Randomized Phase II Study of Docetaxel (T) with or without Capecitabine (X) as Neoadjuvant Chemotherapy in Female Patients with Operable Breast Cancer Who were not Observed Disease Progression after 4 cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) (OOTR N003)

Randomized Phase II Study of Docetaxel (T) with or without Capecitabine (X) as Neoadjuvant Chemotherapy in Female Patients with Operable Breast Cancer Who were not Observed Disease Progression after 4 cycles of 5-Fluorouracil, Epirubicin and Cyclophosphamide (FEC) (OOTR N003) - Randomized Phase II Study of Docetaxel (T) with or without Capecitabine (X) as Neoadjuvant Chemotherapy in Operable Breast Cancer Patients Who were not Observed Disease Progression after FEC (OOTR N003)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-C000000322

Enrollment

500

Registered

2006-02-10

Start date

2005-12-01

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

Operable breast cancer

Interventions

5-fluorouracil, epirubicin, cyclophosphamide (FEC) followed by docetaxel (T) 5-fluorouracil, epirubicin, cyclophosphamide (FEC) followed by docetaxel, capecitabine (TX)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: T1C-3 N0 M0(>1cm) / T1-3 N1 M0} No prior treatment for breast cancer ECOG performance status (PS) 0-1 Adequate organ funtion signed a Patients Informed Consent Form

Exclusion criteria

Exclusion criteria: Male History of drug hypersensitivity Uncontrolled medical condition Significant interstitial pneumonia or pulmonary fibrosis by CT scan or x-ray Suspected of infection with fever Symptomatic Varicella Requiring treatment of pleural or pericardial effusions Severe edema Severe peripheral neuropathy Requiring treatment with the steroid is a necessity beforehand Severe psychiatric disorders Inflammatory breast cancer

Design outcomes

Primary

Measure	Time frame
Pathologic response (pCR rate)	—

Secondary

Measure	Time frame
Toxicity Clinical response Frequency of breast conservation surgery Frequency of axillary lymph node conservation surgery Disease-free survival Overall survival	—

Countries

Japan,Asia(except Japan)

Contacts

Public ContactShinji Ohno

The Cancer Institute Hospital Of JFCR (moved from National Hospital Organization Kyushu Cancer Cente Breast Oncology Center

sohno@nk-cc.go.jp03-3520-0111

Outcome results

None listed

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