Docetaxel, Epirubicin, and Cyclophosphamide With or Without Trastuzumab in Treating Women With Locally Advanced Breast Cancer That Can Be Removed By Surgery

NCT00398489 | Unknown Phase 2

• 4 other identifiers: CDR0000516034KRDI-TUM-HED-324-PAE-0090-IEU-20634EUDRACT-2005-000967-24
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 5

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, epirubicin, and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy with or without monoclonal antibody therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving docetaxel, epirubicin, and cyclophosphamide with or without trastuzumab works in treating women with locally advanced breast cancer that can be removed by surgery.

Conditions

Breast Cancer

Keywords

stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage II breast cancer; inflammatory breast cancer

Outcome Measures

Primary Outcomes (4)

• Rate of pathologic complete remission (pCR) after neoadjuvant therapy comprising docetaxel and trastuzumab (Herceptin®) in women with locally advanced, HER2-positive, operable breast cancer

• Rate of pCR after neoadjuvant docetaxel in women with locally advanced, HER2-negative, operable breast cancer

• Tolerability of treatment as measured by the nature and frequency of adverse events in women with HER2-positive or HER2-negative disease

• Identification of predictive markers

Secondary Outcomes (6)

• Rate of breast conserving therapy versus mastectomy in comparison to preoperative evaluation

• Correlation of clinical/sonographical response with pathological response, including lymph node status

• Rate of clinical complete remission (cCR) after neoadjuvant therapy comprising docetaxel and trastuzumab in women with locally advanced, HER2-positive, operable breast cancer

• Rate of cCR after neoadjuvant docetaxel in women with locally advanced, HER2-negative, operable breast cancer

• Disease-free survival after 2.5 and 5 years

Interventions

trastuzumab BIOLOGICAL

anastrozole DRUG

cyclophosphamide DRUG

docetaxel DRUG

epirubicin hydrochloride DRUG

goserelin acetate DRUG

tamoxifen citrate DRUG

adjuvant therapy PROCEDURE

conventional surgery PROCEDURE

neoadjuvant therapy PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed primary carcinoma of the breast by core biopsy * Solitaire or multifocal disease, defined as tumor manifestations within a quadrant or distance between tumor manifestations measured bilaterally \< 4 cm, respectively * No multifocal primary tumor, defined as tumor manifestations in different quadrants or distance between tumor manifestations ≥ 4 cm * Locally advanced, operable disease * Primary tumor ≥ 2 cm by clinical examination or imaging (i.e., mammogram, MRI, or ultrasound) * Inflammatory breast cancer with bidimensionally measurable lesion, independent of nodal status, allowed * HER2 status meeting 1 of the following criteria: * HER2-positive disease * 3+ by immunohistochemistry (IHC) and/or positive by fluorescence in situ hybridization (FISH) * HER-2 negative disease * 0 or 1+ by IHC OR 2+ by IHC and negative by FISH * No distant metastases by clinical or imaging diagnosis * No prior breast cancer * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Pre- or post-menopausal * ECOG performance status 0-2 * Platelet count ≥ 100,000/mm\^3 * Neutrophil count ≥ 1,500/mm\^3 * Hemoglobin ≥ 10 g/dL * ALT and AST ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 2.5 times ULN * Creatinine ≤ 1.5 times ULN * Bilirubin normal (unless due to clearly documented Gilbert's syndrome) * Not pregnant or nursing * Negative pregnancy test (for premenopausal women or women with a postmenopausal status for \< 1 year) * Fertile patients must use effective contraception * Adequate organ function for cytotoxic chemotherapy * No known hypersensitivity reaction to the study agents or incorporated substances * No known allergy or severe reactions to trastuzumab or its constituents (for patients with HER2-positive disease) * No preexisting motor or sensory neuropathy ≥ grade 2 * No other invasive malignancy within the past 5 years that would preclude study compliance or affect the interpretation of study results * LVEF ≥ 55% by MUGA or echocardiography * No other serious illness or medical condition, including any of the following: * New York Heart Association class II-IV congestive heart failure * History of documented congestive heart failure * Unstable angina pectoris * Myocardial infarction within the past 12 months * Uncontrolled hypertension (i.e., systolic blood pressure \[BP\] \> 180 mm Hg or diastolic BP \> 100 mm Hg) * Clinically significant valvular heart disease * High-risk, uncontrolled arrhythmias * Dyspnea at rest due to malignant or other disease * Condition that requires supportive oxygen therapy * Active serious uncontrolled infections * Uncontrolled diabetes PRIOR CONCURRENT THERAPY: * No prior systemic therapy for cancer * No prior trastuzumab (Herceptin\^®) (for HER2-positive patients) * No other concurrent anticancer therapy * No other concurrent investigational drugs * No concurrent immunosuppressive therapy * No concurrent sex hormones * No concurrent corticosteroids unless for premedication * No concurrent bisphosphonates during active treatment with chemotherapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Technical University of Munich: lead

Study Sites (5)

Klinikum Bayreuth

Bayreuth, D 95448, Germany

Location

Universitaetsfrauenklinik - Koeln

Cologne, D-50391, Germany

Location

Klinikum Deggendorf

Deggendorf, 94469, Germany

Location

Klinikum der Friedrich-Schiller Universitaet Jena

Jena, D-07743, Germany

Location

Klinikum Rechts Der Isar - Technische Universitaet Muenchen

Munich, D-81675, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms; Inflammatory Breast Neoplasms

Interventions

Trastuzumab; Anastrozole; Cyclophosphamide; Docetaxel; Epirubicin; Goserelin; Tamoxifen; Chemotherapy, Adjuvant; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Oligopeptides; Nerve Tissue Proteins; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Combined Modality Therapy; Therapeutics; Drug Therapy

Study Officials

• Stefan Paepke, MD

  Technical University of Munich

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 9, 2006
• First Posted: November 10, 2006
• Study Start: October 1, 2006
• Last Updated: November 9, 2010

Record last verified: 2008-09

Locations

DE (5)