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

NCT00270894 | Completed Phase 2 Results

• 1 other identifier: ACORN ALSSNBC0401
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

Brief Summary

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)

Conditions

Breast Neoplasm

Keywords

neoadjuvant chemotherapy; HER2 positive breast cancer; stage II - III breast cancer

Outcome Measures

Primary Outcomes (2)

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

  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.

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

• Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities

  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.

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

Secondary Outcomes (5)

• Pathologic Response

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

• Clinical Response Prior to Surgery

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

• Left Ventricular Ejection Fraction (LVEF)

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

• Progression-free Survival (PFS)

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

• Overall Survival (OS)

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

Study Arms (1)

Neoadjuvant therapy

EXPERIMENTAL

Neoadjuvant therapy will consist of epirubicin (100 mg/m\^2) + cyclophosphamide (600 mg/m\^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m\^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg \[loading dose\] once then 4 mg/kg \[maintenance dose\]) every 2 weeks for 4 treatments.

Drug: epirubicin; Drug: cyclophosphamide; Drug: docetaxel; Drug: trastuzumab

Interventions

epirubicin DRUG

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

Also known as: Ellence®

Neoadjuvant therapy

cyclophosphamide DRUG

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

Also known as: Cytoxan

Neoadjuvant therapy

docetaxel DRUG

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

Also known as: Taxotere®

Neoadjuvant therapy

trastuzumab DRUG

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

Also known as: Herceptin®

Neoadjuvant therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Accelerated Community Oncology Research Network: lead
• Aventis Pharmaceuticals: collaborator

Study Sites (7)

Advanced Medical Specialties

Miami, Florida, 33176, United States

Location

Augusta Oncology Associates

Augusta, Georgia, 30901, United States

Location

Cental Georgia Cancer Care

Macon, Georgia, 31201, United States

Location

Northwest Georgia Oncology Centers, PC

Marietta, Georgia, 30060, United States

Location

Hematology Oncology Centers of the Northern Rockies, PC

Billings, Montana, 59101, United States

Location

Arena Oncology Associates

Great Neck, New York, 11021, United States

Location

The West Clinic

Memphis, Tennessee, 38120, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Epirubicin; Cyclophosphamide; Docetaxel; Trastuzumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Vice President of Scientific Affairs
• Organization: Accelerated Community Oncology Research Network, Inc.

mwalker@acorncro.com

901-435-5570

Study Officials

• Lee S Schwartzberg, MD, FACP

  Accelerated Community Oncology Research Network, Inc. (ACORN)

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2005
• First Posted: December 29, 2005
• Study Start: November 1, 2005
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 20, 2012
• Results First Posted: March 12, 2012

Record last verified: 2012-03

Locations

US (7)