Study of Immunotherapy in Combination With Chemotherapy in HER2-negative Inflammatory Breast Cancer (NCT03515798) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study of Immunotherapy in Combination With Chemotherapy in HER2-negative Inflammatory Breast Cancer
France52 participantsStarted 2018-08-29
Plain-language summary
This phase II multicentre randomized open-label study will assess the safety and efficacy of Pembrolizumab in combination with standard chemotherapy in inflammatory breast cancer. Pembrolizumab will be administered every 3 weeks during the neoadjuvant chemotherapy. Tissue and blood samples will be collected pre- and post-treatment for translational research.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male/female participants who are at least 18 years of age on the day of signing informed consent
✓. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 Evaluation of ECOG is to be performed within 7 days prior to the date of randomization. Note: may consider ECOG PS 2 if good rationale provided and discussed with Sponsor team.
✓. Able to comply with the protocol,
✓. Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen, or any other regimen of social security
✓. Patient (or legally acceptable representative if applicable) has provided written informed consent for the trial,
✓. Previously untreated, histologically confirmed diagnosis of breast cancer and confirmed inflammatory breast cancer defined as follows:
✓. HER2 negative tumors by immunohistochemistry (IHC 0 or 1+) or fluorescent/chromogenic in situ hybridization (FISH- or CISH-)
✓. Hormone receptors status known,
Exclusion criteria
✕. Has metastatic breast cancer,
✕. Has HER2-positive breast cancer,
✕. Has bilateral breast cancer
✕. Prior allogeneic stem cell or solid organ transplantation
What they're measuring
1
Central evaluation of pathological complete response rate
Timeframe: Following completion of neoadjuvant systemic treatment, an average of 24 weeks
2
Dose Limiting Toxicity (DLT) rates
Timeframe: during 21 days following the first administration of pembrolizumab
✕. A WOCBP who has a positive serum pregnancy test within 72 hours prior to randomiza-tion
✕. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment, Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
✕. Has known active CNS disease or carcinomatous meningitis.
✕. Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug,