Trial Outcomes & Findings for Cemiplimab in High-risk or Locally Advanced Luminal and Triple Negative Breast Cancer (NCT NCT04243616)
NCT ID: NCT04243616
Last Updated: 2026-07-27
Results Overview
This is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
27 weeks from start of treatment
Results posted on
2026-07-27
Participant Flow
Participant milestones
| Measure |
Drug Treatment
Cemiplimab, Paclitaxel, Carboplatin (not mandatory), Doxorubicin, Cyclophosphamide
Cemiplimab: 350 mg, IV, Day 1 of Cycle 1-2 (3-week cycle)
Paclitaxel: 80 mg/m\^2, IV, Day 1,8 and 15 of Cycles 1-4 (3-week cycle)
Carboplatin (not mandatory): Area under curve (AUC)=6, IV, Day 1 of Cycles 1-4 of Paclitaxel cycles (3-week cycle)
Doxorubicin: 60 g/m\^2, IV, Day 1 of Cycles 1-4 of ddAC (2-week cycle)
Cyclophosphamide: 600 g/m\^2, IV, Day 1 of Cycles 1-4 of dose-dense Adriamycin (Doxorubicin) and Cyclophosphamide (ddAC) (2-week cycle)
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
33
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cemiplimab in High-risk or Locally Advanced Luminal and Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Drug Treatment
n=36 Participants
Cemiplimab, Paclitaxel, Carboplatin (not mandatory), Doxorubicin, Cyclophosphamide
Cemiplimab: 350 mg, IV, Day 1 of Cycle 1-2 (3-week cycle)
Paclitaxel: 80 mg/m\^2, IV, Day 1,8 and 15 of Cycles 1-4 (3-week cycle)
Carboplatin (not mandatory): Area under curve (AUC)=6, IV, Day 1 of Cycles 1-4 of Paclitaxel cycles (3-week cycle)
Doxorubicin: 60 g/m\^2, IV, Day 1 of Cycles 1-4 of ddAC (2-week cycle)
Cyclophosphamide: 600 g/m\^2, IV, Day 1 of Cycles 1-4 of dose-dense Adriamycin (Doxorubicin) and Cyclophosphamide (ddAC) (2-week cycle)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
32 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: 27 weeks from start of treatmentThis is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy.
Outcome measures
| Measure |
Drug Treatment
n=33 Participants
Cemiplimab, Paclitaxel, Carboplatin (not mandatory), Doxorubicin, Cyclophosphamide
Cemiplimab: 350 mg, IV, Day 1 of Cycle 1-2 (3-week cycle)
Paclitaxel: 80 mg/m\^2, IV, Day 1,8 and 15 of Cycles 1-4 (3-week cycle)
Carboplatin (not mandatory): Area under curve (AUC)=6, IV, Day 1 of Cycles 1-4 of Paclitaxel cycles (3-week cycle)
Doxorubicin: 60 g/m\^2, IV, Day 1 of Cycles 1-4 of ddAC (2-week cycle)
Cyclophosphamide: 600 g/m\^2, IV, Day 1 of Cycles 1-4 of dose-dense Adriamycin (Doxorubicin) and Cyclophosphamide (ddAC) (2-week cycle)
|
|---|---|
|
The Proportion of Breast Cancer Patients With Pathological Complete Response (pCR).
pCR
|
24.2 percentage of subjects
|
|
The Proportion of Breast Cancer Patients With Pathological Complete Response (pCR).
Not pCR
|
75.8 percentage of subjects
|
Adverse Events
Drug Treatment
Serious events: 14 serious events
Other events: 30 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Drug Treatment
n=36 participants at risk
Cemiplimab, Paclitaxel, Carboplatin (not mandatory), Doxorubicin, Cyclophosphamide
Cemiplimab: 350 mg, IV, Day 1 of Cycle 1-2 (3-week cycle)
Paclitaxel: 80 mg/m\^2, IV, Day 1,8 and 15 of Cycles 1-4 (3-week cycle)
Carboplatin (not mandatory): Area under curve (AUC)=6, IV, Day 1 of Cycles 1-4 of Paclitaxel cycles (3-week cycle)
Doxorubicin: 60 g/m\^2, IV, Day 1 of Cycles 1-4 of ddAC (2-week cycle)
Cyclophosphamide: 600 g/m\^2, IV, Day 1 of Cycles 1-4 of dose-dense Adriamycin (Doxorubicin) and Cyclophosphamide (ddAC) (2-week cycle)
|
|---|---|
|
General disorders
Pain
|
5.6%
2/36 • Number of events 2 • Up to 7 months.
|
|
Infections and infestations
Skin infection
|
5.6%
2/36 • Number of events 2 • Up to 7 months.
|
|
Nervous system disorders
Dizziness
|
5.6%
2/36 • Number of events 2 • Up to 7 months.
|
|
Nervous system disorders
Syncope
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Vascular disorders
Aneurism
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Gastrointestinal disorders
Diarrhea
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
2/36 • Number of events 2 • Up to 7 months.
|
|
General disorders
Fever
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Infections and infestations
Clostridium Difficle
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Infections and infestations
Pneumonia
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Infections and infestations
Sepsis
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Blood and lymphatic system disorders
Anemia
|
5.6%
2/36 • Number of events 2 • Up to 7 months.
|
|
Blood and lymphatic system disorders
Hypercoagulability
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Endocrine disorders
Adrenal insufficiency
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
General disorders
Fatigue
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Infections and infestations
Urinary Tract Infection
|
5.6%
2/36 • Number of events 2 • Up to 7 months.
|
|
Investigations
Neutropenia
|
5.6%
2/36 • Number of events 2 • Up to 7 months.
|
|
Investigations
Platelet count decreased
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Investigations
White blood cell decreased
|
5.6%
2/36 • Number of events 2 • Up to 7 months.
|
|
Nervous system disorders
Cognitive disturbance
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Nervous system disorders
Presyncope
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Investigations
Lymphocyte count decreased
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.6%
2/36 • Number of events 2 • Up to 7 months.
|
|
Gastrointestinal disorders
Dental caries
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Psychiatric disorders
Mania
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Psychiatric disorders
Psychosis
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.3%
3/36 • Number of events 3 • Up to 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Infections and infestations
Lung Infection
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Vascular disorders
Thromboembolic event
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Cardiac disorders
Sinus tachycardia
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Cardiac disorders
Cardiomyopathy
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Cardiac disorders
Heart Failure
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.6%
2/36 • Number of events 2 • Up to 7 months.
|
Other adverse events
| Measure |
Drug Treatment
n=36 participants at risk
Cemiplimab, Paclitaxel, Carboplatin (not mandatory), Doxorubicin, Cyclophosphamide
Cemiplimab: 350 mg, IV, Day 1 of Cycle 1-2 (3-week cycle)
Paclitaxel: 80 mg/m\^2, IV, Day 1,8 and 15 of Cycles 1-4 (3-week cycle)
Carboplatin (not mandatory): Area under curve (AUC)=6, IV, Day 1 of Cycles 1-4 of Paclitaxel cycles (3-week cycle)
Doxorubicin: 60 g/m\^2, IV, Day 1 of Cycles 1-4 of ddAC (2-week cycle)
Cyclophosphamide: 600 g/m\^2, IV, Day 1 of Cycles 1-4 of dose-dense Adriamycin (Doxorubicin) and Cyclophosphamide (ddAC) (2-week cycle)
|
|---|---|
|
Investigations
Weight gain
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Investigations
Weight loss
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Investigations
White blood cell decreased
|
16.7%
6/36 • Number of events 7 • Up to 7 months.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Metabolism and nutrition disorders
Acidosis
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Endocrine disorders
Adrenal insufficiency
|
5.6%
2/36 • Number of events 2 • Up to 7 months.
|
|
Investigations
Alkaline phosphatase increased
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Blood and lymphatic system disorders
Anemia
|
13.9%
5/36 • Number of events 7 • Up to 7 months.
|
|
Psychiatric disorders
Anxiety
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Investigations
Aspartate aminotransferase increased
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.3%
3/36 • Number of events 3 • Up to 7 months.
|
|
Reproductive system and breast disorders
Breast pain
|
5.6%
2/36 • Number of events 2 • Up to 7 months.
|
|
Injury, poisoning and procedural complications
Bruising
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Gastrointestinal disorders
Dental caries
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
2/36 • Number of events 2 • Up to 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.6%
2/36 • Number of events 2 • Up to 7 months.
|
|
General disorders
Edema limbs
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
General disorders
Fatigue
|
8.3%
3/36 • Number of events 3 • Up to 7 months.
|
|
General disorders
Gait disturbance
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Vascular disorders
Hypertension
|
22.2%
8/36 • Number of events 13 • Up to 7 months.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.8%
1/36 • Number of events 2 • Up to 7 months.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.8%
1/36 • Number of events 2 • Up to 7 months.
|
|
Vascular disorders
Hypotension
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Endocrine disorders
Hypothyroidism
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
General disorders
Infusion related reaction
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Psychiatric disorders
Insomnia
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Investigations
Leukocytosis
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Investigations
Lymphocyte count decreased
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Gastrointestinal disorders
Nausea
|
8.3%
3/36 • Number of events 4 • Up to 7 months.
|
|
Investigations
Neutrophil count decreased
|
19.4%
7/36 • Number of events 11 • Up to 7 months.
|
|
Metabolism and nutrition disorders
Obesity
|
30.6%
11/36 • Number of events 12 • Up to 7 months.
|
|
General disorders
Pain
|
5.6%
2/36 • Number of events 2 • Up to 7 months.
|
|
Nervous system disorders
Paresthesia
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Investigations
Platelet count decreased
|
11.1%
4/36 • Number of events 7 • Up to 7 months.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.8%
1/36 • Number of events 1 • Up to 7 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place