Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Taselisib · 1 trial · 1 indication
Objective response rate (ORR) was defined as proportion of participants achieving complete response (CR) or partial response (PR). As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes ( i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition).
ORR was defined as proportion of participants achieving CR or PR. As per modified RECIST v1.1, CR: disappearance of all target lesions, PR: at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Total pCR was assessed by local pathology review on samples taken at surgery following completion of neoadjuvant therapy. tpCR was defined as the absence of any residual invasive cancer on hematoxylin and eosin evaluation of the resected breast specimen and all sampled ipsilateral lymph nodes (i.e., ypT0/Tis, ypN0 in the AJCC staging system, 7th edition).
| Arm | Type | Description |
|---|---|---|
| Letrozole + Placebo | PLACEBO_COMPARATOR | Participants will receive 2.5 mg letrozole tablets orally QD along with placebo on a 5-days-on/2-days-off schedule for a total of 16 weeks. |
| Letrozole + Taselisib | EXPERIMENTAL | Participants will receive 2.5 milligrams (mg) letrozole tablets orally once daily (QD) along with taselisib tablets at 4 mg (two 2 mg tablets) orally on a 5 days-on/2 days-off schedule for a total of 16 weeks. |
| Name | Type | Description |
|---|---|---|
| Letrozole | DRUG | Letrozole tablets will be administered orally at 2.5 mg QD for 16 weeks. |
| Placebo | OTHER | Placebo tablets matched to taselisib formulation will be administered orally daily on 5 days-on/2 days-off schedule for up to 16 weeks. |
| Taselisib | DRUG | Taselisib will be administered orally at 4 mg (two 2 mg tablets) daily. |
Inclusion Criteria: * Female participants * Postmenopausal status * Histologically confirmed invasive breast carcinoma, with all of the following characteristics: (i) Primary tumor greater than or equal to (\>/=) 2 centimeters (cm) in largest diameter (cT1-3) by MRI; (ii) Stage I to operable Stage ...
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Taselisib is an investigational small molecule being studied for the treatment of breast cancer. It is being evaluated in post-menopausal women with breast cancer as a neoadjuvant therapy, meaning it is given before surgery. The drug is being tested in combination with letrozole, an aromatase inhibitor, to assess its efficacy and safety in this patient population.
Taselisib is a small molecule that targets the PI3K pathway, specifically inhibiting the phosphatidylinositol 3-kinase (PI3K) enzyme. By blocking this pathway, Taselisib aims to interfere with cancer cell growth and survival. This mechanism is being investigated in the context of hormone receptor-positive breast cancer, where PI3K signaling is often dysregulated.
Taselisib is being developed by Roche Holding AG, a multinational healthcare company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in breast cancer. Roche's ticker symbol is RHHBY on the OTC market.
Taselisib is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The drug is currently being studied in a Phase 2 trial for breast cancer, and its safety and efficacy have not yet been established for commercial use.
Taselisib has been studied in one completed Phase 2 clinical trial with the identifier NCT02273973. This trial, known as LORELEI, evaluated neoadjuvant letrozole plus Taselisib versus letrozole plus placebo in post-menopausal women with breast cancer. The trial enrolled 334 participants and was conducted across multiple countries.
Taselisib is not known to have any alternative names. It is a distinct investigational compound developed by Roche. In clinical trials, it is referred to by its generic name, Taselisib, and is being studied specifically for its potential role in treating breast cancer.