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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


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Chemotherapeutic Agent Toxicity, Neutropenia

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Supportive Care

Outcome Measure:

Occurrence of febrile neutropenia

Safety Issue:

No

Principal Investigator

Corinne Delcambre

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Francois Baclesse

Authority:

United States: Federal Government

Study ID:

CDR0000599535

NCT ID:

NCT00771433

Start Date:

October 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • Chemotherapeutic Agent Toxicity
  • Neutropenia
  • 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
  • Breast Neoplasms
  • Neutropenia

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