Clinical Trial Title Phase 2 Study of Alpelisib and Fulvestrant for PIK3CA-mutated Estrogen Receptor (ER)-positive Endometrioid Endometrial Cancers
Trial Status Open to Enrollment
Start Date 02/28/2024
Location hospitals
Trial Type Cancer - Adult Oncology
Specific Condition Endometrioid Endometrial Cancers
Description This is a 2 stage multi-center study designed to evaluate the efficacy of the combination of alpelisib and fulvestrant in patients with PIK3CA-mutated ER-positive endometrioid endometrial cancers by estimating the objective response rate (ORR). Treatment will continue until either unacceptable toxicity, progression of disease, or investigator/patient request for withdrawal.
Eligibility Criteria

Eligible Patients

  • Patient must have advanced (FIGO 2014 Stage III or IV), persistent, or recurrent endometrial carcinoma, which is not likely to be curable by surgery or radiotherapy.
  • Patients must have endometrioid histology (all grades allowed) based on hysterectomy or biopsy specimen and have positive expression of ER and oncogenic PIK3CA mutation.
  • Prior chemotherapy in the adjuvant setting for Stage I, II, or III is permitted. Prior chemoradiotherapy for a pelvic recurrence is permitted.
  • Regardless of circumstances, no more than one prior systemic chemotherapy regimen (excluding cisplatin or carboplatin administered as a radiosensitizing agent in combination with radiotherapy) is permitted, and no more than one additional systemic therapy is permitted.

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number Central IRB
Notes Study Details | A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer | ClinicalTrials.gov
Principal Investigator Julia Fehniger, MD
Contact Name Oncology Clinical Research
Contact Phone 503-413-8199
Contact Fax 503-413-6920
Contact E-Mail oncologyresearch@lhs.org