Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Auro del Giglio


Contact details

Faculdade de Medicina do ABC
Av. Principe de Gales
821 - anexo 3
Departamento de Oncologia
Santo André

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


Study hypothesis

XM02 is superior to placebo and equivalent to filgrastim on the duration of severe neutropenia in cycle 1.

Ethics approval

Romania: National Ethics Committee of Medicamentului Student Clinic (Comisia Nationala de Etica pentru Studiul Clinic al Medicamentului), Av. Sanatescu Str. No 48, Sect. 1, Bucharest, Date of approval: 19/05/2004 (No 1165)
Hungary: Ethics Committee for Clinical Pharmacology, Medical Research Council, Arany J.u. 6-8, H-1051 Budapest. Date of approval: 16/06/2004 (ref: 22972-1/2004-1017EKL)
Lithuania: Lietuvos Bioethics Committee (Lietuvos Bioetikos Komitetas), Kodas 8871059, Vilniaus g. 33-230, LT-2001. Date of approval: 01/06/2004 (ref: 2004-06-02 Nr. 19/3)
Russia: Ethics Committee at the Federal Body of Quality, Efficacy and Safety Control of Medicinal Remedies, 8, Petrovsky Bulvar, Building 1, 103051 Moscow. Date of approval: 16/06/2004 (ref: 2573)
Slovenia: Committee of the Republic of Slovenia for Medical Ethics. Date of approval: 22/06/2004 (ref: 55/06/04)
South Africa: Ethics Committee of the University of the Free State, Kellner Street, Bloemfontein 9301. Date of approval: 16/02/2005 (ref: No ETOVS Nr. 71/04)

Belarus, Chile, Poland: Centres received ethics approval before recruiting participants.

Study design

Multinational, multicentre, randomised, controlled study with parallel groups.

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Breast cancer treated by myelotoxic chemotherapy


Arm 1: XM02, 5 µg/kg body weight/day subcutaneously (s.c.)
Arm 2: Filgrastim, 5 µg/kg body weight/day s.c.
Arm 3: Placebo, 5 µg/kg body weight/day s.c.

The study drug/placebo was administered in each cycle of chemotherapy daily from day 2 (24 hours after chemotherapy) to maximum day 15, minimum 5 days. Study drug was stopped as soon as ANC >10 x 10^9/L was reached.

Intervention type



Not Specified

Drug names


Primary outcome measure

Duration of severe neutropenia in cycle 1

Secondary outcome measures

1. Secondary efficacy endpoints:
1.1. Incidence of observed febrile neutropenia (FN) (observed FN defined as body temperature of >38.5°C for more than 1 hour, measured axillary with a calibrated standard device, and ANC <0.5 x 10^9/L, both measured on the same day) and of protocol defined FN (intake of systemic antibiotics) by cycle and across all cycles
1.2. Duration of severe neutropenia in cycles 2 to 4
1.3. Depth of ANC nadir in cycles 1 to 4
1.4. Times to ANC recovery in cycles 1 to 4
1.5. Mortality

2. Safety endpoints, determined at the beginning and at the end of each chemotherapy cycle until day 85, antibody determination until day 180:
2.1. Adverse events (AEs)
2.3. Safety laboratory assessment
2.4. Physical examination
2.5. Injection site reactions
2.6. Vital signs
2.7. Eastern Cooperative Oncology Group (ECOG) performance
2.8. Immunogenicity (development of antibodies against study drug)

3. Pharmacokinetics in a subset of patients

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Signed and dated written informed consent
2. Age above or equal 18 years, both males and females
3. Breast cancer high risk stage II, or stage III or IV (classification according to American Joint Committee on Cancer [AJCC])
4. Patients planned/eligible to receive treatment with docetaxel/doxorubicin as routine chemotherapy (CTX) for their breast cancer disease
5. CTX naïve
6. Eastern Cooperative Oncology Group (ECOG) performance status below or equal 2
7. Absolute neutrophil count (ANC) above or equal 1.5 x 10^9/L
8. Platelet count above or equal 100 x 10^9/L
9. Adequate cardiac function (including left ventricular ejection fraction above or equal 50% as assessed by echocardiography within 4 weeks prior to randomisation)
10. Adequate hepatic function i.e., alanine and aspartate aminotransferases (ALT/AST) <2.5 x upper limit of normal (ULN), alkaline phosphatase (AP) <5 x ULN, bilirubin <ULN
11. Adequate renal function, i.e., creatinine <1.5 x ULN

Participant type


Age group




Target number of participants


Participant exclusion criteria

1. Participation in a clinical trial within 30 days before randomisation
2. Previous exposure to filgrastim, pegfilgrastim or lenograstim
3. Known hypersensitivity to docetaxel
4. Underlying neuropathy of grade 2 or higher
5. Treatment with systemically active antibiotics within 72 hours before CTX
6. Treatment with lithium
7. Chronic use of oral corticosteroids
8. Prior radiation therapy 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 could affect the safety of the patient or the evaluation of any study endpoint
12. Pregnant or nursing women were excluded. Women of child-bearing potential had to agree to use a chemical or barrier contraceptive during the treatment period.

Recruitment start date


Recruitment end date



Countries of recruitment

Belarus, Brazil, Chile, Hungary, Lithuania, Poland, Romania, Russian Federation, Slovenia, South Africa

Trial participating centre

Faculdade de Medicina do ABC
Santo André

Sponsor information


BioGeneriX AG (Germany)

Sponsor details

Janderstrasse 3
+49 621 875 5610

Sponsor type




Funder type


Funder name

BioGeneriX AG (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Publication citations

Additional files

Editorial Notes