Multicenter phase II trial to Prevent Docetaxel-Induced Nail change using a Frozen Glove with docetaxel (T) and cyclophosphamide(C) as adjuvant chemotherapy for patients with high risk, node negative, early stage breast cancer: Tokai Breast Cancer Clinical Research Group (TBCRG) 03 trial

Multicenter phase II trial to Prevent Docetaxel-Induced Nail change using a Frozen Glove with docetaxel (T) and cyclophosphamide(C) as adjuvant chemotherapy for patients with high risk, node negative, early stage breast cancer: Tokai Breast Cancer Clinical Research Group (TBCRG) 03 trial - TBCRG03

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000000806

Enrollment

Registered

2007-09-01

Start date

2007-07-01

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

Frozen glove to prevent docetaxel-induced nail toxicities with right hand. Docetaxel 75 mg/m2 IV Day 1Cyclophosphamide 600 mg/m2 IV Day 1 Every 21 days X 4 CyclesUse standard premedication

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Patients with early stage breast cancer (M0) 2.High risk node negative patients 3.Age >20 years and < 70 years, 4.ECOG performance status 0-1 5.No more than 12 weeks after most recent surgery 6.Sufficient organ function 7.Signed informed consent 8.No heart disease

Exclusion criteria

Exclusion criteria: 1.As neoadjuvant and adjuvant therapy , treated hormone therapy and chemotherapy 2.HER2 / neu gene overexpressed or amplified 3.A history of whitlow and cold allergy 4.Bilateral breast cancer and Inflammatory breast cancer 5.Uncontrolled medical conditions 6.Hepatitis B 7.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 8.Sever infection 9.Peripheral neuropathy 10.Pleural or pericardial effusion requiring treatment 11.Pregnant or lactating women and women of child bearing potential not using contraception. 12.Grade2-4 Severe peripheral edema. 13.Significant interstitial pneumonia or pulmonary fibrosis by CT scan or X-ray 14.A history of hypersensitivity reaction to drugs formulated with Polysorbate 80 15.Severe psychiatric disorders 16.Patients judged by the investigator to be unfit to be enrolled into the study

Design outcomes

Primary

Measure	Time frame
Prevention of nail change by frozen glove	—

Secondary

Measure	Time frame
Safety, feasibility	—

Countries

Japan

Outcome results

None listed

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