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Dose Dense Doxorubucin and Cyclophosphamide Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01328249
First Posted: April 4, 2011
Last Update Posted: March 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eisai Inc.
  Purpose
The purpose of this study is to assess the feasibility of dose-dense doxorubicin and cyclophosphamide followed by eribulin mesylate for adjuvant treatment of early stage breast cancer.

Condition Intervention Phase
Her2normal Drug: eribulin mesylate Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Single-Arm, Feasibility Study of Dose Dense Doxorubicin and Cyclophosphamide (AC) Followed by Eribulin Mesylate for the Adjuvant Treatment of Early Stage Breast Cancer

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • To measure the feasibility of the regimen for each individual subject. The regimen is considered feasible if the subject is able to complete the eribulin portion of the regimen without dose delay or reduction [ Time Frame: Treatment will be administered over approximately 20 weeks, i.e., dose-dense AC for 4 cycles during the first 8 weeks and eribulin mesylate for 4 cycles during the next 12 weeks. ]
    Subjects will be followed for approximately 3 years after the last dose of the study treatment.Feasibility rates will be calculated with or without growth factor support.


Secondary Outcome Measures:
  • To evaluate the toxicities of 4 cycles of AC followed by 4 cycles of eribulin mesylate as measured by the monitoring and recording of all adverse events, clinical laboratory results, vital signs, physical examinations, ECGs, and LVEF. [ Time Frame: Treatment will be administered over approximately 20 weeks, i.e., dose-dense AC for 4 cycles during the first 8 weeks and eribulin mesylate for 4 cycles during the next 12 weeks. ]
    Subjects will be followed for approximately 3 years after the last dose of the study treatment.


Enrollment: 81
Actual Study Start Date: March 2, 2011
Estimated Study Completion Date: November 2017
Primary Completion Date: October 27, 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Doxorubicin and cyclophosphamide followed by eribulin mesylate Drug: eribulin mesylate
Dose dense doxorubicin and cyclophosphamide for 4 cycles during the first 8 weeks followed by eribulin mesylate 1.4mg/m2 for 4 cycles during the next 12 weeks

Detailed Description:
This is a single-center, single-arm Phase II trial to assess the feasibility of dose-dense adjuvant chemotherapy in subjects with early stage (I-III), HER-2 normal breast cancer. A total of 80 adult subjects will be enrolled in order to have 73 subjects who start the eribulin portion of the adjuvant study regimen. After completion of 4 cycles of AC, each subject will begin 4 cycles of eribulin mesylate 1.4 mg/m2 intravenously over 2 to 5 minutes on Days 1 and 8 of every 21 day cycle.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Male and female subjects aged greater than 18 years
  • Histologically confirmed Stage I to III invasive breast cancer. Subjects may have more than one synchronous primary breast tumor.
  • Her-2 normal as determined by fluorescence in situ hybridization (FISH) or 0 or 1+ by immunohistochemistry (IHC) staining.
  • Subject is a candidate for chemotherapy in the adjuvant setting. Adjuvant therapy must begin within 84 days of the final surgical procedure for breast cancer.
  • Adequate cardiac function, defined by baseline LVEF greater than 50% by Multiple Gated Acquisition (MUGA) scan or echocardiogram.
  • ECOG performance status of 0 or 1.
  • Adequate renal function as evidenced by serum creatinine less than 1.5 mg/dL or calculated creatinine clearance greater than 40 mL/min per the Cockcroft and Gault formula.
  • Adequate bone marrow function as evidenced by ANC greater than 1.5 x 10^9/L, hemoglobin greater than 10.0 g/dL, and platelet count greater than 100 x 10^9/L.
  • Adequate liver function as evidenced by bilirubin less than 1.5 times the upper limits of normal (ULN) and alkaline phosphatase (AP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) less than 3 x ULN.
  • Females of childbearing potential must have a negative urine or beta-human chorionic gonadotropin serum pregnancy test within 2 weeks prior to Cycle 1, Day 1. A urine pregnancy test should be repeated prior to chemotherapy if not conducted within 72 hours of start of treatment. Female subjects of childbearing potential must agree to be abstinent or to use a highly effective method of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, intrauterine device (IUD), or have a vasectomized partner) having started for at least one menstrual cycle prior to starting study drug and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Perimenopausal women must be amenorrheic for at least 12 months to be considered of nonchildbearing potential. Male subjects who are not abstinent or who have undergone a successful vasectomy, who are partners of women of childbearing potential must use, or their partners must use, a highly effective method of contraception (e.g., condom + spermicide, condom + diaphragm with spermicide, IUD) starting for at least one menstrual cycle prior to starting study drug and throughout the entire study period and for 30 days (longer if appropriate) after the last dose of study drug. Subjects with partners using hormonal contraceptives must also be using an additional approved method of contraception (as described previously).
  • Subjects willing and able to comply with the study protocol for the duration of the study and provide written informed consent prior to any study-specific screening procedures with the understanding that the subject may withdraw consent at any time without prejudice.

Exclusion Criteria

  • Stage IV breast cancer.
  • Prior chemotherapy, radiation therapy, immunotherapy, or biotherapy for current breast cancer.
  • Nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude any of the study therapy drugs.
  • Subjects with a concurrently active second malignancy other than adequately treated nonmelanoma skin cancers or in situ cervical cancer.
  • Subjects with known positive human immunodeficiency virus (HIV) status.
  • Pregnancy or breast feeding at the time of study enrollment. Eligible subjects of reproductive potential (both sexes) must agree to use adequate contraceptive methods during study therapy.
  • Subjects with known allergy or hypersensitivity to doxorubicin, cyclophosphamide, or eribulin mesylate.
  • Inability to comply with the study and/or follow-up procedures.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01328249


Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Sam Misir Eisai Inc.
  More Information

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01328249     History of Changes
Other Study ID Numbers: E7389-A001-210
First Submitted: March 22, 2011
First Posted: April 4, 2011
Last Update Posted: March 13, 2017
Last Verified: March 2017

Keywords provided by Eisai Inc.:
Breast Cancer
HER2-normal Stage I to III invasive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Liposomal doxorubicin
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors