Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
XM22-03
Study information
Scientific title
Efficacy and safety of XM22 compared to pegfilgrastim in patients with breast cancer receiving chemotherapy. A multinational, multicentre, randomised, double-blind controlled study
Acronym
Study hypothesis
Demonstration of non-inferiority of XM22 versus pegfilgrastim in patients with breast cancer during the first cycle of chemotherapy with respect to the duration of severe neutropenia (DSN)
Ethics approval
At each study centre, the protocol (dated 29 September 2009) and informed consent form for this study were reviewed and approved by Independent Ethic Committees before inclusion of patients. Amendments to the protocol will be reviewed and approved in the same manner before being implemented.
Study design
Multinational multicentre randomised double blind active controlled phase III study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Breast cancer patients with chemotherapy induced neutropenia
Intervention
XM22: 1 syringe 6 mg per cycle (cycles 1-4)
Pegfilgrastim: 1 syringe 6 mg per cycle (cycles 1-4)
The duration of the study will be 12 weeks. The duration of follow up will be 360 days.
Intervention type
Drug
Phase
Phase III
Drug names
XM22, pegfilgrastim
Primary outcome measure
Duration of severe neutropenia in cycle 1, defined as grade 4 neutropenia with an ANC <0.5 x 10*9/L
Secondary outcome measures
1. Incidence of febrile neutropenia (FN) by cycle and across all cycles (FN defined as body temperature of >38.5°C for at least one hour, measured orally with a certified standard device, and ANC <0.5 x 10*9/L, including cases of neutropenic sepsis or neutropenic serious or life-threatening infection)
2. Time in hospital and time in intensive care unit due to FN or connected infections
3. Incidence of treatment with i.v. antibiotics due to FN or connected infections
4. DSN in cycles 2, 3, and 4
5. Incidence of severe neutropenia, defined as grade 4 neutropenia with an ANC <0.5 x 10*9/L in cycles 1, 2, 3 and 4
6. Duration and incidence of very severe neutropenia, defined as ANC <0.1 x 10*9/L in cycles 1, 2, 3 and 4
7. Depth of ANC nadir in cycles 1, 2, 3, and 4
8. Time to ANC nadir in cycles 1, 2, 3, and 4
9. Time to ANC recovery in cycles 1, 2, 3, and 4
10. Percentage of actually delivered vs. scheduled cumulative chemotherapy dose
11. Proportion of patients with chemotherapy doses reduced, omitted, or delayed
12. Number of days of delay of chemotherapy
13. Overall quality of life as measured by the EORTC QLQ-C30 (version 3) and the EORTC QLQ-BR23
Overall trial start date
01/05/2010
Overall trial end date
01/03/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Provide signed and dated written informed consent
2. Men and women aged ≥18 years
3. The patient must be able to understand and follow instructions and must be able to participate in the study for the entire period
4. Breast cancer high risk stage II, III or IV according to American Joint Committee on Cancer (AJCC) classification
5. Patients planned and eligible to receive 4 cycles of treatment with docetaxel/doxorubicin as routine chemotherapy for their breast cancer disease
6. Chemotherapy naïve
7. Eastern Cooperative Oncology Group (ECOG) performance status ≤2
8. Absolute Neutrophil Count (ANC) ≥1.5 x 10*9/L
9. Platelet count ≥100 x 10*9/L
10. Adequate cardiac function (including left ventricular ejection fraction ≥50% as assessed by echocardiography or equivalent method within 4 weeks prior to randomisation)
11. Adequate hepatic function, i.e. ALT and AST <2.5 x ULN, alkaline phosphatase <5 x ULN, bilirubin <ULN
12. Adequate renal function, i.e. creatinine <1.5 x ULN
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200 (100 per treatment group)
Participant exclusion criteria
1. Participation in a clinical trial within 30 days before randomisation.
2. Previous exposure to filgrastim, pegfilgrastim or lenograstim or other G-CSFs in clinical development less than 6 months before randomisation.
3. Known hypersensitivity to docetaxel or doxorubicin, filgrastim, pegfilgrastim or lenograstim.
4. Underlying neuropathy of grade 2 or higher.
5. Treatment with systemically active antibiotics within 72 hours before chemotherapy.
6. Treatment with lithium at inclusion or planned during the entire study.
7. Chronic use of oral corticosteroids.
8. Prior radiation therapy or tumour surgery within 4 weeks before randomisation.
9. Prior bone marrow or stem cell transplantation.
10. Prior malignancy within the previous 5 years other than basal cell or squamous cell carcinomas or in situ carcinoma of the cervix.
11. Any illness or condition that in the opinion of the investigator may affect the safety of the patient or the evaluation of any study endpoint.
12. Pregnant or nursing women. Women of child-bearing potential who do not agree to use a highly effective method of birth control during the entire duration of the study. Highly effective methods of birth control are defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, hormonal IUDs, sexual abstinence or vasectomised partner. Female patients will be considered to be of child-bearing potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years (Postmenopausal is defined as the time after which a woman has experienced twelve consecutive months of amenorrhea without a period).
Recruitment start date
01/05/2010
Recruitment end date
01/03/2012
Locations
Countries of recruitment
Bulgaria, Russian Federation, Ukraine
Trial participating centre
Merckle GmbH
Ulm
89075
Germany
Sponsor information
Organisation
BioGeneriX AG (Germany)
Sponsor details
High-Tech-Park Neckarau
Janderstraße 3
Mannheim
68199
Germany
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
BioGeneriX AG (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list