A Phase 3 interventional study of Dexamethasone and Laboratory Biomarker Analysis in Breast Carcinoma, sponsored by University of Rochester NCORP Research Base. Completed at 18 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by University of Rochester NCORP Research Base · Phase 3, Interventional, and Supportive care
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Among 14 studies testing dexamethasone in Breast Neoplasms — 5 open to participants now, 5 under way, 1 of them phase 3. Dexamethasone · Breast Neoplasms.
Among the 14 studies testing dexamethasone in Breast Neoplasms, this one has the largest enrollment, is one of 2 that started in 2018, is one of 4 in phase 3, and was the 9th registered.
14,832 studies on the registry are indexed under Breast Neoplasms; 3,320 are open to participants now.
Browse Breast Neoplasms studies →5 of the 14 studies testing dexamethasone in Breast Neoplasms are open now, in 1 country. Recruiting first, the newest first:
Brown University · Sites in United States
Ages 18+
Mario Negri Institute for Pharmacological Research
Ages 18+
Washington University School of Medicine · Sites in United States
Ages 18+
The Netherlands Cancer Institute
Ages 18+ · Women only
Al-Azhar University
Ages 20–60 · Women only
By country, each count listing its studies:
Dexamethasone: first FDA approval 1958 (DECADRON), first EMA approval 2010. What it is approved for, and how studies give it, is on its page →
Of the 2,399 Breast Neoplasms studies recruiting now, 1,570 (65%) set no upper age limit and 592 (25%) stop at 75 or younger; 103 take children under 18; 215 take healthy volunteers.
This study: 18 Years and older · female · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
14 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,363 is above the median of 72 across 10,903 interventional studies indexed under Breast Neoplasms.
Median enrollment 80 across the 14 interventional studies. Of the 8 that completed or were terminated, 3 (38%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 14 has an industry lead sponsor. The 10 most frequent:
University of Rochester NCORP Research Base is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
University of Rochester NCORP Research Base has 2 studies filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
1 of the studies testing dexamethasone in Breast Neoplasms that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06974604Brown UniversityPreventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM | 2027-05-31 |
Add it to your calendar (.ics) → With an account.
Among the 14 studies testing dexamethasone in Breast Neoplasms, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This randomized phase III trial studies how well netupitant/palonosetron hydrochloride and dexamethasone with prochlorperazine or olanzapine work compared to netupitant/palonosetron hydrochloride and dexamethasone in improving chemotherapy-induced nausea and vomiting in patients with breast cancer. Antiemetic drugs, such as prochlorperazine and olanzapine, may help lessen nausea and vomiting in patients with breast cancer treated with chemotherapy.
PRIMARY OBJECTIVES:
I. To determine if control of nausea at cycle 2 in participants who experienced chemotherapy-induced nausea and vomiting (CINV) at cycle 1 is improved by the addition of either prochlorperazine or olanzapine to the control arm of netupitant, palonosetron and dexamethasone.
SECONDARY OBJECTIVES:
I. To determine if olanzapine is more effective than prochlorperazine in controlling nausea at cycle 2 in participants who experienced CINV at cycle 1 when used in combination with netupitant, palonosetron and dexamethasone.
II. To determine if control of vomiting at cycle 2 in patients who experienced CINV at cycle 1 is improved by the addition of either prochlorperazine or olanzapine to the control arm of netupitant, palonosetron and dexamethasone.
III. To determine if olanzapine is more effective than prochlorperazine in controlling vomiting at cycle 2 in participants who experienced CINV at cycle 1 when used in combination with netupitant, palonosetron and dexamethasone.
TERTIARY OBJECTIVES:
I. To create an empirically-based algorithm predicting nausea from breast cancer chemotherapy regimens that takes into account not only state-of-the-art anti-emetic regimens but also participant factors such as age, race, education, ethnicity, quality of life (QOL), alcohol consumption, susceptibility to nausea, expectancy, anxiety, level of nausea on the day prior to treatment, and prior history of nausea.
II. To compare the effects of the interventions on QOL, as assessed by the Functional Assessment of Cancer Therapy- General (FACT-G), by following the same procedures described under the primary aim and the first secondary aim, using change in the FACT-G scores as the response.
III. To provide preliminary data on the frequency and severity of sleep disturbance, fatigue, anxiety, and dizziness, across treatment conditions.
IV. To provide preliminary data on biological factors (e.g. glutathione [GSH] recycling, genetic markers) that may help identify a subgroup of patients at high risk for development of cancer-related or treatment-related side effects, or response to treatment.
OUTLINE:
PART I: Patients receive 1 cycle of standard of care chemotherapy.
PART II: Patients with a nausea score >= 3 at least once on the diary at cycle 1 chemotherapy are randomized into 1 of 3 groups at cycle 2.
GROUP I: Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride orally (PO) on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy every 8 hours (Q8H) on days 1-4.
GROUP II: Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
GROUP III: Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
After completion of study treatment, patients are followed up for 30 days.
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.
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.
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.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
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.
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.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Within 1 hour prior to chemotherapy, patients receive netupitant/palonosetron hydrochloride PO on day 1. Within 30 minutes prior to chemotherapy, patients also receive dexamethasone PO on days 1-4. Patients also receive placebo PO with chemotherapy Q8H on days 1-4.
Drug: Dexamethasone · Other: Laboratory Biomarker Analysis · Drug: Netupitant/Palonosetron Hydrochloride · Other: Placebo · Other: Quality-of-Life Assessment
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive prochlorperazine PO Q8H and placebo PO with chemotherapy on days 1-4.
Drug: Dexamethasone · Other: Laboratory Biomarker Analysis · Drug: Netupitant/Palonosetron Hydrochloride · Other: Placebo · Drug: Prochlorperazine · Other: Quality-of-Life Assessment
Patients receive netupitant/palonosetron hydrochloride and dexamethasone as in Group I. Patients also receive olanzapine PO and placebo PO Q8H with chemotherapy on days 1-4.
Drug: Dexamethasone · Other: Laboratory Biomarker Analysis · Drug: Netupitant/Palonosetron Hydrochloride · Drug: Olanzapine · Other: Placebo · Other: Quality-of-Life Assessment
Given PO
Also known as: Aacidexam, Adexone, Aknichthol Dexa, Alba-Dex, Alin, Alin Depot, Alin Oftalmico, Amplidermis, Anemul mono, Auricularum, Auxiloson, Baycuten, Baycuten N, Cortidexason, Cortisumman, Decacort, Decadrol, Decadron, Decalix, Decameth, Decasone R.p., Dectancyl, Dekacort, Deltafluorene, Deronil, Desamethasone, Desameton, Dexa-Mamallet, Dexa-Rhinosan, Dexa-Scheroson, Dexa-sine, Dexacortal, Dexacortin, Dexafarma, Dexafluorene, Dexalocal, Dexamecortin, Dexameth, Dexamethasonum, Dexamonozon, Dexapos, Dexinoral, Dexone, Dinormon, Fluorodelta, Fortecortin, Gammacorten, Hexadecadrol, Hexadrol, Lokalison-F, Loverine, Methylfluorprednisolone, Millicorten, Mymethasone, Orgadrone, Spersadex, Visumetazone
Correlative studies
Given PO
Also known as: Akynzeo
Given PO
Also known as: LY 170053, Zydis, Zyprexa, Zyprexa Zydis
Given PO
Also known as: placebo therapy, PLCB, sham therapy
Given PO
Also known as: RP 6140, SKF-4657
Ancillary studies
Also known as: Quality of Life Assessment
Average Nausea Defined as the Average [ MAXIMUM ] Nausea Rating Across 15 Assessment Points at Cycle 1 and 16 Assessment Points at Cycle 2 (Comparing Prochlorperazine or Olanzapine to Control Arm)
Will be measured on a 7-point scale ("1: not at all nauseated", "4: moderately nauseated", "7: extremely nauseated"). Higher score is a worse outcome. This is averaged over 15 assessment points for Cycle 1 (Day 1 measured at afternoon, evening and night and Days 2 through 4 measured at morning, afternoon, evening and night). This is averaged over 16 assessment points for Cycle 2 (Days 1 through 4 measured at morning, afternoon, evening and night).
Time frame: Nausea measured at Cycle 1 Chemotherapy (15 time points which is Days 1,2,3,4) and also measured at Cycle 2 Chemotherapy (16 time points which is Days 1,2,3,4)
Average Nausea Defined as the [AVERAGE] Nausea Rating Across 15 Assessment Points at Cycle 1 and 16 Assessment Points at Cycle 2 (Comparing Prochlorperazine or Olanzapine to Control Arm)
Will be measured on a 7-point scale ("1: not at all nauseated", "4: moderately nauseated", "7: extremely nauseated"). Higher score is a worse outcome. This is averaged over 15 assessment points for Cycle 1 (Day 1 measured at afternoon, evening and night and Days 2 through 4 measured at morning, afternoon, evening and night). This is averaged over 16 assessment points for Cycle 2 (Days 1 through 4 measured at morning, afternoon, evening and night).
Time frame: Nausea measured at Cycle 1 Chemotherapy (15 time points which is Days 1,2,3,4) and also measured at Cycle 2 Chemotherapy (16 time points which is Days 1,2,3,4)
The Secondary Outcome Variable Will be [ MAXIMUM ] Nausea (Measured on a 7-point Scale Anchored by ("1:Not at All Nauseated" and 7:"Extremely Nauseated"). Difference of Average Nausea Between Control and Experimental Arms Will be Calculated and Compared.
Will be measured on a 7-point scale anchored by "1:not at all nauseated" and "7:extremely nauseated". Higher score is a worse outcome. This is averaged over 15 assessment points for Cycle 1 and 16 assessment points for Cycle 2. This will be assessed by estimating the contrast D = (3 - 1) - (2 - 1), where 3 is the Arm 3 mean, 2 is the Arm 2 mean, and 1 is the Control mean.
Time frame: Nausea measured at Cycle 1 Chemotherapy (15 time points which is Days 1,2,3,4) and also measured at Cycle 2 Chemotherapy (16 time points which is Days 1,2,3,4)
Vomiting (Yes/No) at Cycle 2 in Participants Who Experienced CINV at Cycle 1.
The response variable will be Any VOMITING (yes/no) after Cycle 2 Chemotherapy, treatment arm as the main factor, and Any Vomiting after Cycle 1 as a covariate. Estimation will be performed using maximum likelihood assuming a binomial distribution and logit link. The same group of contrasts described in the Primary Aim analysis will be estimated and tested, with a significance level of 0.025 to adjust for multiple tests.
Time frame: Vomiting measured at Cycle 1 Chemotherapy (Yes/No on Days 1,2,3,4) and also measured at Cycle 2 Chemotherapy (Yes/No on Days 1,2,3,4)
Regimens: Chemotherapy Regimens at Cycle 2
Grouping of Chemotherapy Regimens at Cycle 2
Time frame: Cycle 2 Chemotherapy
Emetogenic Potential
Emetogenic Potential: The percentage of risk of vomiting based on given chemotherapy agents. Reference: https://pubmed.ncbi.nlm.nih.gov/38129530/
Time frame: Cycle 2 Chemotherapy
Vomiting at Cycle 1 of Chemotherapy
Record of any vomiting (Yes/No) during Cycle 1 of Chemotherapy on Days 1, 2, 3, 4
Time frame: Cycle 1 Chemotherapy
Vomiting at Cycle 2 of Chemotherapy
Record of any vomiting (Yes/No) during Cycle 2 of Chemotherapy on Days 1, 2, 3, 4
Time frame: Cycle 2 Chemotherapy
| Milestone | Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) |
|---|---|---|---|
| Started | 92 | 113 | 112 |
| Completed | 91 | 110 | 109 |
| Not completed | 1 | 3 | 3 |
| Milestone | Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) |
|---|---|---|---|
| Started | 91 | 110 | 109 |
| Completed | 85 | 108 | 100 |
| Not completed | 6 | 2 | 9 |
Will be measured on a 7-point scale ("1: not at all nauseated", "4: moderately nauseated", "7: extremely nauseated"). Higher score is a worse outcome. This is averaged over 15 assessment points for Cycle 1 (Day 1 measured at afternoon, evening and night and Days 2 through 4 measured at morning, afternoon, evening and night). This is averaged over 16 assessment points for Cycle 2 (Days 1 through 4 measured at morning, afternoon, evening and night).
| units on a scale | Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) |
|---|---|---|---|
| Cycle 1 | 4.51 ± 0.155 | 4.70 ± 0.141 | 4.93 ± 0.141 |
| Cycle 2 | 3.22 ± 0.164 | 2.68 ± 0.147 | 2.37 ± 0.152 |
Will be measured on a 7-point scale ("1: not at all nauseated", "4: moderately nauseated", "7: extremely nauseated"). Higher score is a worse outcome. This is averaged over 15 assessment points for Cycle 1 (Day 1 measured at afternoon, evening and night and Days 2 through 4 measured at morning, afternoon, evening and night). This is averaged over 16 assessment points for Cycle 2 (Days 1 through 4 measured at morning, afternoon, evening and night).
| units on a scale | Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) |
|---|---|---|---|
| Cycle 1 | 2.40 ± 0.120 | 2.58 ± 0.109 | 2.50 ± 0.109 |
| Cycle 2 | 1.90 ± 0.101 | 1.62 ± 0.090 | 1.45 ± 0.093 |
Will be measured on a 7-point scale anchored by "1:not at all nauseated" and "7:extremely nauseated". Higher score is a worse outcome. This is averaged over 15 assessment points for Cycle 1 and 16 assessment points for Cycle 2. This will be assessed by estimating the contrast D = (3 - 1) - (2 - 1), where 3 is the Arm 3 mean, 2 is the Arm 2 mean, and 1 is the Control mean.
| units on a scale | Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) |
|---|---|---|---|
| Cycle 1 | 4.51 ± 0.155 | 4.70 ± 0.141 | 4.93 ± 0.141 |
| Cycle 2 | 3.22 ± 0.164 | 2.68 ± 0.147 | 2.37 ± 0.152 |
The response variable will be Any VOMITING (yes/no) after Cycle 2 Chemotherapy, treatment arm as the main factor, and Any Vomiting after Cycle 1 as a covariate. Estimation will be performed using maximum likelihood assuming a binomial distribution and logit link. The same group of contrasts described in the Primary Aim analysis will be estimated and tested, with a significance level of 0.025 to adjust for multiple tests.
| Participants | Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) |
|---|---|---|---|
| Yes | 7 | 4 | 2 |
| No | 79 | 103 | 98 |
| Unknown | 5 | 3 | 9 |
Grouping of Chemotherapy Regimens at Cycle 2
| Participants | Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) |
|---|---|---|---|
| Anthracycline based | 54 | 68 | 55 |
| Taxane based | 19 | 22 | 22 |
| Platinum based | 14 | 16 | 27 |
| Others | 0 | 2 | 3 |
| Unknown | 4 | 2 | 2 |
Emetogenic Potential: The percentage of risk of vomiting based on given chemotherapy agents. Reference: https://pubmed.ncbi.nlm.nih.gov/38129530/
| Participants | Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) |
|---|---|---|---|
| High ( >=90 % risk of vomiting ) | 54 | 68 | 55 |
| Moderate ( 30 - 90 % risk of vomiting ) | 33 | 40 | 52 |
| Unknown | 4 | 2 | 2 |
Record of any vomiting (Yes/No) during Cycle 1 of Chemotherapy on Days 1, 2, 3, 4
| Participants | Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) |
|---|---|---|---|
| Yes | 12 | 18 | 19 |
| No | 79 | 92 | 90 |
Record of any vomiting (Yes/No) during Cycle 2 of Chemotherapy on Days 1, 2, 3, 4
| Participants | Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) |
|---|---|---|---|
| Yes | 7 | 4 | 2 |
| No | 79 | 103 | 98 |
| Unknown | 5 | 3 | 9 |
Collected over The time frame for the Adverse Events is within 4 days of when drugs were given at Cycle 2.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | 0/91 (0%) | 1/91 (1.1%) | 10/91 (11%) |
| Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | 0/110 (0%) | 3/110 (2.7%) | 19/110 (17.3%) |
| Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) | 0/109 (0%) | 3/109 (2.8%) | 14/109 (12.8%) |
| Event | Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) |
|---|---|---|---|
| FatigueGeneral disorders | 0/91 | 0/110 | 2/109 |
| DizzinessNervous system disorders | 1/91 | 0/110 | 0/109 |
| NauseaGastrointestinal disorders | 1/91 | 0/110 | 0/109 |
| AnorexiaMetabolism and nutrition disorders | 0/91 | 0/110 | 1/109 |
| Mucositis OralGastrointestinal disorders | 0/91 | 0/110 | 1/109 |
| HeadacheNervous system disorders | 0/91 | 0/110 | 1/109 |
| Musculoskeletal and connective tissue disorders, other specifyMusculoskeletal and connective tissue disorders | 0/91 | 1/110 | 0/109 |
| PainGeneral disorders | 0/91 | 1/110 | 0/109 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 0/91 | 1/110 | 0/109 |
| Event | Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) |
|---|---|---|---|
| FatigueGeneral disorders | 3/91 | 10/110 | 6/109 |
| DizzinessNervous system disorders | 1/91 | 0/110 | 5/109 |
| InsomniaPsychiatric disorders | 1/91 | 4/110 | 1/109 |
| NauseaGastrointestinal disorders | 3/91 | 1/110 | 1/109 |
| ConstipationGastrointestinal disorders | 0/91 | 2/110 | 2/109 |
| HyperglycemiaMetabolism and nutrition disorders | 0/91 | 1/110 | 2/109 |
| AkathisiaNervous system disorders | 0/91 | 2/110 | 0/109 |
| HeadacheInvestigations | 1/91 | 0/110 | 0/109 |
| Abdominal PainGastrointestinal disorders | 1/91 | 0/110 | 0/109 |
| DyspepsiaGastrointestinal disorders | 1/91 | 1/110 | 1/109 |
| Age, Continuous(years) | Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) | Total |
|---|---|---|---|---|
| Mean | 52.0 ± 11.3 | 50.0 ± 11.5 | 50.2 ± 11.8 | 50.7 ± 11.5 |
| Sex: Female, Male(Participants) | Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) | Total |
|---|---|---|---|---|
| Female | 91 | 110 | 109 | 310 |
| Male | 0 | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) | Total |
|---|---|---|---|---|
| Hispanic or Latino | 4 | 4 | 5 | 13 |
| Not Hispanic or Latino | 79 | 102 | 99 | 280 |
| Unknown or Not Reported | 8 | 4 | 5 | 17 |
| Race (NIH/OMB)(Participants) | Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 | 2 |
| Asian | 2 | 7 | 6 | 15 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 9 | 14 | 15 | 38 |
| White | 75 | 86 | 84 | 245 |
| More than one race | 2 | 2 | 1 | 5 |
| Unknown or Not Reported | 3 | 0 | 2 | 5 |
| Marital Status(Participants) | Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) | Total |
|---|---|---|---|---|
| Married / Long Term | 66 | 86 | 81 | 233 |
| Divorced | 8 | 7 | 3 | 18 |
| Separated | 4 | 2 | 6 | 12 |
| Single | 10 | 11 | 15 | 36 |
| Widowed | 3 | 4 | 4 | 11 |
| Education(Participants) | Group I (Netupitant/Palonosetron Hydrochloride, Dexamethasone | Group II (Net/Pal Hydro, Dexa, Prochlorperazine, Placebo) | Group III (Net/Pal Hydro, Dexa, Olanzapine, Placebo) | Total |
|---|---|---|---|---|
| College or Grad School | 20 | 27 | 23 | 70 |
| High School or Less | 71 | 83 | 86 | 240 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Apr 2018 to primary completion in Apr 2024, 71 months.
Results were first posted in Sep 2025, 1 year 5 months after primary completion.
Of 328 non-industry phase 3 interventional studies under Breast Neoplasms, half reached primary completion within 79 months of starting (the median), counting those still running; a quarter within 50 and three quarters within 127. This study's 71 months is below that.
Counting every sponsor, half of 600 studies reached it within 59 months; a quarter within 36 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone
University of Rochester NCORP Research Base