Triple Negative Breast CancerPhase 2STEROID-LITENCT07914309

Dexamethasone De-Escalation in Neoadjuvant Chemoimmunotherapy for Triple-Negative Breast Cancer

A Phase 2 study testing Dexamethasone, Famotidine and Diphenhydramine in people with Triple Negative Breast Cancer and Triple Negative Breast Cancer (TNBC), run by Washington University School of Medicine at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

This is a single-arm, open-label, phase II trial designed to prospectively evaluate the safety and feasibility of dexamethasone de-escalation in patients undergoing standard neoadjuvant chemotherapy and immunotherapy for triple negative breast cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Triple Negative Breast Cancer, Triple Negative Breast Cancer (TNBC), Breast Cancer
What is being tested?: Dexamethasone, Famotidine and Diphenhydramine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 17 participants
Where: 2 sitesUnited States
Study dates: 30 Nov 2026to 31 May 2033
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically or cytologically confirmed, untreated, locally advanced, non-metastatic triple-negative breast cancer.
Planning to receive the KEYNOTE 522 regimen as per standard of care.
At least 18 years of age.
ECOG performance status ≤ 1
People of childbearing potential and people able to father a child must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 12 months after the last dose of any of the KEYNOTE 522 drugs.
Ability to understand and willingness to sign an IRB-approved written informed consent document.

Who cannot join

Prior treatment with carboplatin.
Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessments occurring during the study. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial
A history of allergic reactions attributed to polyethoxylated castor oil-containing medications.
Active autoimmune disease for which they are currently receiving systemic steroid therapy or other form of immunosuppressive therapy. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal pituitary insufficiency) is not considered a form of systemic treatment.
Uncontrolled intercurrent illness, including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or active tuberculosis.
Pregnant and/or breastfeeding.

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HIV-infected if not on effective anti-retroviral therapy with an undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing is not required in the absence of a known history of infection.
Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing is not required in the absence of a known history of infection.
History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing is not required in the absence of a known history of infection.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Faisal Fa'ak, MD contact

314-362-9303

faak@wustl.edu

United States2 sites

St. Luke's Hospital
Kansas City, Missouri, 64111
Timothy Pluard, MD, 816-932-3300
Timothy Pluard, MD
Washington University School of Medicine
St Louis, Missouri, 63110
Faisal Fa'ak, MD, 314-362-9303, faak@wustl.edu
Faisal Fa'ak, MD

Other trials in United States

About this study

Official title: STEROID-LITE: A Phase II Study Evaluating the Safety and Feasibility of Dexamethasone De-Escalation in Neoadjuvant Chemoimmunotherapy for Triple-Negative Breast Cancer

Conditions: Triple Negative Breast Cancer, Triple Negative Breast Cancer (TNBC), Breast Cancer
Being tested: Dexamethasone, Famotidine, Diphenhydramine, Olanzapine, Paclitaxel
Keywords: Triple Negative Breast Cancer, Dexamethasone, Neoadjuvant, Pembrolizumab
Medical subject headings: Triple Negative Breast Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexamethasoneDrug
Also called Hemady
Dexamethasone will be administered intravenously at a dose of 10 mg prior to treatment of the KEYNOTE 522 regimen.
FamotidineDrug
Also called Pepcid, Zantac 360
Famotidine will be administered intravenously at a dose of 20 mg prior to treatment of the KEYNOTE 522 regimen.
DiphenhydramineDrug
Also called Benadryl
Diphenhydramine will be administered intravenously at a dose of 50 mg prior to treatment of the KEYNOTE 522 regimen.
OlanzapineDrug
Also called Zyprexa
Olanzapine will be administered orally at a dose of 5-10 mg 30 minutes prior to treatment of the KEYNOTE 522 regimen.
Administration of olanzapine will occur on Day 1 and Day 4 of the 21-day cycles. Olanzapine will be administered the from weeks 3-14 of the KEYSTONE 522 regimen.
PaclitaxelDrug
Also called KEYNOTE 522
Paclitaxel will be administered according to standard of care guidelines as part of the KEYNOTE 522 regimen. Paclitaxel will be administered on Days 1, 8, and 15 of Cycles 1-4. Each cycle is 21 days in length.
CarboplatinDrug
Also called KEYNOTE 522
Carboplatin will be administered according to standard of care guidelines as part of the KEYNOTE 522 regimen. Carboplatin will be administered on Days 1, 8, and 15 of Cycles 1-4. Each cycle is 21 days in length.
PembrolizumabBiological
Also called KEYNOTE 522
Pembrolizumab will be administered according to standard of care guidelines as part of the KEYNOTE 522 regimen. Paclitaxel will be administered on Day 1 of Cycles 1-8. Each cycle is 21 days in length.
DoxorubicinDrug
Also called KEYNOTE 522
Doxorubicin will be administered according to standard of care guidelines as part of the KEYNOTE 522 regimen. Doxorubicin will be administered on Day 1 of Cycles 5-8. Each cycle is 21 days in length.
CyclophosphamideDrug
Also called KEYNOTE 522
Cyclophosphamide will be administered according to standard of care guidelines as part of the KEYNOTE 522 regimen. Cyclophosphamide will be administered on Day 1 of Cycles 5-8. Each cycle is 21 days in length.

Study groups in NCT07914309
Study group	Role	What they receive
Dexamethasone sparing supportive care	Experimental	Patients will be enrolled prior to start of standard of care (SOC) neoadjuvant systemic therapy (NAST) which is the KEYNOTE 522 regimen consisting of four 21-day cycles of paclitaxel and carboplatin (Days 1, 8, 15) and pembrolizumab (Day 1), followed by four 14- or 21-day cycles of doxorubicin, cyclophosphamide, and pembrolizumab (all on Day 1). During the first 2 weeks of paclitaxel/carboplatin infusions, patients will receive standard premedication of dexamethasone IV, famotidine IV, and diphenhydramine IV, approximately 30 minutes before treatment. If no HSR occurs, dexamethasone will be discontinued for the remaining 10 weeks of paclitaxel/carboplatin infusions, while famotidine and diphenhydramine will be continued as per standard practice. For the remaining weeks of KEYNOTE 522, dexamethasone premedication will be replaced with olanzapine 5-10 mg PO on Days 1-4 of each cycle, to be given with an NK1 receptor antagonist and a 5-HT3 receptor agonist. Receives: Drug: Dexamethasone; Drug: Famotidine; Drug: Diphenhydramine; Drug: Olanzapine; Drug: Paclitaxel; Drug: Carboplatin; Biological: Pembrolizumab; Drug: Doxorubicin; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of hypersensitivity reactions (HSRs) requiring reintroduction of dexamethasone
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.
Measured: During the 10 dexamethasone-free weekly paclitaxel/carboplatin containing infusions (total estimated time: 10 weeks)

Secondary outcomes (15)

Pathologic complete response (pCR) rate
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.
Measured: At time of first progression or at time of surgery (total estimated time: 6 months )
Event-free survival (EFS)
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.
Measured: 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)
Relative dose intensity - paclitaxel
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.
Measured: Start of paclitaxel treatment to completion of paclitaxel treatment (total estimated time: 12 weeks)
Relative dose intensity - carboplatin
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.
Measured: Start of carboplatin treatment to completion of carboplatin treatment (total estimated time: 12 weeks)
Relative dose intensity - doxorubicin
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.
Measured: Start of doxorubicin treatment to completion of doxorubicin treatment (total estimated time: 12 weeks)
Relative dose intensity - cyclophosphamide
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.
Measured: Start of cyclophosphamide treatment to completion of cyclophosphamide treatment (total estimated time: 12 weeks)
Relative dose intensity - pembrolizumab
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.
Measured: Start of pembrolizumab treatment to completion of pembrolizumab treatment (total estimated time: 24 weeks)
Incidence of treatment delay
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.
Measured: Start of paclitaxel treatment to completion of paclitaxel treatment (total estimated time: 24 weeks)
Incidence of dose reduction
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.
Measured: Start of paclitaxel treatment to completion of paclitaxel treatment (total estimated time: 24 weeks)
Incidence of treatment discontinuation
Treatment discontinuation is defined as permanent cessation of one or more planned systemic therapy components before completion of the intended neoadjuvant regimen.
Measured: Start of paclitaxel treatment to completion of paclitaxel treatment (total estimated time: 24 weeks)
Incidence of completion of planned neoadjuvant therapy
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.
Measured: Start of KEYNOTE 522 regimen to completion of KEYNOTE 522 regimen (total estimated time: 24 weeks)
Incidence of corticosteroid rescue
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.
Measured: Start of KEYNOTE 522 regimen to completion of KEYNOTE 522 regimen (total estimated time: 24 weeks)
Incidence of corticosteroid reintroduction
Reintroduction of corticosteroids is defined as resumption of routine corticosteroid premedication or antiemetic corticosteroid prophylaxis after protocol-specified discontinuation.
Measured: Start of KEYNOTE 522 regimen to completion of KEYNOTE 522 regimen (total estimated time: 24 weeks)
Immune-related adverse events (AEs) as assessed by CTCAE v6.0.
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.
Measured: Start of KEYNOTE 522 treatment through 90 days after last dose of any KEYNOTE 522 drug (total estimated time: 36 weeks)
Change in Patient-reported Toxicity as Measured by PRO-CTCAE
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.
Measured: On day 1 of cycles 1-8 (each cycle is 21 days) (total estimated time: 21 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Nov 202631 May 2033

First posted3 Nov 2026
Study start30 Nov 2026 (estimated)
Primary completion8 Feb 2028 (estimated)
Study completion31 May 2033 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
More trials run by Washington University School of MedicineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 17 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07914309
Sponsor's protocol ID: 202610154
Acronym: STEROID-LITE
Status last verified: Oct 2026
First submitted: 27 Oct 2026
Last updated: 3 Nov 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: STEROID-LITE: A Phase II Study Evaluating the Safety and Feasibility of Dexamethasone De-Escalation in Neoadjuvant Chemoimmunotherapy for Triple-Negative Breast Cancer
ClinicalTrials.gov ID: NCT07914309
Acronym / sponsor ID: STEROID-LITE / 202610154
Conditions: Triple Negative Breast Cancer, Triple Negative Breast Cancer (TNBC), Breast Cancer
Keywords: Triple Negative Breast Cancer, Dexamethasone, Neoadjuvant, Pembrolizumab
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 17 participants (estimated)
Lead sponsor: Washington University School of MedicineUniversity, hospital or other
Study start: 30 Nov 2026 (estimated)
Primary completion: 8 Feb 2028 (estimated)
Study completion: 31 May 2033 (estimated)
First posted: 3 Nov 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Dexamethasone sparing supportive care	Experimental	Drug: Dexamethasone, Drug: Famotidine, Drug: Diphenhydramine, Drug: Olanzapine, Drug: Paclitaxel, Drug: Carboplatin, Biological: Pembrolizumab, Drug: Doxorubicin, Drug: CyclophosphamidePatients will be enrolled prior to start of standard of care (SOC) neoadjuvant systemic therapy (NAST) which is the KEYNOTE 522 regimen consisting of four 21-day cycles of paclitaxel and carboplatin (Days 1, 8, 15) and pembrolizumab (Day 1), followed by four 14- or 21-day cycles of doxorubicin, cyclophosphamide, and pembrolizumab (all on Day 1). During the first 2 weeks of paclitaxel/carboplatin infusions, patients will receive standard premedication of dexamethasone IV, famotidine IV, and diphenhydramine IV, approximately 30 minutes before treatment. If no HSR occurs, dexamethasone will be discontinued for the remaining 10 weeks of paclitaxel/carboplatin infusions, while famotidine and diphenhydramine will be continued as per standard practice. For the remaining weeks of KEYNOTE 522, dexamethasone premedication will be replaced with olanzapine 5-10 mg PO on Days 1-4 of each cycle, to be given with an NK1 receptor antagonist and a 5-HT3 receptor agonist.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Histologically or cytologically confirmed, untreated, locally advanced, non-metastatic triple-negative breast cancer.
Planning to receive the KEYNOTE 522 regimen as per standard of care.
At least 18 years of age.
ECOG performance status ≤ 1
People of childbearing potential and people able to father a child must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 12 months after the last dose of any of the KEYNOTE 522 drugs.

Key exclusion criteria (9 listed)

Prior treatment with carboplatin.
Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessments occurring during the study. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial
A history of allergic reactions attributed to polyethoxylated castor oil-containing medications.
Active autoimmune disease for which they are currently receiving systemic steroid therapy or other form of immunosuppressive therapy. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal pituitary insufficiency) is not considered a form of systemic treatment.
Uncontrolled intercurrent illness, including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or active tuberculosis.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DexamethasoneAlso: HemadyDexamethasone will be administered intravenously at a dose of 10 mg prior to treatment of the KEYNOTE 522 regimen.	Drug	Dexamethasone sparing supportive care
FamotidineAlso: Pepcid, Zantac 360Famotidine will be administered intravenously at a dose of 20 mg prior to treatment of the KEYNOTE 522 regimen.	Drug	Dexamethasone sparing supportive care
DiphenhydramineAlso: BenadrylDiphenhydramine will be administered intravenously at a dose of 50 mg prior to treatment of the KEYNOTE 522 regimen.	Drug	Dexamethasone sparing supportive care
OlanzapineAlso: ZyprexaOlanzapine will be administered orally at a dose of 5-10 mg 30 minutes prior to treatment of the KEYNOTE 522 regimen. Administration of olanzapine will occur on Day 1 and Day 4 of the 21-day cycles. Olanzapine will be administered the from weeks 3-14 of the KEYSTONE 522 regimen.	Drug	Dexamethasone sparing supportive care
PaclitaxelAlso: KEYNOTE 522Paclitaxel will be administered according to standard of care guidelines as part of the KEYNOTE 522 regimen. Paclitaxel will be administered on Days 1, 8, and 15 of Cycles 1-4. Each cycle is 21 days in length.	Drug	Dexamethasone sparing supportive care
CarboplatinAlso: KEYNOTE 522Carboplatin will be administered according to standard of care guidelines as part of the KEYNOTE 522 regimen. Carboplatin will be administered on Days 1, 8, and 15 of Cycles 1-4. Each cycle is 21 days in length.	Drug	Dexamethasone sparing supportive care
PembrolizumabAlso: KEYNOTE 522Pembrolizumab will be administered according to standard of care guidelines as part of the KEYNOTE 522 regimen. Paclitaxel will be administered on Day 1 of Cycles 1-8. Each cycle is 21 days in length.	Biological	Dexamethasone sparing supportive care
DoxorubicinAlso: KEYNOTE 522Doxorubicin will be administered according to standard of care guidelines as part of the KEYNOTE 522 regimen. Doxorubicin will be administered on Day 1 of Cycles 5-8. Each cycle is 21 days in length.	Drug	Dexamethasone sparing supportive care
CyclophosphamideAlso: KEYNOTE 522Cyclophosphamide will be administered according to standard of care guidelines as part of the KEYNOTE 522 regimen. Cyclophosphamide will be administered on Day 1 of Cycles 5-8. Each cycle is 21 days in length.	Drug	Dexamethasone sparing supportive care

Primary outcome

Incidence of hypersensitivity reactions (HSRs) requiring reintroduction of dexamethasone
Time frame: 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.

15 secondary outcomes

Pathologic complete response (pCR) rate
Time frame: At time of first progression or at time of surgery (total estimated time: 6 months )
Event-free survival (EFS)
Time frame: 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)
Relative dose intensity - paclitaxel
Time frame: Start of paclitaxel treatment to completion of paclitaxel treatment (total estimated time: 12 weeks)
Relative dose intensity - carboplatin
Time frame: Start of carboplatin treatment to completion of carboplatin treatment (total estimated time: 12 weeks)
Relative dose intensity - doxorubicin
Time frame: Start of doxorubicin treatment to completion of doxorubicin treatment (total estimated time: 12 weeks)
Relative dose intensity - cyclophosphamide
Time frame: Start of cyclophosphamide treatment to completion of cyclophosphamide treatment (total estimated time: 12 weeks)
Relative dose intensity - pembrolizumab
Time frame: Start of pembrolizumab treatment to completion of pembrolizumab treatment (total estimated time: 24 weeks)
Incidence of treatment delay
Time frame: Start of paclitaxel treatment to completion of paclitaxel treatment (total estimated time: 24 weeks)
Incidence of dose reduction
Time frame: Start of paclitaxel treatment to completion of paclitaxel treatment (total estimated time: 24 weeks)
Incidence of treatment discontinuation
Time frame: Start of paclitaxel treatment to completion of paclitaxel treatment (total estimated time: 24 weeks)
Incidence of completion of planned neoadjuvant therapy
Time frame: Start of KEYNOTE 522 regimen to completion of KEYNOTE 522 regimen (total estimated time: 24 weeks)
Incidence of corticosteroid rescue
Time frame: Start of KEYNOTE 522 regimen to completion of KEYNOTE 522 regimen (total estimated time: 24 weeks)
Incidence of corticosteroid reintroduction
Time frame: Start of KEYNOTE 522 regimen to completion of KEYNOTE 522 regimen (total estimated time: 24 weeks)
Immune-related adverse events (AEs) as assessed by CTCAE v6.0.
Time frame: Start of KEYNOTE 522 treatment through 90 days after last dose of any KEYNOTE 522 drug (total estimated time: 36 weeks)
Change in Patient-reported Toxicity as Measured by PRO-CTCAE
Time frame: On day 1 of cycles 1-8 (each cycle is 21 days) (total estimated time: 21 weeks)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Faisal Fa'ak, MD contact

314-362-9303

faak@wustl.edu

Faisal Fa'ak, MD principal investigator

Washington University School of Medicine

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Faisal Fa'ak, MD (314-362-9303, faak@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of hypersensitivity reactions (HSRs) requiring reintroduction of dexamethasone (time frame: During the 10 dexamethasone-free weekly paclitaxel/carboplatin containing infusions (total estimated time: 10 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07914309.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.