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Completed

NCT Number: NCT00270894

Neoadjuvant Chemotherapy + Herceptin in HER2 Positive Stage II-III Breast Cancer Patients

The purpose of this study is to evaluate the effectiveness and tolerability of the combination of the following medications given every two weeks in HER2 positive breast cancer patients:

* trastuzumab (Herceptin) * epirubicin (Ellence) * cyclophosphamide (Cytoxan) * docetaxel (Taxotere)

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Key information

Conditions

Breast Neoplasm Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Advanced Medical Specialties, Miami, Florida, United States

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About this study

This is an investigator-initiated, Phase II, non-randomized, single-arm, prospective treatment study. The study will consist of neoadjuvant treatment period (weeks 1 to 20), surgical evaluation period (weeks 20 to 24), and a post-surgical/follow-up period (approximately 3 years). Subjects will be treated on an outpatient basis.

Neoadjuvant therapy will consist of epirubicin + cyclophosphamide given every 2 weeks for four cycles followed by a three week break. Subjects will then receive docetaxel every two weeks for four cycles + trastuzumab (one loading dose) then maintenance dose every 2 weeks for 4 treatments.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Non-pregnant females =/> 18 years of age
  • Non-inflammatory breast cancer stage IIA - IIIC or high risk node negative
  • Core biopsy of breast demonstrating invasive cancer and documented ER/PgR receptor status
  • Normal cardiac function and adequate hematologic function
  • Human epidermal growth factor receptor 2 protein (HER2) positive
  • No evidence of metastatic disease
  • ECOG Performance Status 0 - 1
  • Women of childbearing potential must agree to using effective contraception while on treatment and for at least 3 months post-treatment

Exclusion criteria

  • Treated with other investigational drugs within 30 days
  • Uncontrolled intercurrent disease or active infection
  • Known sensitivity to e. coli-derived proteins or polysorbate 80
  • Psychiatric illness or social situation that would limit study compliance
  • Pre-existing peripheral neuropathy > Grade 1
  • Cancer within 5 years of screening with the exception of surgically cured nonmelanomatous skin cancer; in-situ carcinoma of the cervix; or in-situ carcinoma of the breast
  • Bilateral synchronous breast cancer
  • Inflammatory breast cancer
  • Women who are pregnant or breast feeding

Treatment and study plan

Epirubicin

Drug

epirubicin (100 mg/m^2) every 2 weeks for 4 cycles

Other names: Ellence®

Cyclophosphamide

Drug

cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles

Other names: Cytoxan

docetaxel

Drug

docetaxel (75 mg/m^2) every 2 weeks for 4 cycles

Other names: Taxotere®

Trastuzumab

Drug

trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments

Other names: Herceptin®

Primary outcomes

  1. Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule

    Time frame: From the start of treatment through the neoadjuvant treatment period (approximately 20 weeks)

    Feasibility will be determined by evaluating the percentage of subjects able to complete the neoadjuvant portion of the study on time with > 85% of the protocol-specified dose.

  2. Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities

    Time frame: Toxicities are evaluated every 2 weeks during neoadjuvant treatment and assessed once during the post-treatment follow-up period, up to 25 weeks.

    Toxicities are evaluated according to the Common Terminology Criteria for Adverse Events, version 3.0. Grade refers to the severity of the adverse event (AE). Generally, grade 1 = mild AE; grade 2 = moderate AE; grade 3 = severe AE; grade 4 = life-threatening or disabling AE; grade 5 = death related to AE.

Secondary outcomes

  1. Pathologic Response

    Time frame: At completion of neoadjuvant treatment period, up to 24 weeks.

    Pathologic response was assessed at time of definitive surgery, scheduled to occur 20-24 weeks after study treatment start. Pathologic complete response was defined as no invasive carcinoma in surgical specimen of breast, but residual ductal carcinoma in situ may be present. Pathologic partial response was defined as >= 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size. Stable disease was defined as < 50% decrease in sum of diameters in pathologic cancer size compared to pretreatment clinical size, and < 25% increase in sum of diameters.

  2. Clinical Response Prior to Surgery

    Time frame: Assessed every 2 weeks during neoadjuvant treatment and prior to definitive surgery, up to 23 weeks.

    Clinical response was assessed via physical exam every 2 weeks during neoadjuvant treatment and via imaging prior to definitive surgery. Clinical complete response was defined as no evidence of cancer in breast by exam or imaging. Clinical partial response was defined as >= 50 % reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging. Clinical stable disease was defined as < 50% reduction in sum of diameters to measurement of primary lesion compared to pretreatment by exam or imaging, and < 25% increase in sum of diameters.

  3. Left Ventricular Ejection Fraction (LVEF)

    Time frame: At screening, prior to cycle 5, prior to surgery, and then during follow-up at Month 6, 12, 24, and 36

    LVEF was assessed by echocardiogram (ECHO) or multigated angiogram (MUGA) during neoadjuvant treatment and during follow-up.

  4. Progression-free Survival (PFS)

    Time frame: PFS was measured from day 1 of treatment until time of progression or death, whichever comes first, assessed up to 48 months.

    PFS is defined as the duration of time from start of treatment to time of progression or death, whichever comes first.

  5. Overall Survival (OS)

    Time frame: Measured from day 1 of treatment until time of death, assessed up to 48 months.

    Overall survival is defined as the time from treatment start until death from any cause. The median overall survival time is used to measure OS.

Sponsors and collaborators

Lead sponsor

Accelerated Community Oncology Research Network

Other

Collaborators

  • Aventis Pharmaceuticals

Registry information

Official study title

Pilot Trial of Sequential Dose-Dense Neoadjuvant Chemotherapy Plus Herceptin in HER2 Positive Stage II-III Breast Cancer Patients

Important dates

Study start
2005
Primary completion
2011
Study completion
2011
First posted
Dec 29, 2005
Registry last updated
Mar 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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