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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00771433

Enrollment

120

Registered

2008-10-13

Start date

2007-10-31

Completion date

Unknown

Last updated

2011-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

BIOLOGICALfilgrastim

Given subcutaneously

Study design

Allocation

NON_RANDOMIZED

Primary purpose

SUPPORTIVE_CARE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Occurrence of febrile neutropenia	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026