Triple Negative Breast Neoplasms Clinical Trial
Official title:
A Phase Ib/II Study of Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC)
This is a phase Ib/II Study of Leronlimab (PRO 140) combined with Carboplatin in Patients with CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC). Study population will consist of patients with CCR5-positive, locally advanced or metastatic triple-negative breast cancer (mTNBC) who are naïve to chemotherapy in metastatic setting but have been exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings (first-line).
Phase Ib Phase Ib is a dose escalation phase with 3 dose levels (cohorts) of leronlimab (PRO 140) administered in combination with a fixed dose of carboplatin at AUC 5. This dose finding portion of study will follow a "3+3" designed to determine the maximum tolerated dose (MTD) of leronlimab (PRO 140) administered as subcutaneous injection in subjects with histologically confirmed mTNBC that express CCR5. Phase II Phase II is a single arm study with 30 patients in order to test the hypothesis that the combination of carboplatin AUC 5 intravenously and MTD of leronlimab (PRO 140) SC will increase PFS in patients with CCR5 + mTNBC. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04879849 -
A Study of TAK-676 With Pembrolizumab After Radiation Therapy to Treat a Number of Cancers
|
Phase 1 | |
| Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
| Withdrawn |
NCT02427581 -
Safety and Immunogenicity of a Personalized Synthetic Long Peptide Breast Cancer Vaccine Strategy in Patients With Persistent Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy
|
Phase 1 | |
| Not yet recruiting |
NCT05973864 -
Capecitabine Plus Pembrolizumab in Patients With Triple Negative Breast Cancer After Chemo-immunotherapy and Surgery
|
Phase 3 | |
| Completed |
NCT02789332 -
Assessing the Efficacy of Paclitaxel and Olaparib in Comparison to Paclitaxel / Carboplatin Followed by Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy in Patients With HER2-negative Early Breast Cancer and Homologous Recombination Deficiency
|
Phase 2 | |
| Recruiting |
NCT05007106 -
MK-7684A With or Without Other Anticancer Therapies in Participants With Selected Solid Tumors (MK-7684A-005) (KEYVIBE-005)
|
Phase 2 | |
| Recruiting |
NCT05544929 -
A Study of Safety and Efficacy of KFA115 Alone and in Combination With Pembrolizumab in Patients With Select Advanced Cancers
|
Phase 1 | |
| Recruiting |
NCT05208762 -
A Study of SGN-PDL1V in Advanced Solid Tumors
|
Phase 1 | |
| Completed |
NCT01969643 -
A Safety Study of SGN-LIV1A in Breast Cancer Patients
|
Phase 1 | |
| Terminated |
NCT04489940 -
Bintrafusp Alfa in High Mobility Group AT-Hook 2 (HMGA2) Expressing Triple Negative Breast Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT06154109 -
Comparative Efficacy of Xiaopi Granules and Decoction in Triple-negative Breast Cancer: a Randomized Controlled Trial
|
Phase 2 | |
| Withdrawn |
NCT02539017 -
The Clinical Significance of Cellular Immune Adjuvant Therapy of Triple Negative Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT06400472 -
A Study of LY4170156 in Participants With Selected Advanced Solid Tumors
|
Phase 1 | |
| Terminated |
NCT02720185 -
Window of Opportunity Trial of Dasatinib in Operable Triple Negative Breast Cancers With nEGFR
|
Phase 2 | |
| Completed |
NCT03092934 -
A Study of AK-01 (LY3295668) in Solid Tumors
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04895709 -
A Study of BMS-986340 as Monotherapy and in Combination With Nivolumab or Docetaxel in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
| Not yet recruiting |
NCT06380816 -
A Phase I/II Trial of UCB4594 in Participants With Advanced Cancer
|
Phase 1/Phase 2 | |
| Recruiting |
NCT06157892 -
A Study of Disitamab Vedotin Alone or With Other Anticancer Drugs in Solid Tumors
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03036488 -
Study of Pembrolizumab (MK-3475) Plus Chemotherapy vs Placebo Plus Chemotherapy as Neoadjuvant Therapy and Pembrolizumab vs Placebo as Adjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC) (MK-3475-522/KEYNOTE-522)
|
Phase 3 | |
| Recruiting |
NCT06385990 -
Utidelone (UTD1) Plus Capecitabine in Non-pCR TNBC After Neoadjuvant Therapy
|
Phase 2 |