Trial Outcomes & Findings for Application Of Epirubicin Within A Neo-/Adjuvant Chemotherapy In Patients With Primary Breast Cancer (NCT NCT01061359)

NCT ID: NCT01061359

Last Updated: 2010-12-29

Results Overview

Percentage of participants with DFS who completed 5 year follow-up visit.

• Recruitment status: COMPLETED
• Target enrollment: 1981 participants
• Primary outcome timeframe: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y
• Results posted on: 2010-12-29

Participant Flow

A total of 1982 participants were enrolled, however, during database lock, 10 participants were identified as duplicates. Therefore, a total of 1972 unique participants were identified for the study.

Participant milestones

Measure	Entire Study Population Includes all groups enrolled in the study
Overall Study STARTED	1972
Overall Study COMPLETED	670
Overall Study NOT COMPLETED	1302

Reasons for withdrawal

Measure	Entire Study Population Includes all groups enrolled in the study
Overall Study Death	32
Overall Study Lost to Follow-up	1072
Overall Study Relapse	187
Overall Study Secondary neoplasm	11

Baseline Characteristics

Application Of Epirubicin Within A Neo-/Adjuvant Chemotherapy In Patients With Primary Breast Cancer

Baseline characteristics by cohort

Measure	Entire Study Population n=1972 Participants Includes all groups enrolled in the study
Age Continuous	54.73 years n=5 Participants
Age, Customized >=20 and <30 years	12 participants n=5 Participants
Age, Customized >=30 and <40 years	167 participants n=5 Participants
Age, Customized >=40 and <50 years	512 participants n=5 Participants
Age, Customized >=50 and <60 years	568 participants n=5 Participants
Age, Customized >=60 and <70 years	557 participants n=5 Participants
Age, Customized >=70 and <80 years	101 participants n=5 Participants
Age, Customized >=80 and <90 years	1 participants n=5 Participants
Age, Customized Unknown	54 participants n=5 Participants
Sex: Female, Male Female	1972 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y

Population: Intent to treat (ITT)

Percentage of participants with DFS who completed 5 year follow-up visit.

Outcome measures

Measure	Epirubicin n=1972 Participants Includes groups enrolled to receive all treatments of epirubicin
Percentage of Participants With Disease Free Survival (DFS)	83.7 Percentage of participants

SECONDARY outcome

Timeframe: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y

Population: 16.3% of patients had experienced disease progression by the end of the study. As this is less than 50% the median time to progression is not defined.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3m, 6m, 9m, 1y, 1.5y, 2y, 2.5y, 3y, 3.5y, 4y, 4.5y, 5y

Population: Median time to recurrence was not reached.

Outcome measures

Outcome data not reported

Adverse Events

Epirubicin

Serious events: 16 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Epirubicin n=1972 participants at risk Includes groups enrolled to receive all treatments of epirubicin
Blood and lymphatic system disorders Aneaemia	0.15% 3/1972 • Number of events 3 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Blood and lymphatic system disorders Leukopenia	0.30% 6/1972 • Number of events 6 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Blood and lymphatic system disorders Neutropenia	0.15% 3/1972 • Number of events 3 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Blood and lymphatic system disorders Pancytopenia	0.20% 4/1972 • Number of events 4 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Blood and lymphatic system disorders Thrombocytopenia	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Cardiac disorders Cardiac failure acute	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Gastrointestinal disorders Diarrhoea	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Gastrointestinal disorders Intestinal infarction	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Gastrointestinal disorders Nausea	0.10% 2/1972 • Number of events 2 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Gastrointestinal disorders Stomatitis	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Gastrointestinal disorders Vomiting	0.10% 2/1972 • Number of events 2 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
General disorders Death	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
General disorders Disease progression	0.10% 2/1972 • Number of events 3 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
General disorders General physical health deterioration	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
General disorders Mucosal inflammation	0.15% 3/1972 • Number of events 3 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
General disorders Pyrexia	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Infections and infestations Candidiasis	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Infections and infestations Cellulitis	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Infections and infestations Mastitis	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Infections and infestations Pneumonia	0.05% 1/1972 • Number of events 2 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Infections and infestations Sepsis	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.15% 3/1972 • Number of events 4 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bronchial carcinoma	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to nervous system	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.10% 2/1972 • Number of events 2 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian cancer	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Nervous system disorders Cerebral haemorrhage	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Nervous system disorders Nervous system disorder	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Nervous system disorders Transient ischaemic attack	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Psychiatric disorders Confusional state	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Skin and subcutaneous tissue disorders Blister	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.
Vascular disorders Thrombosis	0.05% 1/1972 • Number of events 1 Only spontaneous adverse events were collected as reported by health care professionals. All events are reported under serious adverse events.

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

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Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER