Trial Outcomes & Findings for Cyclophosphamide and Paclitaxel With or Without Trastuzumab in Stage I-II Breast Cancer Who Have Undergone Surgery (NCT NCT01106898)
NCT ID: NCT01106898
Last Updated: 2023-09-28
Results Overview
Recurrence-free survival curves will be plotted for subjects treated with stage I and II disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
112 participants
Primary outcome timeframe
Time from the start of treatment to recurrence, second malignancy, or death as a first event, assessed up to 3 years
Results posted on
2023-09-28
Participant Flow
Of the 112 subjects consented for this study, 3 were ineligible, 9 withdrew before study treatment starting. Only 100 subjects treated were available for analysis.
Participant milestones
| Measure |
Treatment (Chemotherapy With or Without Maintenance Therapy)
SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.
cyclophosphamide, paclitaxel, trastuzumab: Given IV
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|---|---|
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Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
94
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Treatment (Chemotherapy With or Without Maintenance Therapy)
SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.
cyclophosphamide, paclitaxel, trastuzumab: Given IV
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|---|---|
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Overall Study
Adverse Event
|
6
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Baseline Characteristics
Cyclophosphamide and Paclitaxel With or Without Trastuzumab in Stage I-II Breast Cancer Who Have Undergone Surgery
Baseline characteristics by cohort
| Measure |
Treatment (Chemotherapy With or Without Maintenance Therapy)
n=112 Participants
SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.
cyclophosphamide, paclitaxel, trastuzumab: Given IV
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|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
112 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
107 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black, not of hispanic origin
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
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1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
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112 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time from the start of treatment to recurrence, second malignancy, or death as a first event, assessed up to 3 yearsRecurrence-free survival curves will be plotted for subjects treated with stage I and II disease.
Outcome measures
| Measure |
Treatment (Chemotherapy With or Without Maintenance Therapy)
n=100 Participants
SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.
cyclophosphamide, paclitaxel, trastuzumab: Given IV
|
|---|---|
|
Recurrence-free Survival
|
98 percentage of subjects
Interval 92.2 to 99.5
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Adverse Events
Treatment (Chemotherapy With or Without Maintenance Therapy)
Serious events: 16 serious events
Other events: 57 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Treatment (Chemotherapy With or Without Maintenance Therapy)
n=102 participants at risk
SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.
cyclophosphamide, paclitaxel, trastuzumab: Given IV
|
|---|---|
|
Immune system disorders
Anaphylaxis
|
0.98%
1/102 • Number of events 1 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
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General disorders
Fever
|
0.98%
1/102 • Number of events 1 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.98%
1/102 • Number of events 1 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
|
Vascular disorders
thromboembolic event
|
2.0%
2/102 • Number of events 2 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
2.9%
3/102 • Number of events 3 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
|
Infections and infestations
Skin Infection
|
0.98%
1/102 • Number of events 1 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.98%
1/102 • Number of events 1 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
2/102 • Number of events 2 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
|
Gastrointestinal disorders
Duodenal perforation
|
0.98%
1/102 • Number of events 1 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
|
Investigations
Ejection fraction decreased
|
0.98%
1/102 • Number of events 1 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.98%
1/102 • Number of events 1 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
|
Gastrointestinal disorders
Constipation
|
0.98%
1/102 • Number of events 1 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
|
Gastrointestinal disorders
Diarrhea
|
0.98%
1/102 • Number of events 1 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
|
Infections and infestations
Urinary Tract Infection
|
0.98%
1/102 • Number of events 1 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
|
Infections and infestations
Sepsis
|
0.98%
1/102 • Number of events 1 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
|
Infections and infestations
Infections and Infestations - Other
|
0.98%
1/102 • Number of events 1 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
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Investigations
Neutrophil count decreased
|
2.0%
2/102 • Number of events 2 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
|
Infections and infestations
Lung infection
|
0.98%
1/102 • Number of events 1 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
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Cardiac disorders
SinusTachycardia
|
0.98%
1/102 • Number of events 1 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
Other adverse events
| Measure |
Treatment (Chemotherapy With or Without Maintenance Therapy)
n=102 participants at risk
SYSTEMIC CHEMOTHERAPY: Patients receive cyclophosphamide IV over 1 hour and paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE THERAPY (Her-2 neu positive patients): Patients receive trastuzumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 5 courses and then every 21 days for 14 courses in the absence of disease progression or unacceptable toxicity.
cyclophosphamide, paclitaxel, trastuzumab: Given IV
|
|---|---|
|
Investigations
Lymphocyte count decreased
|
7.8%
8/102 • Number of events 12 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
22.5%
23/102 • Number of events 31 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
|
Investigations
Neutrophil count decreased
|
13.7%
14/102 • Number of events 29 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.9%
7/102 • Number of events 7 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
|
Nervous system disorders
Nervous system disorders - Other
|
6.9%
7/102 • Number of events 7 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
|
|
Investigations
White blood cells decreased
|
8.8%
9/102 • Number of events 13 • Adverse events are collected from time the subject signs consent and ending 4 weeks following final chemotherapy (16 weeks for those not taking trastuzumab, Her-2 neu positive (add trastuzumab) patients this is 56 weeks). All subjects were also followed for only neuro and cardio toxicities for up to 3 months after final chemotherapy.
Grade 3 and higher are reported per the CTC version 3.0 Number of participants for adverse event reporting is out of 102 patients because per the protocol every patient who fulfills all aspects of patient eligibility who receives a partial or complete course of chemotherapy will be evaluable for toxicity. There were 2 patients who started treatment and were removed from the study after 1 cycle due to adverse events.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place