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).
If not complete response:
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).

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)

Aprepitant

Sex: Female, Male

Race/Ethnicity, Customized

ECOG score runs from 0 to 5, with 0 denoting perfect health and 5 death. 0 - Asymptomatic
- Symptomatic but completely ambulatory
- Symptomatic, <50% in bed during the day
- Symptomatic, >50% in bed, but not bedbound
- Bedbound
- Death

Eastern Cooperative Oncology Group (ECOG) status

Menopausal Status

Drink alcohol

Regularly dizziness

Morning nausea during pregnancy

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.

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).

Observational Phase (First Cycle):

Number of Participants With Complete Response (CR)

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.

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

Aprepitant NCR

Number of Participants With Complete Response (CR) in Cycle 2 for Patient Without Complete Response in Cycle 1

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.

Number of Participants With Treatment Related Adverse Events (AE) at Cycle 2

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).

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

Total Impact of Chemotherapy-Induced Nausea and Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1

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).

Impact of Chemotherapy-Induced Nausea on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1

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).

Impact of Chemotherapy-Induced Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 1

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).

Total Impact of Chemotherapy-Induced Nausea and Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2

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).

Impact of Chemotherapy-Induced Nausea on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2

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).

Impact of Chemotherapy-Induced Vomiting on Daily Life by the Functional Living Index-Emesis Questionnaire in Cycle 2

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)

Efficacy Phase (Second Cycle)

Scientific Director / Medical Lead / Project Manager

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).

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).

Efficacy Phase (Second Cycle):

Breast Cancer

Corporació Sanitaria Parc Taulí

Hospital Universitario Príncipe de Asturias

Hospital Universitario Fundación Alcorcón

Complejo Hospitalario Universitario A Coruña

Centro Oncológico de Galicia

Hospital del Mar

Hospital Clinic i Provincial

Complejo Hospitalario de Jaén

Hospital Universitario Arnau de Vilanova de Lleida

Complejo Hospitalario Xeral-Calde

Hospital Clínico Universitario San Carlos

Hospital Arnau de Vilanova de Valencia

Hospital Clínico Universitario Lozano Blesa

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

A Prospective, Open Label, Non-comparative Trial to Determine the Incidence of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated With the Docetaxel-Cyclophosphamide Regimen in Early Breast Cancer Patients

Spanish Breast Cancer Research Group

Merck Sharp & Dohme Corp.

Patients that experiment emesis within the first cycle in spite of the administration of antiemetics, may opt to participate in a subsequent efficacy phase

Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.

Dacarbazine

Gender

Region of Enrollment

Complete response (CR): disappearance of all target lesions, disappearance of all non-target lesions, normalization of tumor level marker
Partial response (PR): at least 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD, persistence of one or more non-target lesion and/or maintenance of tumor marker level above the upper limits of normal
Stable disease (SD): neither sufficient shrinkage in target lesions to qualify for PR nor sufficient increase to qualify for progressive disease taking as references the smallest sum LD since the treatment started, persistence of one or more non-target lesion and/or maintenance of tumor marker level above the normal limits of normal
Progressive disease (PD): at least 20% increase in the sum of the LD of target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

Best Anatomical Tumor Response

Grade 3 neutropenia = absolute neutrophil count of <1000 - 500/mm^3
Grade 4 neutropenia = absolute neutrophil count of <500/mm^3

Rate of Neutropenia (Grade 3/4)

Rate of Nausea/Emesis (Any Grade)

Comparison of the SUV at up to 3 Tumor Sites

Complete metabolic response (CMR)-complete resolution of all metabolically active target and non-target lesions, and no interval development of new lesions.
Partial metabolic response (PMR)
Target lesions: 20% or greater decrease in maximum SUV from baseline. No unequivocal metabolic progression of non-target disease, and no unequivocal new lesions.
Non-target lesions: decrease in total number of non-target lesions, without complete resolution of metabolically active disease, or unequivocal decrease in degree of FDG activity within >50% of the lesions. No unequivocal new lesions.
Stable metabolic disease (SMD): does not qualify for CMR, PMR, or PMD.
Progressive metabolic disease (PMD):
Unequivocal development of one more new metabolically active lesions
Target lesion: 20% or greater increase in maximum SUV from baseline.
Non-target lesions: unequivocal increase in FDG activity

Overall Tumor Metabolic Response

Partial Metabolic Response

Stable Metabolic Disease

Progressive Metabolic Disease

Total

Correlate the Tumor Metabolic Response Rate With the Tumor Anatomic Response Rate

Overall Disease Control Rate

-Progression - At least a 20% increase in the sum of the longest diameter (LD) of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.

Time to Progression (TTP)

Overall Survival

Correlate the Time to Progression With Best Anatomic Response

Correlate Time to Progression With Best Metabolic Response

Correlate Overall Survival With Best Anatomic Response

Correlate Overall Survival With Best Metabolic Response

Overall Study

Brian Van Tine, M.D., Ph.D.

Sarcoma

Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

5 hydroxytryptamine/cancer mamar

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

Dacarbazine for Metastatic Soft Tissue and Bone Sarcoma

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