Trial Outcomes & Findings for Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel (NCT NCT04862585)
NCT ID: NCT04862585
Last Updated: 2025-08-20
Results Overview
The proportion of patients having infusion HSR of grade 2 or greater requiring parental treatment (rescue medications) will be estimated along with a 95% confidence interval. The difference in proportions of patients with grade 2 or greater infusion HSR needing rescue medication will be estimated along with a 95% confidence interval using the Z-test of normal approximations of the binomial distributions. As a sensitivity analysis, will repeat the analysis including patients assigned to the discontinuation arm but decided to restart pre-medications and patients assigned to the continuation arm but demanded to have premedications discontinued as having experienced HSR.
COMPLETED
PHASE2/PHASE3
130 participants
Up to 2 years and 8 months
2025-08-20
Participant Flow
130 subjects enrolled. 32 not randomized (29 experienced HSR in 1st or 2nd dose of Taxol, 1 ineligible, 2 withdrew). 98 randomized: 50 randomized to continue premeds (4 withdrew after randomization) total of 46 evaluable. 48 randomized to stop premeds (5 withdrew after randomization) total of 43 evaluable.
Participant milestones
| Measure |
Arm I (Paclitaxel, Pre-medications)
Patients continue on pre-medications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel.
Cimetidine: Given IV and/or PO
Dexamethasone: Given IV and/or PO
Diphenhydramine: Given IV and/or PO
Famotidine: Given IV and/or PO
Paclitaxel: Weekly or every 14 day dosing
Quality-of-Life Assessment: Ancillary studies
Ranitidine: Given IV and/or PO
|
Arm II (Paclitaxel)
Patients discontinue premedications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel, unless patient develops a subsequent infusion HSR.
Paclitaxel: Weekly or every 14 day dosing
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
48
|
|
Overall Study
COMPLETED
|
46
|
43
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
Arm I (Paclitaxel, Pre-medications)
Patients continue on pre-medications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel.
Cimetidine: Given IV and/or PO
Dexamethasone: Given IV and/or PO
Diphenhydramine: Given IV and/or PO
Famotidine: Given IV and/or PO
Paclitaxel: Weekly or every 14 day dosing
Quality-of-Life Assessment: Ancillary studies
Ranitidine: Given IV and/or PO
|
Arm II (Paclitaxel)
Patients discontinue premedications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel, unless patient develops a subsequent infusion HSR.
Paclitaxel: Weekly or every 14 day dosing
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
two subjects withdrew due to perceived side effects of premedications
|
2
|
0
|
|
Overall Study
five subjects withdrew due to what they considered to be an unfavorable randomization assignment
|
2
|
3
|
|
Overall Study
one subject discontinued paclitaxel due to toxicity
|
0
|
1
|
|
Overall Study
one withdrew without providing a reason
|
0
|
1
|
Baseline Characteristics
Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel
Baseline characteristics by cohort
| Measure |
Arm I (Paclitaxel, Pre-medications)
n=46 Participants
Patients continue on pre-medications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel.
Cimetidine: Given IV and/or PO
Dexamethasone: Given IV and/or PO
Diphenhydramine: Given IV and/or PO
Famotidine: Given IV and/or PO
Paclitaxel: Weekly or every 14 day dosing
Quality-of-Life Assessment: Ancillary studies
Ranitidine: Given IV and/or PO
|
Arm II (Paclitaxel)
n=43 Participants
Patients discontinue premedications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel, unless patient develops a subsequent infusion HSR.
Paclitaxel: Weekly or every 14 day dosing
Quality-of-Life Assessment: Ancillary studies
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
46 participants
n=5 Participants
|
43 participants
n=7 Participants
|
89 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 2 years and 8 monthsThe proportion of patients having infusion HSR of grade 2 or greater requiring parental treatment (rescue medications) will be estimated along with a 95% confidence interval. The difference in proportions of patients with grade 2 or greater infusion HSR needing rescue medication will be estimated along with a 95% confidence interval using the Z-test of normal approximations of the binomial distributions. As a sensitivity analysis, will repeat the analysis including patients assigned to the discontinuation arm but decided to restart pre-medications and patients assigned to the continuation arm but demanded to have premedications discontinued as having experienced HSR.
Outcome measures
| Measure |
Arm I (Paclitaxel, Pre-medications)
n=46 Participants
Patients continue on pre-medications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel.
Cimetidine: Given IV and/or PO
Dexamethasone: Given IV and/or PO
Diphenhydramine: Given IV and/or PO
Famotidine: Given IV and/or PO
Paclitaxel: Weekly or every 14 day dosing
Quality-of-Life Assessment: Ancillary studies
Ranitidine: Given IV and/or PO
|
Arm II (Paclitaxel)
n=43 Participants
Patients discontinue premedications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel, unless patient develops a subsequent infusion HSR.
Paclitaxel: Weekly or every 14 day dosing
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Proportion of Patients With Grade 2 or Greater Reactions That Require Parenteral Rescue Medications to Treat an Infusion Hypersensitivity Reaction (HSR) After the First 2 Doses of Paclitaxel With or Without Continued Premedication Dosing
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years and 8 monthsWill determine whether an abbreviated pre-medication regimen results in an improvement in patient-reported quality of life, as measured by an 11-point numerical analog scale (scores range from 0-10 with higher values representing a worse QoL). Both "undesirable appetite increase" and "reported rash" will be rated on this 11-point scale from 0 to 10 with higher values representing a worse undesirable appetite or a worse rash. The "worst reported undesirable appetite increase" and "worst reported rash" scores representing the highest mean score reported at an individual time point for each arm, will be summarized. In addition the change from baseline will be summarized by mean separately by treatment arm. Data will be captured every day, for one week after each dose of chemotherapy.
Outcome measures
| Measure |
Arm I (Paclitaxel, Pre-medications)
n=46 Participants
Patients continue on pre-medications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel.
Cimetidine: Given IV and/or PO
Dexamethasone: Given IV and/or PO
Diphenhydramine: Given IV and/or PO
Famotidine: Given IV and/or PO
Paclitaxel: Weekly or every 14 day dosing
Quality-of-Life Assessment: Ancillary studies
Ranitidine: Given IV and/or PO
|
Arm II (Paclitaxel)
n=43 Participants
Patients discontinue premedications (dexamethasone, diphenhydramine, famotidine/ranitidine/cimetidine) with all future doses of paclitaxel, unless patient develops a subsequent infusion HSR.
Paclitaxel: Weekly or every 14 day dosing
Quality-of-Life Assessment: Ancillary studies
|
|---|---|---|
|
Correlation Between Abbreviated Premedication Regimen Results to Quality of Life (QoL)
Worst reported undesirable appetite increase
|
2.5 score on a scale
Interval 1.77 to 3.23
|
1 score on a scale
Interval 0.54 to 1.46
|
|
Correlation Between Abbreviated Premedication Regimen Results to Quality of Life (QoL)
Worst reported rash
|
3.3 score on a scale
Interval 2.58 to 4.12
|
2.3 score on a scale
Interval 1.48 to 3.13
|
|
Correlation Between Abbreviated Premedication Regimen Results to Quality of Life (QoL)
Change in undesirable appetite increase from baseline
|
1.7 score on a scale
Interval 1.08 to 2.36
|
0.5 score on a scale
Interval 0.15 to 0.8
|
|
Correlation Between Abbreviated Premedication Regimen Results to Quality of Life (QoL)
Change in reported rash from baseline
|
2.9 score on a scale
Interval 2.11 to 3.72
|
1.9 score on a scale
Interval 1.13 to 2.59
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 6 yearsEach symptom will be summarized by median (range) at each time point by treatment arm and the weekly average will be compared between arms using the Wilcoxon rank sum test.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 6 yearsThe frequency and percentages of patients who, after discontinuing pre-medications, request that the pre-medications be resumed to ameliorate side-effects that the patient thinks have worsened since pre-medications were stopped (i.e. nausea, rash, arthralgia) will be summarized.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 6 yearsWeight changes over time will be summarized at each time point using mean (standard deviation) and plotted by treatment arm. Weight change from baseline to 10 weeks post-randomization will be compared between arms that receive weekly paclitaxel using a t-test of two independent samples.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 6 yearsWill report the impact of patient self-reported allergies, prior to starting paclitaxel (2 or more versus 3 or less), on the incidence of infusion HSR and rescue medication usage. Frequency of patient self-reported allergies (2 or more versus less) on the incidence of infusion HSR and rescue medication usage will be tabulated.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 6 yearsThe rates of rescue medication by arms will be estimated by race/ethnicity group to explore whether there is a differential effect from stopping hypersensitivity reaction by race/ethnicity.
Outcome measures
Outcome data not reported
Adverse Events
Arm I (Paclitaxel, Pre-medications)
Arm II (Paclitaxel)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place