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

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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



- 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.


- 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


- 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


- 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

- 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


- 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:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Rate of pathologic complete response

Safety Issue:


Principal Investigator

Joo Hyuk Sohn, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Severance Hospital



Study ID:




Start Date:

July 2009

Completion Date:

Related Keywords:

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