Clinical trial NCT00771433: G-CSF in Preventing Neutropenia in Women Receiving Chemotherapy for Breast Cancer
Official title: Evaluation of the Efficacy of Adding Daily G-CSF (Granulocyte Colony Stimulating Factor) for Prevention of Hematologic Toxicity Due to Neoadjuvant or Adjvuant Chemotherapy in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Chemotherapeutic Agent Toxicity
Neutropenia
Keywords: neutropenia
chemotherapeutic agent toxicity
recurrent breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2008-10-13
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed 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.

Eligibility 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

Primary outcomes:
measure: Occurrence of febrile neutropenia
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre Regional Francois Baclesse
Study officials:
affiliation: Centre Francois Baclesse
name: Corinne Delcambre
role: STUDY_CHAIR
References: