Trial · NCT03971409
Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer
NCT03971409, Phase 2, Active not recruiting, Laura Huppert, MD, BA
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer. Trials, record NCT03971409. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03971409
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Avelumab With Binimetinib, Sacituzumab Govitecan, or Liposomal Doxorubicin in Treating Stage IV or Unresectable, Recurrent Triple Negative Breast Cancer
- NCT number
- NCT03971409
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 145 participants, actual
- Lead sponsor
- Laura Huppert, MD, BA
- Conditions
Stage III Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer, Invasive Breast Carcinoma, Recurrent Breast Carcinoma, Triple-Negative Breast Carcinoma, Unresectable Breast Carcinoma
- Interventions
- Anti-OX40 Antibody PF-04518600, Avelumab, Binimetinib, Utomilumab, Liposomal Doxorubicin, Sacituzumab Govitecan
- First posted
- 2019-06-03
- Last updated
- 2026-04-17
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Best Overall Response Rate (BORR) | From treatment initiation until disease progression, an estimated average of 1 year | BORR is defined as the percentage of patients achieving complete response (CR) or partial response (PR) by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 and will be reported for each arm along with 95% two-sided confidence intervals. |
| Secondary | Overall Response Rate (ORR) | From treatment initiation until disease progression, an estimated average of 1 year | ORR is defined as the percentage of patients achieving complete response (CR) or partial response (PR) assessed by Immune-Related RECIST (iRECIST) and will be reported by arm with 95% two-sided confidence intervals |
| Secondary | Clinical Benefit Rate (CBR) | 6 months | CBR is defined as the percentage of patients achieving complete response (CR), partial response (PR), or stable disease (SD) using RECIST version 1.1 at 6 months and will be reported by arm with 95% two-sided confidence intervals |
| Secondary | Median Progression-free Survival (PFS) | From treatment initiation until disease progression, an estimated average of 1 year | The median duration of progression-free survival in weeks by arm will be estimated using the Kaplan-Meier method with censoring used as needed. Median time to event and corresponding confidence intervals will be reported. |
| Secondary | Median Overall Survival (OS) | 12 months | OS is defined as the time from treatment initiation until disease progression or death, whichever comes first and will be reported by arm with 95% two-sided confidence intervals . |
| Secondary | Percentage of participants with treatment-related adverse events | Up to 30 days after completion of study treatment, approximately 13 months | An unacceptable toxicity is defined as any unexpected and clinically relevant drug-related grade 3 toxicity, or any drug-related grade 4-5 adverse event within the first cycle of therapy assessed via National Cancer Institute CTCAE version 5 criteria. Safety will be evaluated by estimating the percentage of patients who experience a clinically relevant toxicity (both patient and physician reported) for each arm with 95% two-sided confidence intervals. |
| Secondary | Change in Quality of Life at 8 Weeks Assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Measure | Baseline up to 8 weeks | Will be measured the PROMIS Global Short Form. Change scores will be compared across treatment arms using one way analysis of variance (ANOVA) with Bonferroni adjustment for post-hoc multiple comparisons. In the instance that distributional assumptions are not valid, Kruskal-Wallis one-way ANOVA will be used with Dunn's adjustment for multiple comparisons. |
| Secondary | Change in Quality of Life Over Treatment Duration Assessed by PROMIS Global Health Measure | From baseline until the date disease progression is first observed, an estimated average of 1 year | Will be measured the PROMIS Global Short Form. Change scores will be compared across treatment arms using one way analysis of variance (ANOVA) with Bonferroni adjustment for post-hoc multiple comparisons. In the instance that distributional assumptions are not valid, Kruskal-Wallis one-way ANOVA will be used with Dunn's adjustment for multiple comparisons. |
| Secondary | Change in Symptoms (Self-Reported Toxicities) at 8 Weeks Assessed by Patient-Reported Outcomes - Common Terminology Criteria for Adverse Events (PRO-CTCAE) | Baseline up to 8 weeks | Will be measured by the PRO-CTCAE criteria . The data will be presented descriptively using summary statistics and graphical representations across time points. Will assess symptom burden using Likert scores. Each attribute will be presented descriptively using summary statistics and graphical representations across time points. |
| Secondary | Change in Symptoms (Self-Reported Toxicities) Over Treatment Duration Assessed by PRO-CTCAE | From baseline until the date disease progression is first observed, an estimated average of 1 year | Will be measured by the PRO-CTCAE criteria . The data will be presented descriptively using summary statistics and graphical representations across time points. Will assess symptom burden using Likert scores. Each attribute will be presented descriptively using summary statistics and graphical representations across time points. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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/NCT03971409
GET https://conductscience.org/api/trials/v1/NCT03971409/registered