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Adjuvant chemotherapy combined with docetaxel and cyclophosphamide for Japanese breast cancer patients without lymph node metastasis or with three and under lymph node metastasis.

Adjuvant chemotherapy combined with docetaxel and cyclophosphamide for Japanese breast cancer patients without lymph node metastasis or with three and under lymph node metastasis. - Adjuvant chemotherapy combined with docetaxel and cyclophosphamide for Japanese breast cancer patients. (GBCRG-2surg-01)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002310
Enrollment
90
Registered
2009-08-31
Start date
2009-07-01
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

four cycles of therapy, administered every 3 weeks. Docetaxel (75 mg/m2) and Cyclophosphamide (600 mg/m2) are administered by intravenous infusion on day 1 in eacn cycle.

Sponsors

Gunma Breast Cancer Research Group 2 surgery
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1) Histologically diagnosed breast cancer without lymph node metastasis or with three and under lymph node metastasis. 2)Age 20 to 70 years 3)ECOG PS 0 to 2 4)Previous endocrine therapy or chemotherapy for breast cancer. 5)Required baseline laboratory parameters 6)Without severe complications,ischemia attack, uncontrolled congestive heart failure 7)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Patients who received previous endocrine therapy or chemotherapy 2)Severe drug allergic history 3)Inflammatory breast cancer 4)Bilateral breast cancer in same time 5)Severe complications 6)Active double cancer 7)Inflammation with fever up 8)Neurological problem 9)Pleural effusion or pericardial effusion 10)Symptomatic brain metastasis 11)Pregnancy 12)Severe edema 13)Interstitial lung disease, pulmonary fibrosis 14)Psychiatric disease 15)Doctors decision for excluion 16)Low risk in St. Gallen Conferences 2007 17)16 weeks or more after operation

Design outcomes

Primary

MeasureTime frame
Safety completion rate

Secondary

MeasureTime frame
Disease free survival Overall survival

Countries

Japan

Contacts

Public ContactNana Rokutanda

Gunma Breast Cancer Research Group 2 surgery (GBCRG-2surg) 01 Secretariat Division (Department of Thoracic Visceral Organ Surgery , Gunma University Graduate Scho

nana.rokutanda@gmail.com027-220-8245

Outcome results

None listed

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