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NSAI+ CDK4/6i · 1 trial · 1 indication
To evaluate progression-free survival (PFS) in participants with HR-positive and HER2 negative unresectable or metastatic breast cancer with detectable circulating tumor DNA (ctDNA) at baseline who do not achieve molecular response but show no evidence of progression per RECIST 1.1 after three cycles of standard of care (SOC) treatment with non-steroidal aromatase inhibitor (NSAI) + CDK4/6 inhibitor in Arms 2 and 3. PFS will be evaluated separately in participants randomized to NSAI + CDK4/6 inhibitor + capivasertib (Arm 2) and fulvestrant + CDK4/6 inhibitor + capivasertib (Arm 3) and compared to historical control.
| Arm | Type | Description |
|---|---|---|
| Cohort A, Arm 1 | ACTIVE_COMPARATOR | Continue NSAI + CDK4/6i |
| Cohort A, Arm 2 | EXPERIMENTAL | NSAI + CDK4/6i + Capivasertib |
| Cohort A, Arm 3 | EXPERIMENTAL | Fulvestrant + CDK4/6i + Capivasertib |
| Cohort B, Arm 1 | ACTIVE_COMPARATOR | Continue NSAI + CDK4/6i |
| Name | Type | Description |
|---|---|---|
| NSAI + CDK4/6i | DRUG | NSAI: Dosed per standard practice, Days 1-28 of every cycle; CDK4/6 Inhibitor (Palbociclib or Ribociclib): Dosed per standard practice, Days 1-21 of every cycle x 4 cycles |
| NSAI + CDK4/6i + Capivasertib | DRUG | NSAI: Dosed per standard practice, Days 1-28 of every cycle; CDK4/6 Inhibitor (Palbociclib or Ribociclib): Dosed per standard practice, Days 1-21 of every cycle x 4 cycles; Capivasertib: Dosed 4 days on and 3 days off weekly, every cycle |
| Fulvestrant + CDK4/6i + Capivasertib | DRUG | NSAI: Dosed per standard practice, Days 1-28 of every cycle; CDK4/6 Inhibitor (Palbociclib or Ribociclib): Dosed per standard practice, Days 1-21 of every cycle x 4 cycles Capivasertib: Dosed 4 days on and 3 days off weekly, every cycle Fulvestrant: Dosed days 1 and 15 of Cycle 1 and Day 1 of Cycles 2+ |
| Guardant Reveal | DIAGNOSTIC_TEST | ctDNA Assay |
Registration Step 1 Inclusion Criteria: * Participants must have histologically or cytologically confirmed adenocarcinoma of the breast with unresectable or metastatic disease. * Participants must have evidence of either 1) measurable disease with or without non-measurable disease, or 2) non-measur...
NSAI+ CDK4/6i is an investigational combination therapy being studied for the treatment of HR positive, HER2 negative breast cancer. It is currently in Phase 3 clinical development, with an active trial enrolling patients to evaluate its efficacy in this patient population.
NSAI+ CDK4/6i is being developed by Guardant Health, Inc., a company publicly traded under the ticker symbol GH. The company is conducting a Phase 3 clinical trial to evaluate this combination therapy in HR positive, HER2 negative breast cancer.
NSAI+ CDK4/6i is currently in Phase 3 clinical development. It is an investigational therapy, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is actively enrolling patients with HR positive, HER2 negative breast cancer.
NSAI+ CDK4/6i is being evaluated in a Phase 3 clinical trial registered as NCT07802626. This trial, titled 'Adding Capivasertib to Standard Treatment in HR Positive, HER2 Negative Metastatic Breast Cancer Based on ctDNA Testing,' is not yet recruiting and aims to enroll 1084 participants.
Yes, NSAI+ CDK4/6i is the same as NSAI + CDK4/6i. These names refer to the same investigational combination therapy being developed by Guardant Health for HR positive, HER2 negative breast cancer. The ongoing Phase 3 trial is NCT07802626.