Trial · NCT07914309
Dexamethasone De-Escalation in Neoadjuvant Chemoimmunotherapy for Triple-Negative Breast Cancer
NCT07914309, Phase 2, Not yet recruiting, Washington University School of Medicine
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Dexamethasone De-Escalation in Neoadjuvant Chemoimmunotherapy for Triple-Negative Breast Cancer. Trials, record NCT07914309. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07914309
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dexamethasone De-Escalation in Neoadjuvant Chemoimmunotherapy for Triple-Negative Breast Cancer
- NCT number
- NCT07914309
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 17 participants, estimated
- Lead sponsor
- Washington University School of Medicine
- Conditions
- Triple Negative Breast Cancer, Triple Negative Breast Cancer (TNBC), Breast Cancer
- Interventions
- Dexamethasone, Famotidine, Diphenhydramine, Olanzapine, Paclitaxel, Carboplatin, Pembrolizumab, Doxorubicin, Cyclophosphamide
- First posted
- 2026-11-03
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of hypersensitivity reactions (HSRs) requiring reintroduction of dexamethasone | During the 10 dexamethasone-free weekly paclitaxel/carboplatin containing infusions (total estimated time: 10 weeks) | The total number of patients experiencing HSRs requiring reintroduction of dexamethasone during the 10 dexamethasone-free weeks, \& HSR incidence rate will be calculated as the total number of patients with HSRs divided by the total number of evaluable patients. HSRs include flushing, rash, pruritus, bronchospasm, hypotension \& anaphylaxis. Reintroduction of dexamethasone will occur with the occurrence of a clinically significant HSR (grade ≥2 or any reaction that necessitates infusion interruption/rescue medication/medical intervention) during a dexamethasone-free paclitaxel infusion, recurrent grade 1 HSR despite premedication with antihistamines, when the investigator concludes that continued omission of dexamethasone is not in the patient's best interest, delayed HSRs attributed to paclitaxel or carboplatin that require systemic corticosteroid therapy \& where the investigator determines that corticosteroid premedication is essential to safely continue treatment. |
| Secondary | Pathologic complete response (pCR) rate | At time of first progression or at time of surgery (total estimated time: 6 months ) | pCR is defined as the absence of viable invasive cancer in the breast and lymph nodes (ypT0ypN0 or ypT0/isypN0). All other outcomes are defined as "not pCR" including 1) residual disease (defined as invasive cancer in the breast and/or lymph nodes) or 2) not going to surgery. |
| Secondary | Event-free survival (EFS) | Start of KEYNOTE 522 regimen to time of progression prior to surgery, invasive recurrence after surgery, new contralateral breast cancer, or death due to any cause (total estimated time: 66 months) | Event-free survival (EFS) is the interval from the date of the first dose of any of the KEYNOTE 522 drugs to the date of the earliest occurrence of any of the following events: progression prior to surgery, invasive recurrence after surgery, new contralateral breast cancer, or death due to any cause. New non-breast primaries are not included as events. Patients last known to be alive who have not experienced any of these events are censored at their last contact date. |
| Secondary | Relative dose intensity - paclitaxel | Start of paclitaxel treatment to completion of paclitaxel treatment (total estimated time: 12 weeks) | Relative dose intensity (RDI) is defined as the ratio of the actual dose intensity received to the planned dose intensity for each systemic therapy agent, expressed as a percentage. Dose intensity will account for both delivered dose and treatment duration. |
| Secondary | Relative dose intensity - carboplatin | Start of carboplatin treatment to completion of carboplatin treatment (total estimated time: 12 weeks) | Relative dose intensity (RDI) is defined as the ratio of the actual dose intensity received to the planned dose intensity for each systemic therapy agent, expressed as a percentage. Dose intensity will account for both delivered dose and treatment duration. |
| Secondary | Relative dose intensity - doxorubicin | Start of doxorubicin treatment to completion of doxorubicin treatment (total estimated time: 12 weeks) | Relative dose intensity (RDI) is defined as the ratio of the actual dose intensity received to the planned dose intensity for each systemic therapy agent, expressed as a percentage. Dose intensity will account for both delivered dose and treatment duration. |
| Secondary | Relative dose intensity - cyclophosphamide | Start of cyclophosphamide treatment to completion of cyclophosphamide treatment (total estimated time: 12 weeks) | Relative dose intensity (RDI) is defined as the ratio of the actual dose intensity received to the planned dose intensity for each systemic therapy agent, expressed as a percentage. Dose intensity will account for both delivered dose and treatment duration. |
| Secondary | Relative dose intensity - pembrolizumab | Start of pembrolizumab treatment to completion of pembrolizumab treatment (total estimated time: 24 weeks) | Relative dose intensity (RDI) is defined as the ratio of the actual dose intensity received to the planned dose intensity for each systemic therapy agent, expressed as a percentage. Dose intensity will account for both delivered dose and treatment duration. |
| Secondary | Incidence of treatment delay | Start of paclitaxel treatment to completion of paclitaxel treatment (total estimated time: 24 weeks) | A treatment delay is defined as any administration of the KEYNOTE 522 more than 7 days after the scheduled treatment date. For weekly paclitaxel, a delay will be defined as \>7 days from the scheduled treatment date. |
| Secondary | Incidence of dose reduction | Start of paclitaxel treatment to completion of paclitaxel treatment (total estimated time: 24 weeks) | A dose reduction is defined as any reduction from the planned dose of any KEYNOTE 522 drugs due to toxicity, tolerability, laboratory abnormality, or other clinical consideration. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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/NCT07914309
GET https://conductscience.org/api/trials/v1/NCT07914309/registered