Trial · NCT07914309
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| 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. |
| Secondary | Incidence of treatment discontinuation | Start of paclitaxel treatment to completion of paclitaxel treatment (total estimated time: 24 weeks) | Treatment discontinuation is defined as permanent cessation of one or more planned systemic therapy components before completion of the intended neoadjuvant regimen. |
| Secondary | Incidence of completion of planned neoadjuvant therapy | Start of KEYNOTE 522 regimen to completion of KEYNOTE 522 regimen (total estimated time: 24 weeks) | Completion of planned neoadjuvant therapy is defined as receipt of all planned paclitaxel/carboplatin and anthracycline/cyclophosphamide phases with pembrolizumab, allowing for protocol-permitted delays, dose reductions, or holds, followed by definitive surgery when clinically appropriate. |
| Secondary | Incidence of corticosteroid rescue | Start of KEYNOTE 522 regimen to completion of KEYNOTE 522 regimen (total estimated time: 24 weeks) | Rescue corticosteroid use is defined as corticosteroid administration given acutely for management of suspected hypersensitivity reactions (HSRs), nausea/vomiting, immune-related toxicity, or another treatment-related event after planned dexamethasone omission. |
| Secondary | Incidence of corticosteroid reintroduction | Start of KEYNOTE 522 regimen to completion of KEYNOTE 522 regimen (total estimated time: 24 weeks) | Reintroduction of corticosteroids is defined as resumption of routine corticosteroid premedication or antiemetic corticosteroid prophylaxis after protocol-specified discontinuation. |
| Secondary | Immune-related adverse events (AEs) as assessed by CTCAE v6.0. | Start of KEYNOTE 522 treatment through 90 days after last dose of any KEYNOTE 522 drug (total estimated time: 36 weeks) | Immune related AEs include hypothyroidism, hyperthyroidism, adrenal insufficiency, rash/maculopapular rash, pruritus, diarrhea/colitis, transaminitis, pneumonitis, increased serum creatinine, inflammatory arthritis, arthralgia (immune-mediated), ocular toxicities, infusion reactions attributed to pembrolizumab, and other suspected immune-mediated toxicities. |
| Secondary | Change in Patient-reported Toxicity as Measured by PRO-CTCAE | On day 1 of cycles 1-8 (each cycle is 21 days) (total estimated time: 21 weeks) | The PRO-CTCAE will assess the symptoms most likely to be affected by the dexamethasone-sparing supportive care strategy including insomnia, fatigue, nausea, vomiting, and decreased appetite. PRO-CTCAE asks participants about symptoms and side effects experienced over the last 7 days. Answers range from None to Very Severe (none=0 to very severe=4); Not at All to Very Much (not at all=0 to very much=4), Never to Almost Constantly (0=never to almost constantly=4) or 0/1 for absent/present. There are no standardized scoring rules yet established for how to combine attributes into a single score or how best to analyze PRO-CTCAE data longitudinally. PRO-CTCAE scores for each attribute (frequency, severity and/or interference) will be presented descriptively. A higher score represents an increased severity of symptoms and side effects. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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