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Genomically Directed Monotherapy · 1 trial · 2 indications
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...
Genomically Directed Monotherapy is an investigational small molecule being studied for the treatment of malignant neoplasm of breast, specifically in patients with triple negative breast cancer. It is a biomarker-selected therapy, meaning it is designed for patients whose tumors have specific genomic characteristics identified through testing.
Genomically Directed Monotherapy is being developed by Vera Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol VERA. The company is conducting clinical research to evaluate this investigational therapy in the oncology setting.
Genomically Directed Monotherapy is in Phase 2 clinical development. It has completed one Phase 2 trial, and it remains an investigational drug that has not been approved by regulatory authorities. The completed trial enrolled 193 participants with triple negative breast cancer.
Genomically Directed Monotherapy has been evaluated in one completed clinical trial, registered as NCT02101385. This was a randomized controlled Phase 2 trial titled 'Randomized Controlled Trial of Genomically Directed Therapy in Patients With Triple Negative Breast Cancer,' which enrolled 193 participants in the United States.
Genomically Directed Monotherapy is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial, but it remains in clinical development. The completed trial was a randomized controlled study in patients with triple negative breast cancer, and further studies would be needed before any regulatory approval could be considered.