This phase II/III trial investigates if adding HerceptinHylecta™ (trastuzumab and hyaluronidase-oysk) or Phesgo™ (pertuzumab,trastuzumab, and hyaluronidase-zzxf) to standard chemotherapy (paclitaxel andcarboplatin) can help shrink tumors in patients with HER2 positive endometrialserous carcinoma or carcinosarcoma.
NCT05256225
Herceptin Hylecta™ (trastuzumab and hyaluronidase-oysk)
Phesgo™(pertuzumab, trastuzumab, and hyaluronidase-zzxf)
standardchemotherapy (paclitaxel and carboplatin)
· Trastuzumab and pertuzumab aretypes of targeted therapy that block growth signals from reaching cancer cellsby attaching to HER2 receptors on their surface.
· Hyaluronidase helps these drugsstay in the body longer and allows for quicker, under-the-skin injections.
· Paclitaxel and carboplatin arechemotherapy drugs that kill or stop cancer cells from dividing.
· This combination couldpotentially reduce tumor size and prevent cancer recurrence.
Phase II: To test how effective the combination of HERCEPTIN HYLECTA (trastuzumab and hyaluronidase-oysk) and PHESGO (pertuzumab, trastuzumab, and hyaluronidase-zzxf) with paclitaxel and carboplatin is in treating patients with HER2 positive endometrial serous carcinoma or carcinosarcoma.
Phase III: To further evaluate the effectiveness of the same treatment combination in a larger group of patients with the same conditions.
This clinical study is for patients who have a type of uterine cancer that has not been treated with chemotherapy before. Here's what patients need to know to participate:
Cancer Type: The study is open to patients with HER2-positive endometrial serous carcinoma or carcinosarcoma.
Cancer Stage: Patients with any stage from the earliest (stage IA) to the most advanced (stage IVB) can join, provided their cancer has not come back after initial treatment.
Surgery Requirements: Patients must have had surgery for their cancer within the last 8 weeks. If they didn’t have a hysterectomy, a biopsy confirming cancer is required.
Disease Measurement: The study includes patients whether their disease can be measured by scans or not. For those with measurable disease, specific criteria based on scan results are used to define it.
Eligibility Criteria:
Participants will also need to provide a consent form before joining the study.
For this clinical study, there are certain conditions that would prevent someone from participating:
Prior Cancer Treatment: You cannot join if you've had chemotherapy, biological therapy, or targeted therapy for endometrial cancer before. Also, you shouldn’t have had radiation therapy for endometrial cancer, except for vaginal brachytherapy, which is allowed during the study.
Hormonal Therapy: If you’ve received hormonal therapy for endometrial cancer, you must stop it at least one week before joining the study.
Upcoming Surgeries or Radiation: You cannot plan to have major surgery (like a hysterectomy) or external beam radiation therapy until the cancer shows signs of progression after joining the study.
Heart Conditions: You can't join if you have uncontrolled high blood pressure, recent heart attacks or severe heart disease, or serious heart rhythm problems.
Lung Conditions: If you have severe lung disease, including difficulty breathing at rest, severe pneumonitis, or other serious lung conditions, you cannot participate.
Other Health Issues: Uncontrolled infections, severe congestive heart failure, or any serious mental health or social situations that could affect your ability to follow the study rules are also reasons you might not be able to join.
Medications: If you’ve been treated with certain strong medications that affect liver enzymes within two weeks before joining the study, you may need to wait longer.
Nursing Women: If you are nursing and unwilling to stop, you cannot participate in the study.
This is NOT a complete list of sites. Please refer to the clinical trial webpage for the complete, updated sites.
Alabama Locations
Arizona Locations
Arkansas Locations
California Locations
Irvine, CA 92618
Long Beach, CA 90813
Los Angeles, CA 90027
Modesto, CA 95355
Mountain View, CA 94040
Riverside, CA 92505
Roseville, CA 95661
Sacramento, CA 95817
San Francisco, CA 94115
Sunnyvale, CA 94086
Upland, CA 91786
Walnut Creek, CA 94598
Colorado Locations
Denver, CO 80206
Greeley, CO 80631
Highlands Ranch, CO 80129
Loveland, CO 80539
Connecticut Locations
Delaware Locations
District of Columbia Locations
Florida Locations
Georgia Locations
Hawaii Locations
Idaho Locations
Fruitland, ID 83619
Meridian, ID 83642
Nampa, ID 83686
Nampa, ID 83687
Post Falls, ID 83854
Sandpoint, ID 83864
Twin Falls, ID 83301
Illinois Locations
Chicago, IL 60612
Chicago, IL 60637
Danville, IL 61832
Decatur, IL 62526
DeKalb, IL 60115
Effingham, IL 62401
Evanston, IL 60201
Geneva, IL 60134
Glenview, IL 60026
Highland Park, IL 60035
Hinsdale, IL 60521
Lake Forest, IL 60045
Mattoon, IL 61938
New Lenox, IL 60451
O'Fallon, IL 62269
Orland Park, IL 60462
Springfield, IL 62702
Urbana, IL 61801
Warrenville, IL 60555
Yorkville, IL 60560
Indiana Locations
Crown Point, IN 46307
Dyer, IN 46311
Goshen, IN 46526
Hobart, IN 46342
Indianapolis, IN 46202
Indianapolis, IN 46237
Indianapolis, IN 46260
Indianapolis, IN 46312
Lafayette, IN 47905
Mooresville, IN 46158
Munster, IN 46321
South Bend, IN 46601
Valparaiso, IN 46383
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