A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer (NCT05154487)

🧪 Interventions in This Study

• Alpelisib Pill (DRUG)
• Fulvestrant injection (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. 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. Histologic confirmation of recurrent disease is required. For cases of persistent disease, histologic confirmation of the primary disease with radiologic evidence of progression is required.
2. Patients must have endometrioid histology (all grades allowed) based on hysterectomy or biopsy specimen and have positive expression of ER and oncogenic PIK3CA mutation per criteria below. a. PIK3CA mutations considered oncogenic or likely oncogenic. i. Oncogenic/likely oncogenic PIK3CA mutations identified on tests performed by the labs listed on https://ecog-acrin.org/nci-match-eay131-designated-labs will be considered confirmed for the purposes of this study. ii. Oncogenic/likely oncogenic PIK3CA mutations identified by other tests will need to be confirmed by the study prior to enrollment. b. Estrogen receptor (ER) status will be considered positive if ≥1% of tumor cells demonstrate positive nuclear staining by immunohistochemistry. Pathology report documenting ER status must be provided at enrollment. Sites are required to report results of previous MMR and/or MSI status testing in the EDC if available.
3. All patients must have measurable disease. Measurable disease is defined by RECIST version 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be greater than or equal to 10mm when measured by CT, MRI or caliper measurement by clinical exam; or greater than or equal to 20mm when measured by chest x-ray. Lymph nodes must be greater than or equal to 15mm in short axis when measured by CT or MRI. Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST 1.1. Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
4. Prior chemotherapy in the adjuvant setting for Stage I, II, or III or metastatic/recurrent/Stage IV is permitted. Prior chemoradiotherapy for a pelvic recurrence is permitted. Prior immunotherapy and/or targeted therapy is allowed in addition to, in combination with, in lieu of, or subsequent to prior chemotherapy. Prior hormone therapy (progesterone, tamoxifen, aromatase inhibitor) is allowed and not considered a prior line of therapy. Prior treatment with fulvestrant not allowed. There are no limits on the number of prior lines of chemotherapy. Patients who received prior chemotherapy must have recovered (Common Terminology Criteria for Adverse Events \[CTCAE\] Grade less than or equal to 1) from the acute effects of chemotherapy except for residual alopecia or Grade 2 peripheral neuropathy prior to enrollment. A washout period of at least 21 days is required between last chemotherapy dose and initiation of therapy. Patients who received radiotherapy must have completed and fully recovered from the acute effects of radiotherapy. A washout period of at least 14 days is required between end of radiotherapy and initiation of therapy.
5. Patient must be able to swallow oral medications.
6. Patient must have an ECOG performance status of 0 to 2.
7. Patients must have adequate glucose control as defined by the following (both criteria must be met):
8. Fasting blood glucose (FBG) ≤140/dL (7.7mmol/L) AND
9. Hemoglobin A1c (HbA1c) ≤6.4%
10. Patients must have adequate organ and marrow function as defined below NOTE: Institutional/laboratory upper limit of normal = ULN Institutional/laboratory lower limit of normal = LLN Bone marrow function:
11. Absolute neutrophil count (ANC) greater than or equal to 1000/mcl
12. Platelets greater than or equal to 100,000 cells/mcl

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (21 Sites)

• City of Hope — Duarte, California
• Mount Sinai Medical Center — Miami Beach, Florida
• AdventHealth Gynecologic Oncology — Orlando, Florida
• Tampa General Hospital — Tampa, Florida
• Moffit Cancer Center at International Plaza — Tampa, Florida
• Moffitt Cancer Center — Tampa, Florida
• Moffit Cancer Center at Wesley Chapel — Wesley Chapel, Florida
• Endeavor Health — Evanston, Illinois
• Endeavor Health Clinical Operations, Glenbrook Hospital — Glenview, Illinois
• Endeavor Health Clinical Operations, Highland Park Hospital — Highland Park, Illinois
• Ascension St. Vincent — Indianapolis, Indiana
• Norton Cancer Institute — Louisville, Kentucky
• Johns Hopkins Medicine — Baltimore, Maryland
• Northwell Health Cancer Institute — Lake Success, New York
• QCC- Northwell Health Physicians Partners Medical — Rego Park, New York
• Kettering Health Cancer Center — Kettering, Ohio
• Oklahoma Cancer Specialists and Research Institute, LLC — Tulsa, Oklahoma
• Legacy Good Samaritan Medical Center — Portland, Oregon
• Legacy Meridian Park Medical Center — Tualatin, Oregon
• Legacy Salmon Creek Medical Center — Vancouver, Washington
• University of Wisconsin Clinical Science Center — Madison, Wisconsin

📞 Contact the Study Coordinator

Phone: (800) 826-4673

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
• 💵 Compensation indicated: Patients must have adequate organ and marrow function as defined below NOTE: Institutional/laboratory upper limit of normal = ULN Institutional/laboratory lower limit of normal = LLN Bone marro...

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.