A Phase II study of docetaxel (T) and cyclophosphamide(C) as adjuvant chemotherapy for patients with high risk, node negative, early stage breast cancer

A Phase II study of docetaxel (T) and cyclophosphamide(C) as adjuvant chemotherapy for patients with high risk, node negative, early stage breast cancer - JECBC04

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000493

Enrollment

Registered

2006-10-01

Start date

2006-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Docetaxel 75 mg/m2 IV Day 1 Cyclophosphamide 600 mg/m2 IV Day 1 Every 21 days X 4 Cycles Use standard premedication

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Patients with Stage I, II, or operable Stage III invasive breast cancer Node negative early stage breast cancer (T1-4, N0, M0) High risk node negative patients will be defined as patients with negative (N0) lymph node involvement , and at least 1 of the following factors : Tumor size >2cm2 Histologic and / or nuclear grade2-3 Age <35 years Presence of peritumoral vascular invasion HER2 / neu gene overexpressed or amplified Estrogen receptor and progesterone receptor status negative Complete surgical excision of the primary tumor Age >20 years and < 70 years ECOG performance status 0-1 No more than 12 weeks after most recent surgery Signed informed consent Sufficient organ function

Exclusion criteria

Exclusion criteria: Male A history of other malignancies within the last 5 years except for adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix Bilateral breast cancer Inflammatory breast cancer A history of hypersensitivity reaction to drugs formulated with Polysorbate 80 Uncontrolled medical conditions (e.g., malignant hypertension, congestive heart failure, renal failure, myocardial infarction in the previous 6 months, treatment required arrhythmia, infection, hemorrhage) Grade 2-4 peripheral neuropathy Pleural or pericardial effusion requiring treatment Severe peripheral edema. Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray Patients who require concurrent treatment by corticosteroids except for premedication. Evere psychiatric disorders Pregnant or lactating women Patients judged by the investigator to be unfit to be enrolled into the study Prior chemotherapy or radiation therapy for other cancer within 3 years including neo-adjuvant chemotherapy for locally advanced breast cancer.

Design outcomes

Primary

Measure	Time frame
Safety, feasibility	—

Countries

Japan

Contacts

Public ContactToshio Tabei

JECBC Saitama Cancer Center

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026