Trial Outcomes & Findings for Incidence of Chemotherapy-Induced Nausea and Vomiting Associated With Docetaxel-Cyclophosphamide in Early Breast Cancer. (NCT NCT01298193)

Last Updated: 2023-03-07

Results Overview

Complete response is defined as no vomiting and no use of rescue treatment within the first cycle of Docetaxel-Cyclophosphamide for the treatment of early-stage breast cancer patients. A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are, by definition, separated by the absence of emesis and retching for at least 1 minute. The timing (date and time) of each vomiting episode will be recorded by the patient in each cycle diary at the time of occurrence. Assessments of efficacy will begin at the initiation of chemotherapy infusion (0 hours) until the morning of Day 6 (approximately 120 hours) after chemotherapy during 1-2 cycles.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

212 participants

Primary outcome timeframe

Up to 21 days after cycle 1 of chemotherapy treatment

Results posted on

2023-03-07

Participant Flow

The investigator registered all the selected patients before the start of the treatment. Once it was verified that the selection criteria were complied with, the investigator sent the previously completed randomization sheet by fax to Spanish Breast Cancer Research Group (GEICAM). Recruitment period: From May-2011 to 31-Jan-13.

Participant milestones

Participant milestones
Measure	Aprepitant Observational phase (first cycle): Day 0: Dexamethasone 8mg Day 1: 5-HydroxyTryptamine 3 (5-HT3) antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg. • Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3: Dexamethasone 16 mg. Patients that experiment emesis within the first cycle in spite of the administration of antiemetics goes to efficacy phase (Second cycle): Day 0: dexamethasone oral (8 mg Day 1: iv/oral\* 5-hydroxytryptamine 3 \[5-HT3\] + dexamethasone oral (4mg x 3) + aprepitant oral 125mg • Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Day 2 and 3: dexamethasone oral (4mg x 2) + oral aprepitant 80mg
Observational Phase (First Cycle) STARTED	212
Observational Phase (First Cycle) COMPLETED	185
Observational Phase (First Cycle) NOT COMPLETED	27
Efficacy Phase (Second Cycle) STARTED	24
Efficacy Phase (Second Cycle) COMPLETED	23
Efficacy Phase (Second Cycle) NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Aprepitant Observational phase (first cycle): Day 0: Dexamethasone 8mg Day 1: 5-HydroxyTryptamine 3 (5-HT3) antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg. • Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3: Dexamethasone 16 mg. Patients that experiment emesis within the first cycle in spite of the administration of antiemetics goes to efficacy phase (Second cycle): Day 0: dexamethasone oral (8 mg Day 1: iv/oral\* 5-hydroxytryptamine 3 \[5-HT3\] + dexamethasone oral (4mg x 3) + aprepitant oral 125mg • Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Day 2 and 3: dexamethasone oral (4mg x 2) + oral aprepitant 80mg
Observational Phase (First Cycle) Withdrawal by Subject	2
Observational Phase (First Cycle) Received TC at a different dose	16
Observational Phase (First Cycle) previous emetogenic chemotherapy	9
Efficacy Phase (Second Cycle) Death	1

Baseline Characteristics

Incidence of Chemotherapy-Induced Nausea and Vomiting Associated With Docetaxel-Cyclophosphamide in Early Breast Cancer.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aprepitant n=212 Participants Observational phase (first cycle): Day 0 (Dexamethasone 8mg) Day 1 (5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg). • Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg). Efficacy phase (second cycle): Day 0 (Dexamethasone 8mg) Day 1 (Aprepitant: 125 mg,5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2, Tropisetron: 5 mg, Dexamethasone 12 mg). Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Aprepitant: 1 capsule of 80 mg daily, Dexamethasone 8 mg). Aprepitant: Efficacy phase (second cycle)
Age, Continuous	57 years n=5 Participants
Sex: Female, Male Female	212 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	201 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	9 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants
Race/Ethnicity, Customized Arab	1 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) status ECOG 0	185 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) status ECOG 1	19 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) status Missing	8 Participants n=5 Participants
Menopausal Status Premenopausal	62 Participants n=5 Participants
Menopausal Status Postmenopausal	150 Participants n=5 Participants
Drink alcohol Yes	37 Participants n=5 Participants
Drink alcohol No	168 Participants n=5 Participants
Drink alcohol Not available	7 Participants n=5 Participants
Regularly dizziness Yes	22 Participants n=5 Participants
Regularly dizziness No	176 Participants n=5 Participants
Regularly dizziness Not available	14 Participants n=5 Participants
Morning nausea during pregnancy Yes	45 Participants n=5 Participants
Morning nausea during pregnancy No	142 Participants n=5 Participants
Morning nausea during pregnancy Not available	25 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 21 days after cycle 1 of chemotherapy treatment

Population: 27 patients were excluded from the main analysis: 16 received docetaxel and cyclophosphamide (TC) at a different dose from that in the protocol, 9 had received previous emetogenic chemotherapy and 2 withdrew study consent before receiving TC.

Outcome measures

Outcome measures
Measure	Observational Phase (First Cycle): n=185 Participants Observational phase (first cycle): Day 0 (Dexamethasone 8mg) Day 1 (5-hydroxytryptamine 3 \[5-HT3\] antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg). • Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).
Number of Participants With Complete Response (CR)	161 Participants

SECONDARY outcome

Timeframe: Up to cycle 2, and average of 6 weeks

Population: Of the 185 evaluable patients, 161 achieved CR, so who participated in this outcome were 24 patients who experienced non-complete response (NCR).

To evaluate in cycle 2 the efficacy of aprepitant (days 1, 2 and 3) as secondary prevention in patients without complete response in cycle 1. A vomiting episode is defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Distinct vomiting episodes are, by definition, separated by the absence of emesis and retching for at least 1 minute. The timing (date and time) of each vomiting episode will be recorded by the patient in each cycle diary at the time of occurrence. Assessments of efficacy will begin at the initiation of chemotherapy infusion (0 hours) until the morning of Day 6 (approximately 120 hours) after chemotherapy during 1-2 cycles.

Outcome measures

Outcome measures
Measure	Observational Phase (First Cycle): n=24 Participants Observational phase (first cycle): Day 0 (Dexamethasone 8mg) Day 1 (5-hydroxytryptamine 3 \[5-HT3\] antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg). • Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).
Number of Participants With Complete Response (CR) in Cycle 2 for Patient Without Complete Response in Cycle 1	12 Participants

SECONDARY outcome

Timeframe: Cycle 2, and average of 3 weeks

Population: Of the 185 evaluable patients, 161 achieved CR, so who participated in this outcome were 24 patients who experienced non-complete response (NCR).

Events are related to the primary end point, they were collected only in the diary during the period of diary data collection (Day 1 to the morning of Day 6) for the cycle 2, unless they meet the definition of a serious adverse event.

Outcome measures

Outcome measures
Measure	Observational Phase (First Cycle): n=24 Participants Observational phase (first cycle): Day 0 (Dexamethasone 8mg) Day 1 (5-hydroxytryptamine 3 \[5-HT3\] antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg). • Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).
Number of Participants With Treatment Related Adverse Events (AE) at Cycle 2	0 Participants

SECONDARY outcome

Timeframe: Up to day 6

Population: From 212 patients randomized, 27 were not evaluable patients. From the rest 185, 161 presented CR, and 24 a NCR.

To determine the incidence of Chemotherapy-Induced Nausea and Vomiting associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR). The FLIE questionnaire is a validated, patient-reported instrument to measure the impact of Chemotherapy-Induced Nausea and Vomiting on daily life. There are 18 items, each on a 7-point scale. Results are reported as a total score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of nausea or vomiting (better outcome) (Maximum 126, Minimum 18).

Outcome measures

Outcome measures
Measure	Observational Phase (First Cycle): n=185 Participants Observational phase (first cycle): Day 0 (Dexamethasone 8mg) Day 1 (5-hydroxytryptamine 3 \[5-HT3\] antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg). • Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).
Total Impact of Chemotherapy-Induced Nausea and Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1 Cycle 1 pre-chemotherapy NCR patients	43.7 score on a scale Interval 36.36 to 51.05
Total Impact of Chemotherapy-Induced Nausea and Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1 Cycle 1 post-chemotherapy NCR patients	59.2 score on a scale Interval 50.59 to 67.75
Total Impact of Chemotherapy-Induced Nausea and Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1 Cycle 1 pre-chemotherapy CR patients	42.5 score on a scale Interval 39.99 to 44.94
Total Impact of Chemotherapy-Induced Nausea and Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1 Cycle 1 post-chemotherapy CR patients	44.22 score on a scale Interval 42.04 to 46.79

SECONDARY outcome

Timeframe: Up to day 6

Population: From 212 patients randomized, 27 were not evaluable patients. From the rest 185, 161 presented CR, and 24 a NCR.

To determine the incidence of nausea associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR). The FLIE questionnaire is a validated, patient-reported instrument to measure the impact of Chemotherapy-Induced Nausea and vomiting on daily life. There are 9 nausea-related items, each on a 7-point scale. Results are reported as a nausea score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of nausea (better outcome) (Maximum 63, Minimum 9).

Outcome measures

Outcome measures
Measure	Observational Phase (First Cycle): n=185 Participants Observational phase (first cycle): Day 0 (Dexamethasone 8mg) Day 1 (5-hydroxytryptamine 3 \[5-HT3\] antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg). • Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).
Impact of Chemotherapy-Induced Nausea on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1 Cycle 1 pre-chemotherapy NCR patients	19.85 score on a scale Interval 16.23 to 23.46
Impact of Chemotherapy-Induced Nausea on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1 Cycle 1 post-chemotherapy NCR patients	31.73 score on a scale Interval 26.56 to 36.89
Impact of Chemotherapy-Induced Nausea on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1 Cycle 1 pre-chemotherapy CR patients	18.93 score on a scale Interval 17.76 to 20.1
Impact of Chemotherapy-Induced Nausea on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1 Cycle 1 post-chemotherapy CR patients	20.27 score on a scale Interval 19.12 to 21.42

SECONDARY outcome

Timeframe: Up to day 6

Population: From 212 patients randomized, 27 were not evaluable patients. From the rest 185, 161 presented CR, and 24 a NCR.

To determine the incidence of vomiting associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR). The FLIE questionnaire is a validated, patient-reported instrument to measure the impact of vomiting on daily life. There are 9 vomiting-related items, each on a 7-point scale. Results are reported as a vomiting score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of vomiting (better outcome) (Maximum 63, Minimum 9).

Outcome measures

Outcome measures
Measure	Observational Phase (First Cycle): n=185 Participants Observational phase (first cycle): Day 0 (Dexamethasone 8mg) Day 1 (5-hydroxytryptamine 3 \[5-HT3\] antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg). • Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).
Impact of Chemotherapy-Induced Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1 Cycle 1 pre-chemotherapy NCR patients	23.86 score on a scale Interval 19.84 to 27.89
Impact of Chemotherapy-Induced Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1 Cycle 1 post-chemotherapy NCR patients	27.46 score on a scale Interval 22.01 to 32.88
Impact of Chemotherapy-Induced Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1 Cycle 1 pre-chemotherapy CR patients	23.53 score on a scale Interval 22.07 to 25.0
Impact of Chemotherapy-Induced Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1 Cycle 1 post-chemotherapy CR patients	24.15 score on a scale Interval 22.76 to 25.54

SECONDARY outcome

Timeframe: Up to day 6

Population: During cycle 2, only 23 patients completed the FLIE questionnaire.

To determine the total incidence of Chemotherapy-Induced Nausea and Vomiting associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR). The FLIE questionnaire is a validated, patient-reported instrument to measure the impact of Chemotherapy-Induced Nausea and Vomiting on daily life. There are 18 items, each on a 7-point scale. Results are reported as a total score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of nausea or vomiting (better outcome) (Maximum 126, Minimum 18).

Outcome measures

Outcome measures
Measure	Observational Phase (First Cycle): n=23 Participants Observational phase (first cycle): Day 0 (Dexamethasone 8mg) Day 1 (5-hydroxytryptamine 3 \[5-HT3\] antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg). • Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).
Total Impact of Chemotherapy-Induced Nausea and Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2 Cycle 2 post-chemotherapy CR patients	47.7 score on a scale Interval 43.7 to 51.75
Total Impact of Chemotherapy-Induced Nausea and Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2 Cycle 2 pre-chemotherapy NCR patients	37.8 score on a scale Interval 25.74 to 49.86
Total Impact of Chemotherapy-Induced Nausea and Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2 Cycle 2 post-chemotherapy NCR patients	64.4 score on a scale Interval 52.07 to 76.64
Total Impact of Chemotherapy-Induced Nausea and Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2 Cycle 2 pre-chemotherapy CR patients	43.28 score on a scale Interval 30.2 to 56.36

SECONDARY outcome

Timeframe: Up to day 6

Population: During cycle 2, only 23 patients completed the FLIE questionnaire.

To determine the incidence of Nausea associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR). The FLIE questionnaire is a validated, patient-reported instrument to measure the impact of Nausea on daily life. There are 9 items, each on a 7-point scale. Results are reported as a nausea score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of nausea (better outcome) (Maximum 63, Minimum 9).

Outcome measures

Outcome measures
Measure	Observational Phase (First Cycle): n=23 Participants Observational phase (first cycle): Day 0 (Dexamethasone 8mg) Day 1 (5-hydroxytryptamine 3 \[5-HT3\] antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg). • Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).
Impact of Chemotherapy-Induced Nausea on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2 Cycle 2 pre-chemotherapy NCR patients	17.71 score on a scale Interval 11.07 to 24.35
Impact of Chemotherapy-Induced Nausea on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2 Cycle 2 post-chemotherapy NCR patients	36.16 score on a scale Interval 28.26 to 44.07
Impact of Chemotherapy-Induced Nausea on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2 Cycle 2 pre-chemotherapy CR patients	19.57 score on a scale Interval 13.66 to 25.48
Impact of Chemotherapy-Induced Nausea on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2 Cycle 2 post-chemotherapy CR patients	24.30 score on a scale Interval 20.35 to 28.25

SECONDARY outcome

Timeframe: Up to day 6

Population: During cycle 2, only 23 patients completed the FLIE questionnaire.

To determine the incidence of vomiting associated with the Docetaxel-Cyclophosphamide regimen in early breast cancer patients, a Functional Living Index-Emesis (FLIE) questionnaire was collected on treatment Day 1 (prior to initiation of chemotherapy) and Day 6, which referenced the entire treatment period since the initiation of chemotherapy for non clinical responders (NCR) against clinical responders (CR). The FLIE questionnaire is a validated, patient-reported instrument to measure the impact of vomiting on daily life. There are 9 items, each on a 7-point scale. Results are reported as a vomiting score. For the purposes of this study, higher scores indicate less impairment on daily life as a result of vomiting (better outcome) (Maximum 63, Minimum 9).

Outcome measures

Outcome measures
Measure	Observational Phase (First Cycle): n=23 Participants Observational phase (first cycle): Day 0 (Dexamethasone 8mg) Day 1 (5-hydroxytryptamine 3 \[5-HT3\] antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg). • Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).
Impact of Chemotherapy-Induced Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2 Cycle 2 pre-chemotherapy NCR patients	20.09 score on a scale Interval 12.82 to 27.36
Impact of Chemotherapy-Induced Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2 Cycle 2 post-chemotherapy NCR patients	28.19 score on a scale Interval 21.91 to 34.47
Impact of Chemotherapy-Induced Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2 Cycle 2 pre-chemotherapy CR patients	23.71 score on a scale Interval 16.4 to 31.02
Impact of Chemotherapy-Induced Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2 Cycle 2 post-chemotherapy CR patients	23.43 score on a scale Interval 17.55 to 29.3

Adverse Events

Observational Phase (First Cycle):

Serious events: 31 serious events

Other events: 47 other events

Deaths: 1 deaths

Efficacy Phase (Second Cycle):

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Observational Phase (First Cycle): n=185 participants at risk Day 0 (Dexamethasone 8mg) Day 1 (5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg). • Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).	Efficacy Phase (Second Cycle): n=24 participants at risk Day 0 (Dexamethasone 8mg) Day 1 (Aprepitant: 125 mg,5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2, Tropisetron: 5 mg, Dexamethasone 12 mg). Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Aprepitant: 1 capsule of 80 mg daily, Dexamethasone 8 mg).
Blood and lymphatic system disorders Anemic Shock	0.54% 1/185 • Number of events 1 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.	0.00% 0/24 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.
Blood and lymphatic system disorders Febrile Neutropenia	1.1% 2/185 • Number of events 2 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.	0.00% 0/24 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.54% 1/185 • Number of events 1 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.	0.00% 0/24 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.
Gastrointestinal disorders Colon Diverticulitis	0.54% 1/185 • Number of events 1 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.	0.00% 0/24 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.
Gastrointestinal disorders Vomiting	0.54% 1/185 • Number of events 1 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.	0.00% 0/24 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.
Blood and lymphatic system disorders Febrile neutropenia	1.6% 3/185 • Number of events 3 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.	0.00% 0/24 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.
Gastrointestinal disorders Lower Gastrointestinal Bleeding	0.54% 1/185 • Number of events 1 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.	0.00% 0/24 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.
Gastrointestinal disorders Mucositis	0.54% 1/185 • Number of events 1 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.	0.00% 0/24 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.
Skin and subcutaneous tissue disorders Erythema with pruritus and skin lessions	0.54% 1/185 • Number of events 1 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.	0.00% 0/24 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.
Gastrointestinal disorders Enterocollitis	0.54% 1/185 • Number of events 1 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.	0.00% 0/24 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.
Blood and lymphatic system disorders Neutrophil Count Decreased	1.1% 2/185 • Number of events 2 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.	0.00% 0/24 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.

Other adverse events

Other adverse events
Measure	Observational Phase (First Cycle): n=185 participants at risk Day 0 (Dexamethasone 8mg) Day 1 (5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2,Tropisetron: 5 mg, Dexamethasone 24 mg). • Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Dexamethasone 16 mg).	Efficacy Phase (Second Cycle): n=24 participants at risk Day 0 (Dexamethasone 8mg) Day 1 (Aprepitant: 125 mg,5-HT3 antagonist, Ondansetron: 8 mg x2, Granisetron: 1mg x2, Tropisetron: 5 mg, Dexamethasone 12 mg). Chemotherapy: Docetaxel 75mg/m2 and Cyclophosphamide 600mg/m2 Days 2 and 3 (Aprepitant: 1 capsule of 80 mg daily, Dexamethasone 8 mg).
Gastrointestinal disorders Nausea	7.6% 14/185 • Number of events 14 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.	50.0% 12/24 • Number of events 12 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.
Gastrointestinal disorders Vomiting	7.0% 13/185 • Number of events 13 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.	12.5% 3/24 • Number of events 3 • Through study treatment, average of 6 weeks This section includes related and no related Adverse Events and Serious Adverse Events. There are not adverse events related to aprepitant treatment in cycle 2.

Additional Information

Scientific Director / Medical Lead / Project Manager

Spanish Breast Cancer Research Group

Phone: +34916592870

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place