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Neoadjuvant Doxorubicin and Cyclophosphamide Followed by Docetaxel and S-1 in Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Neoadjuvant Doxorubicin and Cyclophosphamide Followed by Docetaxel and S-1 in Breast Cancer


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of pathologic complete response

Safety Issue:

No

Principal Investigator

Joo Hyuk Sohn, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Severance Hospital

Authority:

Unspecified

Study ID:

CDR0000650694

NCT ID:

NCT00994968

Start Date:

July 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage III breast cancer
  • Breast Neoplasms

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