18 and older, any sex, with Metastatic Triple Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Overall Response Rate (ORR) in Patients Treated With CNPPrimary· Up to 24 months
The number of people with tumor responses according to RECIST (V1.1). These responses include Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on stu
Complete Response (CR)
Group
Value
95% CI
Carboplatin + Nab-paclitaxel + Pembrolizumab
2
Partial Response (PR)
Group
Value
95% CI
Carboplatin + Nab-paclitaxel + Pembrolizumab
11
Progressive Disease (PD)
Group
Value
95% CI
Carboplatin + Nab-paclitaxel + Pembrolizumab
6
Stable Disease (SD)
Group
Value
95% CI
Carboplatin + Nab-paclitaxel + Pembrolizumab
8
Progression-free Survival (PFS) in Patients Treated With CNPSecondary· Up to 24 months
Average time (in months) patient's tumors did not progress according to the RECIST criteria (V1.1). Progressive disease is defined as Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm
Group
Value
95% CI
Carboplatin + Nab-paclitaxel + Pembrolizumab
5.8
4.7 – 8.5
Disease Control Rate (DCR) in Patients Treated With CNPSecondary· Up to 24 months
the percentage of patients with advanced or metastatic cancer who have achieved complete response, partial response and stable disease to a therapeutic intervention. Responses are defined as Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify
Group
Value
95% CI
Carboplatin + Nab-paclitaxel + Pembrolizumab
21
Duration of Response in Patients Treated With CNPSecondary· Up to 24 months
Average time patients have a response, as defined by the RECIST criteria (V1.1). Response includes: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm or Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Complete
Group
Value
95% CI
Carboplatin + Nab-paclitaxel + Pembrolizumab
NA
NA – NA
Partial
Group
Value
95% CI
Carboplatin + Nab-paclitaxel + Pembrolizumab
6.3
3 – 7
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to five years after cycle six of treatment.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Carboplatin + Nab-paclitaxel + Pembrolizumab
Serious: 13/30 (43%)
Deaths: 27/30
Serious adverse events (25 terms)
Reaction
System
Carboplatin + Nab-paclitax…
Dyspnea
Respiratory, thoracic and mediastinal disorders
—
Fever
General disorders
—
Alanine aminotransferase increased
Investigations
—
Lung infection (pneumonia)
Infections and infestations
—
Pneumonitis
Respiratory, thoracic and mediastinal disorders
—
Anemia
Blood and lymphatic system disorders
—
Nausea
Gastrointestinal disorders
—
Severe Left Thigh Pain Due to a Hematoma
Musculoskeletal and connective tissue disorders
—
Creatinine increased
Investigations
—
Acute kidney injury
Renal and urinary disorders
—
Breast infection
Infections and infestations
—
INR increased
Blood and lymphatic system disorders
—
Autoimmune disorder-hepatitis
Immune system disorders
—
Urinary tract infection
Infections and infestations
—
Back pain
Musculoskeletal and connective tissue disorders
—
Chest wall pain
Musculoskeletal and connective tissue disorders
—
Pleuritic pain
Respiratory, thoracic and mediastinal disorders
—
Device related infection
Infections and infestations
—
Soft tissue infection
Infections and infestations
—
Death due to disease progression
General disorders
—
Non-cardiac chest pain
General disorders
—
Psychosis-altered mental status
Psychiatric disorders
—
Infection
Infections and infestations
—
Allergic reaction
Immune system disorders
—
Generalized pain-hip and lower extremities
Musculoskeletal and connective tissue disorders
—
Other adverse events (144 terms — click to expand)
The purpose of this study is to see how effective the combination of the two chemotherapy drugs (carboplatin and nab-paclitaxel) are when added to a third drug, pembrolizumab.
Pembrolizumab is an investigational (experimental) drug that works by reinvigorating the immune system, allowing it to target and destroy cancer cells. Pembrolizumab is experimental because it is not approved by the Food and Drug Administration (FDA) for this type of breast cancer treatment.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04832438 — 9-ING-41 Plus Carboplatin in Patients With Advanced, Metastatic Salivary Gland Carcinoma
· Phase 2
· withdrawn
NCT07229339 — Zipalertinib With Carboplatin and Pemetrexed for the Treatment of Resectable, Stage II-IIIB, Non-Small Cell Lung Cancer
· Phase 2
· not yet recruiting
NCT07346196 — A Trial of Locoregionally Advanced Squamous Cell Carcinoma of The Head and Neck
· Phase 2
· not yet recruiting
NCT07441681 — Comparing Radiation Plus Cetuximab to Radiation Plus Chemotherapy in People With Head and Neck Cancer Who Cannot Receive
· Phase 3
· not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa
· Phase 2
· recruiting
Other recruiting trials for Metastatic Triple Negative Breast Cancer
Currently open trials in the same condition.
NCT03330847 — To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy.
· Phase 2
· active not recruiting
Other Case Comprehensive Cancer Center trials
Trials by the same sponsor.
NCT06811454 — Mindfulness-based Intervention for Depressive Symptoms Sent Via Text (MINDSET)
· NA
· not yet recruiting
NCT07167056 — Artificial Intelligence-Powered Support For Quality Of Life Improvement In Participants With Cancer
· NA
· recruiting
NCT07084779 — Investigation of Impact of AI on Prostate Cancer Workflow
· NA
· recruiting
NCT06904482 — Co-Transplant of an Unmodified Haplo-Identical Graft With Cord Blood
· Phase 2
· recruiting
NCT07044362 — Histotripsy Plus Chemotherapy vs Chemotherapy Alone for Advanced Colorectal Liver Metastasis
· NA
· recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Case Comprehensive Cancer Center
Last refreshed: 6 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03121352.