Doxorubicin Hydrochloride, Cyclophosphamide, Docetaxel, and S-1 Before Surgery in Treating Women With Stage II or Stage III Breast Cancer
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
cyclophosphamide
docetaxel
doxorubicin hydrochloride
tegafur-gimeracil-oteracil potassium
neoadjuvant therapy
therapeutic conventional surgery
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage II breast cancer, stage III breast cancer
Eligibility 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
Sites / Locations
- Yonsei Cancer Center at Yonsei University Medical CenterRecruiting
Outcomes
Primary Outcome Measures
Rate of pathologic complete response
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00994968
Brief Title
Doxorubicin Hydrochloride, Cyclophosphamide, Docetaxel, and S-1 Before Surgery in Treating Women With Stage II or Stage III Breast Cancer
Official Title
Neoadjuvant Doxorubicin and Cyclophosphamide Followed by Docetaxel and S-1 in Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Unknown status
Study Start Date
July 2009 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Yonsei University
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage II breast cancer, stage III breast cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
49 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
tegafur-gimeracil-oteracil potassium
Intervention Type
Procedure
Intervention Name(s)
neoadjuvant therapy
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Primary Outcome Measure Information:
Title
Rate of pathologic complete response
Secondary Outcome Measure Information:
Title
Safety and tolerability
Title
Rate of overall radiologic response
Title
Rate of breast-conserving procedure
Title
Disease-free survival
Title
Relevant pharmacogenomics and biomarker(s) which may be useful to predict any responses to the anticancer treatments
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joo Hyuk Sohn, MD, PhD
Organizational Affiliation
Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yonsei Cancer Center at Yonsei University Medical Center
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joo Hyuk Sohn, MD, PhD
Phone
82-2-2228-8130
12. IPD Sharing Statement
Citations:
PubMed Identifier
24314307
Citation
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.
Results Reference
derived
Learn more about this trial
Doxorubicin Hydrochloride, Cyclophosphamide, Docetaxel, and S-1 Before Surgery in Treating Women With Stage II or Stage III Breast Cancer
We'll reach out to this number within 24 hrs