Status:
RECRUITING
Pembrolizumab + Paclitaxel +/- Bevacizumab for Triple-negative Breast Cancer
Lead Sponsor:
Yukinori Ozaki
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Recurrent Triple-Negative Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
* Breast cancer is histologically divided into non-invasive (approximately 10%) and invasive (approximately 90%), with invasive cancer being the target of chemotherapy. Invasive carcinoma is classifie...
Eligibility Criteria
Inclusion
- Male/female participants who are 18 years of age or older on the day of signing informed consent with histologically or cytologically confirmed diagnosis of invasive breast cancer will be enrolled in this study.
- Participants have been confirmed to be ER negative, HER2 negative according to the latest ASCO/CAP criteria. However, it does not matter whether the result is positive or negative for PgR.
- Participants have been confirmed to be PD-L1 positive in each site's evaluation using biopsy specimen or surgical specimen.
- Participants who have not undergone chemotherapy for recurrent breast cancer. However, prior treatment of Olaparib for metastatic recurrence or unresectable advanced cancer in participants with BRCA gene pathogenic variant is allowed.
- Participants must have recurred after treatment with an anti-PD-1/PD-L1 antibody administered as monotherapy or in combination with other ICIs or chemotherapies as a perioperative drug therapy for triple negative breast cancer.
- Have an Eastern Cooperative Oncology Group performance status of 0 to 1.
Exclusion
- Participants with progressive disease on RECIST or clinically diagnosed during preoperative ICI and chemotherapy.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years prior to enrollment.
- Has known active CNS metastases and/or carcinomatous meningitis.
- Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT06976944
Start Date
July 1 2025
End Date
September 1 2028
Last Update
July 29 2025
Active Locations (15)
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1
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, Japan, 460-0001
2
Nagoya University Hospital
Nagoya, Aichi-ken, Japan, 466-8560
3
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan, 467-8602
4
Akita University Hospital
Akita, Akita, Japan, 010-8543