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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00994968
First received: October 13, 2009
Last updated: October 28, 2010
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: cyclophosphamide
Drug: docetaxel
Drug: doxorubicin hydrochloride
Drug: tegafur-gimeracil-oteracil potassium
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Neoadjuvant Doxorubicin and Cyclophosphamide Followed by Docetaxel and S-1 in Breast Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Rate of pathologic complete response [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability [ Designated as safety issue: Yes ]
  • Rate of overall radiologic response [ Designated as safety issue: No ]
  • Rate of breast-conserving procedure [ Designated as safety issue: No ]
  • Disease-free survival [ Designated as safety issue: No ]
  • Relevant pharmacogenomics and biomarker(s) which may be useful to predict any responses to the anticancer treatments [ Designated as safety issue: No ]

Estimated Enrollment: 49
Study Start Date: July 2009
Detailed Description:

OBJECTIVES:

Primary

  • Determine the rate of pathologic complete response in women with previously untreated stage II or III breast cancer treated with neoadjuvant doxorubicin hydrochloride and cyclophosphamide followed by docetaxel and S1.

Secondary

  • Determine the safety and tolerability of this regimen in these patients.
  • Determine the rate of overall radiologic response in these patients.
  • Determine the rate of breast-conserving procedures in these patients.
  • Determine the disease-free survival of these patients.
  • Investigate the relevant pharmacogenomics and biomarker(s) which will be useful to predict any responses to the anticancer treatments.

OUTLINE: Patients receive neoadjuvant doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for up to 4 courses. Patients then receive docetaxel IV over 1 hour on day 1 and oral S-1 on days 1-14. Treatment repeats every 3 weeks for 4 courses. Two to four weeks later, patients undergo surgery to remove the tumor (either breast-conserving procedures or mastectomy). Patients may then undergo radiotherapy and receive endocrine therapy.

  Eligibility

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

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
  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: NCT00994968

Locations
Korea, Republic of
Yonsei Cancer Center at Yonsei University Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Joo Hyuk Sohn, MD, PhD    82-2-2228-8130      
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Joo Hyuk Sohn, MD, PhD Severance Hospital
  More Information

Additional Information:
No publications provided by National Cancer Institute (NCI)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00994968     History of Changes
Other Study ID Numbers: CDR0000650694, YONSEI-YCC-BR09-01
Study First Received: October 13, 2009
Last Updated: October 28, 2010
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage II breast cancer
stage III breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Liposomal doxorubicin
Docetaxel
Doxorubicin
Tegafur
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
Antimetabolites, Antineoplastic
Antimetabolites
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on July 31, 2014