OncoMatch/Clinical Trials/NCT05256225
Testing the Addition of Herceptin Hylecta or Phesgo to the Usual Chemotherapy for HER2 Positive Endometrial Serous Carcinoma or Carcinosarcoma
Is NCT05256225 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Carboplatin and Hyaluronidase-zzxf/Pertuzumab/Trastuzumab for endometrial carcinoma.
Treatment: Carboplatin · Hyaluronidase-zzxf/Pertuzumab/Trastuzumab · Paclitaxel · Trastuzumab/Hyaluronidase-oysk — This phase III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin Hylecta \[TM\]) or pertuzumab, trastuzumab and hyaluronidase-zzxf (Phesgo \[TM\]) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial cancer. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab or pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Hyaluronidase is an endoglycosidase. It helps to keep pertuzumab and trastuzumab in the body longer, so that these medications will have a greater effect. Hyaluronidase also allows trastuzumab and trastuzumab/pertuzumab to be given by injection under the skin and shortens their administration time compared to trastuzumab or pertuzumab alone. Paclitaxel is a taxane and in a class of medications called antimicrotubule agents. It stops tumor cells from growing and dividing and may kill them. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Giving Herceptin Hylecta or Phesgo in combination with paclitaxel and carboplatin may shrink the tumor and prevent the cancer from coming back in patients with HER2 positive endometrial cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Endometrial Cancer
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+)
HER2 positive as defined by ASCO/CAP 2018 Breast Cancer guidelines. In general HER2 positivity is defined as any of the following: 3+ immunohistochemistry (IHC)
Required: HER2 (ERBB2) overexpression with amplification (IHC 2+ with positive ISH)
2+ IHC with positive in situ hybridization (ISH)
Required: HER2 (ERBB2) amplification
NGS demonstrates HER2 (ERBB2) amplification
Excluded: MLH1 loss
Endometrial cancers that are mismatch repair deficient (dMMR) by IHC are not eligible
Excluded: MSH2 loss
Endometrial cancers that are mismatch repair deficient (dMMR) by IHC are not eligible
Excluded: MSH6 loss
Endometrial cancers that are mismatch repair deficient (dMMR) by IHC are not eligible
Excluded: PMS2 loss
Endometrial cancers that are mismatch repair deficient (dMMR) by IHC are not eligible
Disease stage
Required: Stage IA, IB, II, IIIA, IIIB, IIIC1, IIIC2, IVA, IVB (FIGO 2009)
FIGO 2009 stage IA-IVB, non-recurrent
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: chemotherapy
Patients must NOT have received prior chemotherapy...for treatment of endometrial carcinoma
Cannot have received: biologic therapy
Patients must NOT have received prior...biologic therapy...for treatment of endometrial carcinoma
Cannot have received: targeted therapy
Patients must NOT have received prior...targeted therapy for treatment of endometrial carcinoma
Cannot have received: radiation therapy
Exception: Vaginal brachytherapy for treatment of endometrial cancer is permitted during study treatment. Planned use of vaginal brachytherapy must be declared at time of registration
Patients must NOT have received prior radiation therapy for treatment of endometrial carcinoma. Prior radiation includes external beam pelvic radiation therapy, external beam extended field pelvic/para-aortic radiation therapy, and/or intravaginal brachytherapy
Lab requirements
Blood counts
Platelets >= 100,000/mcl; ANC >= 1,500/mcl (within 14 days prior to registration)
Kidney function
Creatinine <= 1.5 x ULN or eGFR >= 50 mL/min (within 14 days prior to registration)
Liver function
Total serum bilirubin <= 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level <= 3 x ULN may be enrolled); AST and ALT <= 3 x ULN (within 14 days prior to registration)
Platelets >= 100,000/mcl (within 14 days prior to registration); ANC >= 1,500/mcl (within 14 days prior to registration); Creatinine <= 1.5 x ULN or eGFR >= 50 mL/min (within 14 days prior to registration); Total serum bilirubin level <= 1.5 x ULN (patients with known Gilbert's disease who have bilirubin level <= 3 x ULN may be enrolled) (within 14 days prior to registration); AST and ALT <= 3 x ULN (within 14 days prior to registration)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
- Alaska Women's Cancer Care · Anchorage, Alaska
- Banner University Medical Center - Tucson · Tucson, Arizona
- University of Arizona Cancer Center-North Campus · Tucson, Arizona
- University of Arkansas for Medical Sciences · Little Rock, Arkansas
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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