Doxorubicin Hydrochloride, Cyclophosphamide, Docetaxel, and S-1 Before Surgery in Treating Women With Stage II or Stage III Breast Cancer

NCT00994968 | Unknown Phase 2

• 2 other identifiers: CDR0000650694YONSEI-YCC-BR09-01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, docetaxel, and S-1, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying giving doxorubicin hydrochloride together with cyclophosphamide, docetaxel, and S-1 before surgery in treating women with stage II or stage III breast cancer.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage III breast cancer

Outcome Measures

Primary Outcomes (1)

• Rate of pathologic complete response

Secondary Outcomes (5)

• Safety and tolerability

• Rate of overall radiologic response

• Rate of breast-conserving procedure

• Disease-free survival

• Relevant pharmacogenomics and biomarker(s) which may be useful to predict any responses to the anticancer treatments

Interventions

cyclophosphamide DRUG

docetaxel DRUG

doxorubicin hydrochloride DRUG

tegafur-gimeracil-oteracil potassium DRUG

neoadjuvant therapy PROCEDURE

therapeutic conventional surgery PROCEDURE

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed invasive primary breast cancer * Clinical (radiologic) stage II or III disease * No T4d disease * No inflammatory breast cancer * ErbB2-negative disease OR patient cannot receive trastuzumab treatment * ErbB2-positive disease defined as either immunohistochemistry 3+, or FISH- or CISH-positive; immunohistochemistry 2+ is to be determined according to FISH or CISH results PATIENT CHARACTERISTICS: * Mobile * ECOG performance status 0-1 * Normal cardiac function (LVEF \> 50%) * Hemoglobin ≥ 10.0 g/dL * Absolute neutrophil count ≥ 1,500/μL * Platelet count ≥ 10 x 10\^4/μL * Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance ≥ 50 mL/min * Total bilirubin ≤ 1.5 times ULN * AST/ALT ≤ 2.5 times ULN * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Able to swallow tablet whole with water * No prior motor or sensory neurotoxicity CTCAE ≥ grade 2 * No other serious disease or medical condition * No uncontrolled or serious cardiovascular disease, including any of the following: * Myocardial infarction within the past 6 months * New York Heart Association class III or IV heart failure * Uncontrolled angina pectoris * Clinically significant pericardial disease * Cardiac amyloidosis * No history of symptomatic or therapy-requiring cardiac arrhythmia CTCAE grade 3 (e.g., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, uncontrolled atrial fibrillation) * No asymptomatic sustained ventricular tachycardia * History of atrial fibrillation or cardiac arrhythmia controlled by medication allowed * No uncontrolled infection, unstable peptic ulcer, uncontrolled diabetes, or any other contraindication to corticosteroid administration * No history of infection or any other serious medical event which may cause any functional injury in the affected patient and consequently, interfere with continuing the study treatment * No history of hypersensitivity to taxanes, fluorouracil, or S-1 * No significant gastrointestinal malfunction that will affect S-1 absorption * No history of other cancer within the past 5 years except properly treated carcinoma in situ of the uterine cervix or basal cell or squamous cell carcinoma of the skin * No severe psychological or neurological disorder or dementia that would preclude understanding of the informed consent * No psychological, social, family, or geographical condition, or difficult circumstance that would preclude follow-up or compliance with the protocol PRIOR CONCURRENT THERAPY: * No prior systemic treatment for this cancer (e.g., radiotherapy, chemotherapy, hormone therapy, or biological therapy) * No prior preoperative topical treatments (e.g., incomplete surgery or radiotherapy) for this cancer * No concurrent drug(s) that may potentially cause changes in the pharmacological activity of S-1 formulation, including any of the following: * Allopurinol * Phenytoin

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei Cancer Center at Yonsei University Medical Center

Seoul, South Korea

RECRUITING

Related Publications (1)

• Moon YW, Lee S, Park BW, Kim EK, Kim SI, Koo JS, Park S, Kim MJ, Chung HC, Kim JH, Sohn J. S-1 combined with docetaxel following doxorubicin plus cyclophosphamide as neoadjuvant therapy in breast cancer: phase II trial. BMC Cancer. 2013 Dec 6;13:583. doi: 10.1186/1471-2407-13-583.

  PMID: 24314307 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cyclophosphamide; Docetaxel; Doxorubicin; Neoadjuvant Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Diterpenes; Terpenes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Combined Modality Therapy; Therapeutics

Study Officials

• Joo Hyuk Sohn, MD, PhD

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 13, 2009
• First Posted: October 14, 2009
• Study Start: July 1, 2009
• Last Updated: October 29, 2010

Record last verified: 2009-10

Locations

KR (1)