Bortezomib Followed by Pembrolizumab and Cisplatin in metTNBC
NCT04265872 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2026-02-12
Summary
The hypothesis of this pilot trial is that administration of bortezomib will inhibit NHEJ in metastatic TNBC leading at the time of disease progression to metastases that are HR-deficient and sensitive to pembrolizumab and cisplatin therapy. The trial will include in depth analysis of the patients' TNBC genome and phosphoproteome to evaluate HR-proficiency and deficiency, and nuclear proteins that drive NHEJ, before and upon progression with bortezomib therapy.
Conditions
Interventions
- DRUG
-
Bortezomib; pembrolizumab and cisplatin injections--bortezomib followed by pembro/cis
injection into a vein
Sponsors & Collaborators
-
Baylor Research Institute
lead OTHER
Principal Investigators
-
Joyce O'Shaughnessy, MD · Texas Oncology
Study Design
- Allocation
- NA
- Purpose
- HEALTH_SERVICES_RESEARCH
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-15
- Primary Completion
- 2026-12-31
- Completion
- 2027-03-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
A Study of Neoadjuvant Paclitaxel in Combination With Bavituximab in Early- Stage Triple- Negative Breast Cancer
NCT02685306 ·Status: WITHDRAWN ·Phase: PHASE2
-
PET Dynamics to Response-Adapted Neoadjuvant Therapy in TNBC
NCT06245889 ·Status: RECRUITING ·Phase: PHASE2
-
A Clinical Trial Assessing Safety and Efficacy of BZL101 for Metastatic Breast Cancer
NCT00907959 ·Status: UNKNOWN ·Phase: PHASE2
-
Evaluation of Survival in Patients With Metastatic Breast Cancer Receiving High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation
NCT02860585 ·Status: COMPLETED
-
Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advanced Triple Negative Breast Cancer
NCT06434064 ·Status: RECRUITING ·Phase: PHASE2
-
Ipatasertib in Combination With Carboplatin, Carboplatin/Paclitaxel, or Capecitabine/Atezolizumab in Treating Patients With Metastatic Triple Negative Breast Cancer
NCT03853707 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Phase II Study of Nivolumab in Combination With Cabozantinib for Metastatic Triple-negative Breast Cancer
NCT03316586 ·Status: COMPLETED ·Phase: PHASE2
-
Pembrolizumab and Binimetinib in Treating Patients With Locally Advanced or Metastatic Triple Negative Breast Cancer
NCT03106415 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Testing the Addition of an Individualized Vaccine to Durvalumab and Tremelimumab and Chemotherapy in Patients With Metastatic Triple Negative Breast Cancer
NCT03606967 ·Status: RECRUITING ·Phase: PHASE2
-
Paclitaxel, Trastuzumab, and Pertuzumab in the Treatment of Metastatic HER2-Positive Breast Cancer
NCT01276041 ·Status: COMPLETED ·Phase: PHASE2
-
Standard of Care Chemotherapy Plus Pembrolizumab for Breast Cancer
NCT02734290 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of Trastuzumab Emtansine, Paclitaxel, and Pertuzumab in Patients With HER2-Positive, Locally Advanced or Metastatic Breast Cancer
NCT00951665 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
A Study of Pembrolizumab and Cryoablation in People With Breast Cancer
NCT06246968 ·Status: RECRUITING ·Phase: PHASE1
-
A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer
NCT03742102 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
High Dose Radiation Therapy With Pembrolizumab and Chemotherapy for the Treatment of Patients With PD-L1 Positive Metastatic Triple Negative Breast Cancer
NCT06492759 ·Status: RECRUITING ·Phase: PHASE2
-
Neoadjuvant Nivolumab and Chemotherapy in Patients With Localized Triple-negative Breast Cancer
NCT04331067 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
Neratinib in Combination With Ruxolitinib in Patients With mTNBC
NCT06008275 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
Dinaciclib and Epirubicin Hydrochloride in Treating Patients With Metastatic Triple-Negative Breast Cancer
NCT01624441 ·Status: COMPLETED ·Phase: PHASE1
-
Temsirolimus in Treating Patients With Locally Advanced or Metastatic Breast Cancer
NCT00376688 ·Status: COMPLETED ·Phase: PHASE2
-
Neoadjuvant Platinum-based Chemoradiation Therapy for Locally Advanced Triple Negative Breast Cancer
NCT01167192 ·Status: TERMINATED ·Phase: PHASE2
-
Gemcitabine and Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer
NCT00005991 ·Status: COMPLETED ·Phase: PHASE2
-
Brostallicin and Cisplatin in Treating Patients With Metastatic Breast Cancer
NCT01091454 ·Status: COMPLETED ·Phase: PHASE2
-
Carboplatin and Nab-Paclitaxel With or Without Vorinostat in Treating Women With Newly Diagnosed Operable Breast Cancer
NCT00616967 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Platinum for Triple-Negative Metastatic Breast Cancer and Evaluation of p63/p73 as a Biomarker of Response
NCT00483223 ·Status: COMPLETED ·Phase: PHASE2
-
A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors
NCT02162719 ·Status: COMPLETED ·Phase: PHASE2