Phase 2
N=61
Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in Uterine Serous Cancer
Endometrial Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01367002 ↗Enrolled (actual)
61
Serious AEs
33.3%
Results posted
Apr 2023
Primary outcome: Primary: Progression Free Survival Differences Between Treatment Arms. — 8.049; 12.945 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Carboplatin/Paclitaxel (Drug); Trastuzumab (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Yale University
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival Differences Between Treatment Arms. |
8.049; 12.945 | — |
| SECONDARY To Assess the Safety Profile of Trastuzumab in USPC Patients by CTCAE v4.0 |
6; 14; 28; 32 | — |
| SECONDARY To Assess Objective Response Rate (ORR) |
2; 1; 4; 3; 1; 5 | — |
| SECONDARY To Assess Overall Survival (OS) |
7; 9 | — |
Summary
The primary objective of this study is to estimate whether the addition of trastuzumab to paclitaxel and carboplatin chemotherapy improves progression free survival when compared to paclitaxel and carboplatin alone in Uterine Serous Papillary Carcinoma (USPC) patients overexpressing Her2/neu at 3+ level by immunohistochemistry (IHC)or positive by fluorescence in situ hybridization (FISH).
Eligibility Criteria
Inclusion Criteria
- Patients must have advanced (stage III-IV) or recurrent histologically confirmed USPC with measurable disease.
- Patients must harbor a tumor HER2/neu+ based upon IHC staining score of 3+ or 2+ with confirmed gene amplification by FISH
Exclusion Criteria
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancers, significant history of cardiac disease, uncontrolled hypertension, unstable medical issue, brain leptomeningeal, prior therapy with trastuzumab, uncontrolled seizure disorder, seropositive for HIV, active hepatitis, hemorrhagic diathesis or requiring supplemental oxygen.
Data sourced from ClinicalTrials.gov (NCT01367002). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.