Dose-Dense Epirubicin and Cyclophosphamide (EC) Followed by Paclitaxel in Breast Cancer: Feasibility

NCT00617370

Last updated date
Study Location
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer, Adenocarcinoma of the Breast
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 entry.

- 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 trial.

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Stage IV breast cancer


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


- 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
months.


- 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.

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Breast Cancer, Adenocarcinoma of the BreastDose-Dense Epirubicin and Cyclophosphamide (EC) Followed by Paclitaxel in Breast Cancer: Feasibility
NCT00617370
  1. New York, New York
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Dose-Dense Epirubicin and Cyclophosphamide (EC) Followed by Paclitaxel in Breast Cancer: Feasibility
Official Title  ICMJE Pilot Study of Dose-Dense Epirubicin and Cyclophosphamide (EC) Followed by Paclitaxel in High-Risk Breast Cancer: Feasibility
Brief Summary

The purpose of this study is to give a drug regimen that is hoped to be effective in preventing cancer from coming back. Since it is an aggressive breast cancer, there is a moderate to high chance that the cancer may come back. The standard treatment for this tumor type includes a chemotherapy regimen with drugs named epirubicin (E) and cyclophosphamide (C) in a vein every 2 weeks for 4 treatments, followed by a drug named paclitaxel, every 2 weeks in your vein for 4 treatments.

This study is an experimental study in which you will be given 6 cycles of EC followed by 6 cycles of paclitaxel. The purpose of getting 2 more cycles of EC and 2 more cycles of paclitaxel than what is normally given is to study a regimen that may be more effective than the current standard treatment in preventing the recurrence of this cancer. Specifically, in this study we are looking for side-effects and risks of these drugs as more cycles are given.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Adenocarcinoma of the Breast
Intervention  ICMJE Drug: epirubicin, cyclophosphamide, Paclitaxel,
EC (epirubicin 100 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 6 treatments with pegfilgrastim SQ day # 2 (6 mg). Paclitaxel (175 mg/m2) q 14 days x 6 treatments with pegfilgrastim SQ day # 2 (6 mg).
Study Arms  ICMJE Experimental: 1
The regimen consists of EC (epirubicin 100 mg/m2, cyclophosphamide 600 mg/m2) q 14 days x 6 with pegfilgrastim subcutaneously (SQ) on day # 2, followed by paclitaxel (175 mg/m2) q 14 days x 6 with pegfilgrastim SQ on day # 2.
Intervention: Drug: epirubicin, cyclophosphamide, Paclitaxel,
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2008)
38
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 entry.
  • 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 trial.
  • 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 cancer.
  • 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 months.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00617370
Other Study ID Numbers  ICMJE 04-065
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • Amgen
  • Pfizer
Investigators  ICMJE
Principal Investigator:Chau Dang, MDMemorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP