Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02101385 | Randomized Controlled Trial of Genomically Directed Therapy in Patients With Triple Negative Breast Cancer | PHASE2 | COMPLETED | 193 | — | — | Apr 3, 2014 | Sep 9, 2022 | Sep 28, 2023 | 29 | United States |
Two-year disease-free survival (DFS) in participants with confirmed triple negative breast cancer (TNBC) treated with a genomically directed therapy or standard of care following preoperative chemotherapy. The survival probabilities for arm A and arm B were estimated as 2 year disease free survival. DFS is defined as the duration of time from randomization to time of a DFS event, defined as local failure (invasive), regional failure, distant failure, contralateral breast cancer (invasive or non-invasive), or death from any cause.
| Arm | Type | Description |
|---|---|---|
| Arm A (Genomically Directed Monotherapy) | EXPERIMENTAL | Participants randomized to Experimental Arm A will receive an FDA approved drug at standard dose for four cycles (12-16 weeks total duration, depending on cycle length). Clinical and laboratory monitoring and dose-reductions will follow the FDA package insert guidelines. |
| Control Arm B (Observation/Standard Therapy) | OTHER | Currently no standard therapy has proven efficacy in this patient population and thus observation alone would be considered standard of care. Additional therapy is permitted, however, if deemed appropriate by the treating physician. |
| Name | Type | Description |
|---|---|---|
| Genomically Directed Monotherapy | DRUG | Participants randomized to Experimental Arm A will receive an FDA approved drug at standard dose for four cycles (12-16 weeks total duration, depending on cycle length). The CGTB will assign therapy to each participant individually based on biomarkers/pathways identified by DNA sequencing: |
| Observation/Standard Therapy | OTHER | Currently no standard therapy has proven efficacy in this patient population and thus observation alone would be considered standard of care. Additional therapy is permitted, however, if deemed appropriate by the treating physician. |
Inclusion Criteria: -Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or may be obtained separately. NOTE: Central pathology review may be conducted any time after definitive surgery. Con...