Metastatic ER+/HER2- Breast Cancer, Post Progression on Al + CDK4/6 Inhibitor
ClinicalTrials.gov ID: NCT05181033
What this study is testing
What is Lenvatinib + Letrozole?
Lenvatinib + Letrozole is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for breast cancer.
Also referred to as Lenvima.
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
- Based on the results of the phase Ib/II study, the investigators hypothesize that combining a RET inhibitor lenvatinib with endocrine therapy letrozole improves objective response and progression-free survival compared to fulvestrant alone in the second line setting in patients who have progressed on first line endocrine therapy incorporating a CDK4/6 inhibitor. Letrozole and fulvestrant are anti-hormonal drugs that have been proven to have activity and are considered standard therapies for hormone receptor positive breast cancer.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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 99, women only
You may be able to join if
- Patients may be included in the study only if patient meet all of the following criteria:
- Female, age =\>18 years.
- Histologic or cytologic diagnosis of breast carcinoma.
- Estrogen receptor positive (defined as =\>1% on immunohistochemical staining)
- Progressed on first-line palliative endocrine therapy plus CDK4/6 inhibitor as immediate prior line of endocrine therapy. Prior palliative letrozole...
You likely can't join if
- Patients will be excluded from the study for any of the following reasons:
- HER2 positive tumors.
- Treatment within the last 30 days with any investigational drug.
- Prior therapy with fulvestrant.
- Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
- Major surgery within 28 days of study drug administration.
See the full eligibility criteria
- Patients may be included in the study only if patient meet all of the following criteria:
- Female, age =\>18 years.
- Histologic or cytologic diagnosis of breast carcinoma.
- Estrogen receptor positive (defined as =\>1% on immunohistochemical staining)
- Progressed on first-line palliative endocrine therapy plus CDK4/6 inhibitor as immediate prior line of endocrine therapy. Prior palliative letrozole is allowed.
- Only one prior line of endocrine therapy in the metastatic setting.
- No more than 1 prior line of chemotherapy in the metastatic setting.
- Measurable disease by RECIST criteria.
- ECOG 0-1.
- Estimated life expectancy of at least 12 weeks.
- Adequate organ function including the following: \- Bone marrow: Absolute neutrophil (segmented and bands) count (ANC) =\>1.5 x 109/L Platelets =\>100 x 109/L \- Hepatic: Bilirubin \<= 1.5 x upper limit of normal (ULN)...
- Normal thyroid function on thyroid screen (fT4 and TSH). Patients who have thyroid dysfunction are eligible if thyroid function is optimally controlled.
- Post-menopausal women. Post-menopausal status is defined either by Age =\> 60 years and one year or more of amenorrhea Age \<= 60 years and one year or more of amenorrhea (in the absence of ovarian suppression) and with...
- Signed informed consent from patient or legal representative.
- Patients will be excluded from the study for any of the following reasons:
- HER2 positive tumors.
- Treatment within the last 30 days with any investigational drug.
- Prior therapy with fulvestrant.
- Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
- Major surgery within 28 days of study drug administration.
- Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
- Pregnancy.
- Breast feeding.
- Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
- Non-healing wound.
- Poorly controlled diabetes mellitus.
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- Uncontrolled or symptomatic brain metastases, and/or brain metastases requiring steroids
- History of significant neurological or mental disorder, including seizures or dementia.
- Uncontrolled blood pressure (defined as persistent systolic BP \>140 mmHg or diastolic BP\>90mmHg) in spite of optimized regimen of antihypertensive medication
- Presence of proteinuria defined as 24h urine collection of grade 2 and above (protein \>1.0g/24h)
- Significant cardiovascular impairment: history of congestive heart failure greater that New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or stroke within 6 months of first dose of study...
- Bleeding or thrombotic disorders or gastrointestinal bleeding event or active hemoptysis or use of anticoagulants such as warfarin or similar agents requiring therapeutic INR monitoring, or people at risk of severe...
- Patients with baseline QTc interval \>480ms that persists despite correction of electrolyte abnormalities and/or discontinuation of concomitant medications that are known to prolong QTc interval.
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
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 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. 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.