G-CSF in Preventing Neutropenia in Women Receiving Chemotherapy for Breast Cancer

Centre Francois Baclesse

Status and phase: Completed; Phase 2

Conditions: Chemotherapeutic Agent Toxicity; Breast Cancer; Neutropenia

Treatments: Biological: filgrastim

Study type: Interventional

Funder types: Other

Identifiers

NCT00771433

CDR0000599535

FRE-CFB-LENO-SEIN

FRE-CFB-CFB/2007-01

INCA-RECF0516

EUDRACT-2007-002753-23

CHUGAI-FRE-CFB-LENO-SEIN

Details and patient eligibility

About

RATIONALE: G-CSF may prevent or reduce febrile neutropenia in women receiving chemotherapy for breast cancer. It is not yet known which G-CSF regimen is more effective in preventing neutropenia.

PURPOSE: This phase II trial is studying how well G-CSF works in preventing neutropenia in women receiving chemotherapy for breast cancer.

Full description

OBJECTIVES:

Primary

• Evaluate the efficacy of filgrastim (G-CSF) in preventing hematological toxicity in women with breast cancer receiving neoadjuvant or adjuvant chemotherapy.

Secondary

• Compare actual vs theoretical dose intensity.

OUTLINE: This is a multicenter study. Patients are stratified according to age (< 65 years vs ≥ 65 years) and prior chemotherapy (adjuvant vs neoadjuvant). Patients are assigned to 1 of 2 groups.

• Group 1: Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 6-11 of each course of chemotherapy as primary prophylaxis. Chemotherapy courses repeat every three weeks for 3-6 courses.
• Group 2: Patients receive G-CSF SC once daily on days 6-11 of each course of chemotherapy as primary prophylaxis. Chemotherapy courses repeat every three weeks for 3-6 courses. Patients may also receive secondary prophylaxis with G-CSF if they experience an episode of neutropenia.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Diagnosis of breast cancer

• Receiving 1 of the following neoadjuvant or adjuvant chemotherapy regimens:

  • Six courses of epirubicin hydrochloride and docetaxel
  • Six courses of fluorouracil, epirubicin hydrochloride, and cyclophosphamide (FEC) 100 or 3 courses of FEC 100 and 3 courses of docetaxel 100

• Must have received at least 2 chemotherapy regimens prior to study therapy

• No malignant hematological disease

• Hormone receptor status not specified

PATIENT CHARACTERISTICS:

• Menopausal status not specified
• Not pregnant or nursing
• Fertile patients must use effective contraception
• No contraindications to standard neoadjuvant or adjuvant chemotherapy
• No known hypersensitivity to G-CSF or any of its components
• No patients deprived of liberty or under guardianship
• No psychological, familial, social, or geographical reasons preventing follow-up

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No concurrent participation in another experimental drug study

Trial design

120 participants in 2 patient groups

Group 1

Experimental group

Description:

Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 6-11 of each course of chemotherapy as primary prophylaxis. Chemotherapy courses repeat every three weeks for 3-6 courses.

Treatment:

Biological: filgrastim

Group 2

Experimental group

Description:

Patients receive G-CSF SC once daily on days 6-11 of each course of chemotherapy as primary prophylaxis. Chemotherapy courses repeat every three weeks for 3-6 courses. Patients may also receive secondary prophylaxis with G-CSF if they experience an episode of neutropenia.

Treatment:

Biological: filgrastim