Clinical trial · Interventional
Study Of PF-04691502 (PI3K/mTOR Inhibitor) In Combination With Exemestane Compared With Exemestane Alone In Patients With Advanced Breast Cancer
An Open-Label Randomized Phase 2 Study Of PF-04691502 (PI3K/mTOR Inhibitor) In Combination With Exemestane Compared With Exemestane Alone In Patients With Estrogen Receptor Positive, Her-2 Negative Advanced Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
PF-04691502 is an inhibitor of PI3K and mTOR kinase. Exemestane is an aromatase inhibitor for the treatment of advanced breast cancer in women whose disease has progressed following tamoxifen therapy. The combination of PF-04691502 and exemestane might mitigate resistance to hormonal therapy and result in greater clinical benefit than exemestane alone in women with estrogen receptor positive advanced breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exemestane | Drug | Exemestane | ALIAS |
| PF-04691502 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PF-04691502 + Exemestane
- description
- PF-04691502 in combination with Exemestane
- interventionNames
- Drug: PF-04691502
- Drug: Exemestane
- type
- ACTIVE_COMPARATOR
- label
- Exemestane
- description
- Exemestane alone
- interventionNames
- Drug: Exemestane
Primary outcomes (1)
- measure
- Progression-Free Survival
- timeFrame
- Baseline up to month 12
Secondary outcomes (13)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Inoperable estrogen receptor positive, Her-2 negative advanced breast cancer * Previously treated with an aromatase inhibitor * Primary or secondary hormone resistance * Acceptable glucose control, bone marrow, liver and kidney function Exclusion Criteria: * Inflammatory breast carcinoma * Prior therapy with an agent active on PI3K, Akt, and/or mTOR * Known hypersensitivity to exemestane * Significant gastrointestinal abnormalities which may impair intake, transit, or absorption of the study drugs * Current or anticipated need for food or drugs that are known inhibitors or inducers of CYP3A4
References
Publications (0)
Data not yet available