Trial Outcomes & Findings for CFI-400945 and Durvalumab in Patients With Advanced Triple Negative Breast Cancer (NCT NCT04176848)
NCT ID: NCT04176848
Last Updated: 2025-10-09
Results Overview
Defined as percentage of participants with objective response over all participants enrolled. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
ACTIVE_NOT_RECRUITING
PHASE2
15 participants
24 months
2025-10-09
Participant Flow
Participants were assigned after the eligibility criteria were met.
Participant milestones
| Measure |
CFI-400945 + Durvalumab
CFI-400945: Cycle 1: Days 1-7, then Days 15-21; Cycle 2 on: CFI-400945 orally once daily
Durvalumab: Cycle 2 on: Durvalumab 1500mg IV on Day 1 (28 day cycles)
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CFI-400945 + Durvalumab
n=15 Participants
CFI-400945: Cycle 1: Days 1-7, then Days 15-21; Cycle 2 on: CFI-400945 orally once daily
Durvalumab: Cycle 2 on: Durvalumab 1500mg IV on Day 1 (28 day cycles)
|
|---|---|
|
Age, Continuous
|
56 years
n=15 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=15 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=15 Participants
|
|
Region of Enrollment
Canada
|
15 participants
n=15 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
7 Participants
n=15 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
8 Participants
n=15 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: All patients enrolled
Defined as percentage of participants with objective response over all participants enrolled. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
Outcome measures
| Measure |
CFI-400945 + Durvalumab
n=15 Participants
CFI-400945: Cycle 1: Days 1-7, then Days 15-21; Cycle 2 on: CFI-400945 orally once daily
Durvalumab: Cycle 2 on: Durvalumab 1500mg IV on Day 1 (28 day cycles)
|
|---|---|
|
Objective Response Rate
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: All patients enrolled
Defined as percentage of participants with disease control over all participants randomized. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter (LD) of target lesions; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Disease control=CR or PR or SD\> 16 weeks in duration)
Outcome measures
| Measure |
CFI-400945 + Durvalumab
n=15 Participants
CFI-400945: Cycle 1: Days 1-7, then Days 15-21; Cycle 2 on: CFI-400945 orally once daily
Durvalumab: Cycle 2 on: Durvalumab 1500mg IV on Day 1 (28 day cycles)
|
|---|---|
|
Disease Control Rate
|
2 Participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: All patients enrolled
Defined as percentage of participants with immune-related response over all participants enrolled. Per Immune-Related modified Response Evaluation Criteria In Solid Tumors Criteria and assessed by computed tomography (CT) or MRI: Immune Complete Response (iCR), Disappearance of all target and non-target lesions; Immune Partial Response (iPR), the tumor load of the target lesion is reduced by ≤30% compared to the baseline, or in the case of complete remission of the target lesion, one or more non-target lesions can still be distinguished; Immune-Related Response (iOR) = iCR + iPR.
Outcome measures
| Measure |
CFI-400945 + Durvalumab
n=15 Participants
CFI-400945: Cycle 1: Days 1-7, then Days 15-21; Cycle 2 on: CFI-400945 orally once daily
Durvalumab: Cycle 2 on: Durvalumab 1500mg IV on Day 1 (28 day cycles)
|
|---|---|
|
Immune-Related Response Rate (iRECIST) of CFI-400945 Given With Durvalumab
|
0 Participants
|
Adverse Events
CFI-400945 + Durvalumab
Serious adverse events
| Measure |
CFI-400945 + Durvalumab
n=15 participants at risk
CFI-400945: Cycle 1: Days 1-7, then Days 15-21; Cycle 2 on: CFI-400945 orally once daily
Durvalumab: Cycle 2 on: Durvalumab 1500mg IV on Day 1 (28 day cycles)
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
6.7%
1/15 • 24 months
|
|
Gastrointestinal disorders
Dysphagia
|
6.7%
1/15 • 24 months
|
|
General disorders
Sudden death NOS
|
6.7%
1/15 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.7%
1/15 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.7%
1/15 • 24 months
|
Other adverse events
| Measure |
CFI-400945 + Durvalumab
n=15 participants at risk
CFI-400945: Cycle 1: Days 1-7, then Days 15-21; Cycle 2 on: CFI-400945 orally once daily
Durvalumab: Cycle 2 on: Durvalumab 1500mg IV on Day 1 (28 day cycles)
|
|---|---|
|
Endocrine disorders
Other endocrine disorders
|
6.7%
1/15 • 24 months
|
|
Eye disorders
Blurred vision
|
13.3%
2/15 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
1/15 • 24 months
|
|
Gastrointestinal disorders
Constipation
|
20.0%
3/15 • 24 months
|
|
Gastrointestinal disorders
Dyspepsia
|
13.3%
2/15 • 24 months
|
|
General disorders
Edema limbs
|
6.7%
1/15 • 24 months
|
|
General disorders
Fatigue
|
66.7%
10/15 • 24 months
|
|
General disorders
Fever
|
6.7%
1/15 • 24 months
|
|
General disorders
Non-cardiac chest pain
|
20.0%
3/15 • 24 months
|
|
General disorders
Pain
|
6.7%
1/15 • 24 months
|
|
Infections and infestations
Bronchial infection
|
6.7%
1/15 • 24 months
|
|
Infections and infestations
Lung infection
|
6.7%
1/15 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
6.7%
1/15 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
46.7%
7/15 • 24 months
|
|
Nervous system disorders
Dizziness
|
13.3%
2/15 • 24 months
|
|
Nervous system disorders
Neuralgia
|
13.3%
2/15 • 24 months
|
|
Nervous system disorders
Dysarthria
|
13.3%
2/15 • 24 months
|
|
Nervous system disorders
Headache
|
33.3%
5/15 • 24 months
|
|
Nervous system disorders
Paresthesia
|
6.7%
1/15 • 24 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
13.3%
2/15 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
40.0%
6/15 • 24 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
6.7%
1/15 • 24 months
|
|
Skin and subcutaneous tissue disorders
Other skin and subcutaneous tissue disorders
|
6.7%
1/15 • 24 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.7%
1/15 • 24 months
|
|
Vascular disorders
Hot flashes
|
26.7%
4/15 • 24 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.7%
1/15 • 24 months
|
|
Vascular disorders
Thromboembolic event
|
6.7%
1/15 • 24 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
13.3%
2/15 • 24 months
|
|
Gastrointestinal disorders
Nausea
|
46.7%
7/15 • 24 months
|
|
Gastrointestinal disorders
Vomiting
|
6.7%
1/15 • 24 months
|
|
General disorders
Localized edema
|
6.7%
1/15 • 24 months
|
|
Hepatobiliary disorders
Hepatic pain
|
6.7%
1/15 • 24 months
|
|
Immune system disorders
Allergic reaction
|
6.7%
1/15 • 24 months
|
|
Infections and infestations
Pleural infection
|
6.7%
1/15 • 24 months
|
|
Infections and infestations
Skin infection
|
6.7%
1/15 • 24 months
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
5/15 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
2/15 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.7%
1/15 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
13.3%
2/15 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
6.7%
1/15 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.3%
2/15 • 24 months
|
|
Metabolism and nutrition disorders
Neck pain
|
6.7%
1/15 • 24 months
|
|
Nervous system disorders
Seizure
|
6.7%
1/15 • 24 months
|
|
Nervous system disorders
Syncope
|
6.7%
1/15 • 24 months
|
|
Psychiatric disorders
Anxiety
|
6.7%
1/15 • 24 months
|
|
Psychiatric disorders
Insomnia
|
6.7%
1/15 • 24 months
|
|
Reproductive system and breast disorders
Breast pain
|
6.7%
1/15 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
66.7%
10/15 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.7%
1/15 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
6.7%
1/15 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
6.7%
1/15 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place