LDE225 in Treating Patients With Stage II-III Estrogen Receptor- and HER2-Negative Breast Cancer
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|ClinicalTrials.gov Identifier: NCT01757327|
Recruitment Status : Withdrawn (Poor accrual)
First Posted : December 28, 2012
Last Update Posted : April 27, 2015
|Condition or disease||Intervention/treatment||Phase|
|Breast Neoplasms||Drug: Erismodegib Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Placebo-Controlled Phase II Trial Evaluating the Effect of Hedgehog Inhibitor LDE225 on Bone Marrow Disseminated Tumor Cells in Women With Early Stage Estrogen Receptor Negative and HER2 Negative Breast Cancer|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2019|
Experimental: Arm I (erismodegib [LDE225])
400 mg daily and treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO daily and treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.
Other Name: PLCB
- Proportion of patients who are bone marrow DTC-negative after therapy [ Time Frame: at 6 months ]Comparing LDE225 to placebo using a stratified Cochran-Mantel-Haenszel test for difference of proportions
- Disease-free survival (DFS) [ Time Frame: 2 years from initiation of study treatment ]Defined as duration after surgery that the patient survives without signs or symptoms of cancer; analyzed using a stratified Cox proportional hazards model.
- Overall Survival (OS) [ Time Frame: 2 years from initiation of study treatment ]Defined as time from date of diagnosis to death of any cause or to last follow-up; analyzed using a stratified Cox proportional hazards model.
- Ptch1 expression after treatment with LDE225 or placebo [ Time Frame: At 6 months ]Stratified, repeated measures ANOVA will be used to compare Ptch1 expression in the two treatment arms
- Incidence of toxicities associated with LDE225 or placebo treatment [ Time Frame: For 30 days following the last day of study treatment; up to 25 months ]Toxicities described and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.0.
- Time to recurrence and death in DTC-negative patients and DTC-positive patients [ Time Frame: 2 years from initiation of study treatment ]Cox regression will be used to compare time to recurrence or death in DTC-negative patients ineligible for randomization with those randomized to receive treatment
- Time to recurrence and death in ICC negative versus ICC positive patients [ Time Frame: 2 years from initiation of treatment ]95% confidence intervals using Cox proportional hazard regression
- Concordance of DTC determination by ICC or gene expression [ Time Frame: Baseline ]Expressed using kappa statistics with 95% confidence intervals. McNemar's test will be used to test for a statistically significant difference between the proportion positive by ICC and gene expression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01757327
|Principal Investigator:||Cynthia Ma, M.D., Ph.D.||Washington University School of Medicine|
|Principal Investigator:||Rebecca Aft, M.D., Ph.D.||Washington University School of Medicine|