Pilot Study of Dose Dense Adjuvant CMF (Cyclophosphamide, Methotrexate, Fluorouracil) at 14 and 10-11 Day Intervals for Women With Early Stage Breast Cancer
- Patients must have histologically confirmed adenocarcinoma of the breast confirmed at
MSKCC within 3 months of enrollment. Patients with inflammatory breast cancer are not
eligible for the study. Pathology will be assessed in the standard fashion. Results
of HER-2/neu, estrogen receptor, and progesterone receptor are required for study
- The patient cannot be Her-2/neu over-expressing either by immunohistochemistry or
FISH as per hospital laboratory standard whether institutional or outside laboratory.
- Patients must be > than or equal to 18 years of age
- Patients must have a Karnofsky score of > than or equal to 80
- Patients may have received hormonal therapy for the purpose of chemoprevention but
must be willing to discontinue at least 24 hours prior to enrollment and while
participating in this trial.
- Patients will have completed their definitive breast surgery (mastectomy or breast
- Patients must be ready to begin therapy within 84 days from the final surgical
procedure required to treat their primary tumor
- Patients must be stage I-II
- Absolute neutrophil count (ANC) > than or equal to 1500/µL and platelet count > than
or equal to 100,000/µL
- Total bilirubin must be < than or equal to 1.1 mg/dL or within normal institutional
limits if outside MSKCC. Transaminases (SGOT/AST and/or SGPT/ALT) may be up to < than
or equal to 92.5 U/L or < than or equal to 2.5 x institutional upper limit of normal
(ULN) if alkaline phosphatase is < than or equal to ULN, or alkaline phosphatase may
be up to 4 x ULN if transaminases are < than or equal to ULN.
- Serum creatinine must be within 0.6-1.3 mg/dL or within normal institutional limits
if outside MSKCC.
- Patients must be willing to discontinue sex hormonal therapy e.g., birth control
pills, ovarian hormonal replacement therapy, etc., prior to enrollment. Women of
childbearing potential must be willing to consent to using effective contraception
while on treatment and for a reasonable period thereafter.
- Patients must give written, informed consent indicating their understanding and
willingness to participate in the study.
- Brachytherapy after lumpectomy is permitted.
- Stage III-IV breast cancer
- Prior chemotherapy or radiation therapy is excluded except for
brachytherapy.Radiation for patients on this protocol will be given, if indicated,
after the completion of chemotherapy.
- Pregnant or lactating patients
- Patients with a concurrently active second malignancy, other than adequately treated
non-melanoma skin cancers or in situ cervical cancer. Patients with other non-mammary
malignancies must have been disease-free for at least five years.
- Patients with unstable angina, congestive heart failure, current use of digitalis,
betablockers, or calcium blockers for therapy of congestive heart failure, arrhythmia
requiring medical therapy, or with a history of a myocardial infarction within 12
- Patients with a psychiatric illness that would prevent them from understanding the
nature of the investigational therapy and complying with protocol requirements.
- Patients with concurrent medical conditions, which, in the judgment of the
investigator, would make them inappropriate candidates for study enrollment
- Patients with active, unresolved infections
- Patients that have known sensitivity to E. coli derived proteins, PEG-filgrastim,
filgrastim, or any component products.
- Patients must be Her 2/neu non-over-expressing.