A Phase 2 interventional study of Dexamethasone and Famotidine in Triple Negative Breast Cancer, Triple Negative Breast Cancer (TNBC) and Breast Cancer, sponsored by Washington University School of Medicine. Not yet recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Supportive care
Among 645 studies in Triple Negative Breast Neoplasms with a site in United States — 164 open to participants now, 264 under way, 16 of them phase 3. Triple Negative Breast Neoplasms · United States.
Among the 645 studies in Triple Negative Breast Neoplasms with a site in United States, this one is the 495th largest by planned enrollment of the 605 interventional ones, is one of 38 that started in 2026, is one of 191 in phase 2, reaches primary completion later than 175 of the 263 other live ones, and was the 645th registered.
1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 446 are open to participants now.
This study's planned enrollment of 17 is below the median of 60 across 1,053 interventional studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →164 of the 645 studies in Triple Negative Breast Neoplasms with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 332 Triple Negative Breast Neoplasms studies recruiting now, 232 (70%) set no upper age limit and 85 (26%) stop at 75 or younger; 12 take children under 18; 6 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →645 studies; the count open now beside each. This study's row is marked.
First in 2001; this study’s year is marked. 38 started in 2026.
Median enrollment 52 across the 605 interventional studies, 90 across the 38 observational. Of the 338 that completed or were terminated, 179 (53%) have results posted.
319 of 645 have an industry lead sponsor. The 10 most frequent:
Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Washington University School of Medicine has 8 studies filed under Triple Negative Breast Neoplasms — fewer than ten, so there is no comparison to draw.
93 of the studies in Triple Negative Breast Neoplasms with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05382286Phase 3Gilead SciencesStudy of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice and Pembrolizumab in Patients With Previously Untreated, Locally Advanced Inoperable or Metastatic Triple-Negative Breast Cancer | 2027-02 |
| NCT05633654Phase 3Gilead SciencesStudy of Sacituzumab Govitecan-hziy and Pembrolizumab Versus Treatment of Physician's Choice in Patients With Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63) | 2027-06 |
| NCT04768426Stanford UniversitySerial Circulating Tumor DNA (ctDNA) Monitoring During Adjuvant Capecitabine in Early Triple-negative Breast Cancer | 2026-11 |
| NCT06545331ExelixisStudy of XB010 in Subjects With Solid Tumors | 2026-11-23 |
| NCT02276443M.D. Anderson Cancer CenterMolecular Testing and Imaging in Improving Response in Patients With Stage I-III Triple-Negative Breast Cancer Receiving Chemotherapy MDACC Breast Moonshot Initiative | 2026-11-30 |
Among the 645 studies in Triple Negative Breast Neoplasms with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Dexamethasone · Drug: Famotidine · Drug: Diphenhydramine · Drug: Olanzapine · Drug: Paclitaxel · Drug: Carboplatin · Biological: Pembrolizumab · Drug: Doxorubicin · Drug: Cyclophosphamide
Dexamethasone will be administered intravenously at a dose of 10 mg prior to treatment of the KEYNOTE 522 regimen.
Also known as: Hemady
Famotidine will be administered intravenously at a dose of 20 mg prior to treatment of the KEYNOTE 522 regimen.
Also known as: Pepcid, Zantac 360
Diphenhydramine will be administered intravenously at a dose of 50 mg prior to treatment of the KEYNOTE 522 regimen.
Also known as: Benadryl
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.
Also known as: Zyprexa
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.
Also known as: 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.
Also known as: 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.
Also known as: 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.
Also known as: 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.
Also known as: KEYNOTE 522
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.
Time frame: During the 10 dexamethasone-free weekly paclitaxel/carboplatin containing infusions (total estimated time: 10 weeks)
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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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.
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.
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
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.
Time frame: On day 1 of cycles 1-8 (each cycle is 21 days) (total estimated time: 21 weeks)
Plan to share: No
Start is estimated for Nov 2026; primary completion for Feb 2028, 14 months later.
Of 220 non-industry phase 2 interventional studies under Triple Negative Breast Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 38 and three quarters within 99. This study's planned 14 months is below that.
Counting every sponsor, half of 255 studies reached it within 59 months; a quarter within 37 and three quarters within 94.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone
Triple Negative Breast Neoplasms →
Washington University School of Medicine →