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Pilot Study of Dose-Dense Epirubicin and Cyclophosphamide (EC) Followed by Paclitaxel in High-Risk Breast Cancer: Feasibility

18 Years
Not Enrolling
Breast Cancer, Adenocarcinoma of the Breast

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Trial Information

Pilot Study of Dose-Dense Epirubicin and Cyclophosphamide (EC) Followed by Paclitaxel in High-Risk Breast Cancer: Feasibility

Inclusion Criteria:

- Patients must have histologically confirmed adenocarcinoma of the breast confirmed at
MSKCC or MSKCC satellites. Patients with breast cancer, regardless of tumor size or
nodal status, are eligible for the study. Pathology will be assessed in the standard
fashion (ie: HER-2/neu, estrogen receptor, and progesterone receptor status). Results
of HER-2/neu, estrogen receptor, and progesterone receptor are not required for study

- Patients must be ≥18 years of age.

- Patients must have an ECOG PS of 0 or 1.

- If patients are offered chemotherapy postoperatively, then they must be within 84
days from the final surgical procedure required to treat the primary tumor(s). If
patients are offered chemotherapy preoperatively, then they can receive treatment at
anytime per MD's discretion. Patients may have bilateral synchronous breast tumors.

- Patients may have received hormonal therapy for the purpose of chemoprevention but
must be willing to discontinue prior to enrollment and while participating in this

- If patients have peripheral neuropathy, it must be < than or equal grade 1.

- 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.

- Absolute neutrophil count (ANC) ≥1000/µL and platelet count ≥100,000/µL.

- Total Bilirubin must be within normal limits. Transaminases (SGOT and/or SGPT) may be
up 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.

- Negative HCG pregnancy test for premenopausal women of reproductive capacity and for
women less than 12 months after the menopause.

- LVEF (by multi-gated radionuclide angiography or MUGA scan or by echocardiography)at
or above institutional lower limit of normal

- Patients must give written, informed consent indicating their understanding of and
willingness to participate in the study.

Exclusion Criteria:

- Stage IV breast cancer

- Chemotherapy, radiation therapy, immunotherapy, or biotherapy for current breast

- Pregnant or lactating patients.

- Patients with a concurrently active second malignancy, other than adequately treated
nonmelanoma 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 known allergy/hypersensitivity to doxorubicin, cyclophosphamide,
paclitaxel (or other drugs formulated in Cremophor EL) or E. coli-derived proteins.

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the feasibility and safety of this dose-dense regimen.

Outcome Time Frame:

conclusion of the study

Safety Issue:


Principal Investigator

Chau Dang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

November 2004

Completion Date:

June 2008

Related Keywords:

  • Breast Cancer
  • Adenocarcinoma of the Breast
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Breast Neoplasms



Memorial Sloan Kettering Cancer CenterNew York, New York  10021