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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Eisai Inc.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01328249
First received: March 22, 2011
Last updated: August 28, 2014
Last verified: August 2014
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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. ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Subjects will be followed for approximately 3 years after the last dose of the study treatment.


Estimated Enrollment: 80
Study Start Date: April 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: August 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Male and female subjects aged > 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 >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 >40 mL/min per the Cockcroft and Gault formula.
  • Adequate bone marrow function as evidenced by ANC >1.5 x 109/L, hemoglobin >10.0 g/dL, and platelet count >100 x 109/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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01328249

Contacts
Contact: Yvonne Noble (201) 746-2036 Yvonne_Noble@eisai.com

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Tiffany Traina    212-639-5209      
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: Jessicca Rege, PhD Eisai Inc.
  More Information

No publications provided

Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT01328249     History of Changes
Other Study ID Numbers: E7389-A001-210
Study First Received: March 22, 2011
Last Updated: August 28, 2014
Health Authority: United States: Food and Drug Administration

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
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014