Trial · NCT04176848
CFI-400945 and Durvalumab in Patients With Advanced Triple Negative Breast Cancer
NCT04176848, Phase 2, Active not recruiting, Canadian Cancer Trials Group; results first posted 2024-08-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. CFI-400945 and Durvalumab in Patients With Advanced Triple Negative Breast Cancer. Trials, record NCT04176848. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04176848
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- CFI-400945 and Durvalumab in Patients With Advanced Triple Negative Breast Cancer
- NCT number
- NCT04176848
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 15 participants, actual
- Lead sponsor
- Canadian Cancer Trials Group
- Conditions
- Breast Cancer
- Interventions
- CFI-400945, Durvalumab
- First posted
- 2019-11-25
- Last updated
- 2026-02-18
- Results first posted
- 2024-08-09
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate | 24 months | 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. |
| Secondary | Disease Control Rate | 24 months | 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) |
| Secondary | Immune-Related Response Rate (iRECIST) of CFI-400945 Given With Durvalumab | 24 months | 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. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate | 24 months | All patients enrolled | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Control Rate | 24 months | All patients enrolled | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Immune-Related Response Rate (iRECIST) of CFI-400945 Given With Durvalumab | 24 months | All patients enrolled | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate | CFI-400945 + Durvalumab | 0 | Participants | ||
| Disease Control Rate | CFI-400945 + Durvalumab | 2 | Participants | ||
| Immune-Related Response Rate (iRECIST) of CFI-400945 Given With Durvalumab | CFI-400945 + Durvalumab | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CFI-400945 + Durvalumab | 15 | |
| Overall Study | COMPLETED | CFI-400945 + Durvalumab | 15 | |
| Overall Study | NOT COMPLETED | CFI-400945 + Durvalumab | 0 |
Source ClinicalTrials.gov
Adverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Other endocrine disorders | Endocrine disorders | CFI-400945 + Durvalumab | 1 | 15 | |
| other | Blurred vision | Eye disorders | CFI-400945 + Durvalumab | 2 | 15 | |
| other | Abdominal pain | Gastrointestinal disorders | CFI-400945 + Durvalumab | 1 | 15 | |
| other | Constipation | Gastrointestinal disorders | CFI-400945 + Durvalumab | 3 | 15 | |
| other | Dyspepsia | Gastrointestinal disorders | CFI-400945 + Durvalumab | 2 | 15 | |
| other | Edema limbs | General disorders | CFI-400945 + Durvalumab | 1 | 15 | |
| other | Fatigue | General disorders | CFI-400945 + Durvalumab | 10 | 15 | |
| other | Fever | General disorders | CFI-400945 + Durvalumab | 1 | 15 | |
| other | Non-cardiac chest pain | General disorders | CFI-400945 + Durvalumab | 3 | 15 | |
| other | Pain | General disorders | CFI-400945 + Durvalumab | 1 | 15 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CFI-400945 + Durvalumab | 13 | 15 |
| Total, other adverse events | CFI-400945 + Durvalumab | 15 | 15 |
| Total, serious adverse events | CFI-400945 + Durvalumab | 4 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04176848
GET https://conductscience.org/api/trials/v1/NCT04176848/events?page=2