A Phase II study of Neoadjuvant chemotherapy in Docetaxel and Cyclophosphamide(TC therapy) with Operable HER2 Negative breast cancer

A Phase II study of Neoadjuvant chemotherapy in Docetaxel and Cyclophosphamide(TC therapy) with Operable HER2 Negative breast cancer - A Phase II study of Neoadjuvant chemotherapy in Docetaxel and Cyclophosphamide(TC therapy) with Operable HER2 Negative breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000013261

Enrollment

Registered

2014-02-28

Start date

2012-08-01

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

Administrate 4 cycles of TC therapy(Docetaxel and Cyclophosphamide). Operation is to be performed after chemotherapy. nab-Paclitaxel(260mg/m2) intravenously on day 1 of each 3-weeks. FEC(5-Flu

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) Female primary breast cancer patients who are diagnosed as invasive breast cancer by needle biopsy or tissue biopsy. Resectable primary breast cancer (T1c-3 N0-1 M0) and tumor size is 7 cm or smaller. 2)Age between 20 to 70 years old 3)ECOG performance status (PS): 0-1 4)No previous treatments for breast cancer such as chemotherapy, hormone therapy, molecular target therapy, radiotherapy and immunotherapy. 5)Results from a laboratory test meet the following: a)Leukocyte count is >=3000/mm3 or b)Neutrophil count is >=2000/mm3 c)Hemoglobin >=9.0g/dL d)Platelet >=100 000/mm3 e)AST and ALT <=x 2.0 of upper limit of normal (ULN) f)Bilirubin (total bilirubin or direct bilirubin) <=1.5 of ULN g)Serum creatinine <=x 1.5 of ULN h)Baseline left ventricular ejection fraction (LVEF) is >=60% measured by echocardiography or MUGA scan. 6)Signed written informed consent

Exclusion criteria

Exclusion criteria: 1)Poorly controlled complication (malignant hypertension, myocardial infarction , congestive heart failure, bleeding). 2)Multiple primary cancer 3)Synchronous bilateral breast cancer 4)Interstitial pneumonia and pulmonary fibrosis diagnosed by chest X-rays or CT scan. 5)Women who are pregnant, lactating or with childbearing potential 6)Hypersensitivity to any agents necessary in the planned treatment. 7)Serious peripheral neuropathy or serious edema 8)Pleural effusion or cardiac effusion which requires treatment 9)Complication which requires prior treatment with corticosteroid 10)Suspected infection 11)Ineligible based on decision of an investigator

Design outcomes

Primary

Measure	Time frame
Pathological complete response rate	—

Secondary

Measure	Time frame
(1) Safety, adverse events (2) Overall response rate (3) Breast conserving rate	—

Countries

Japan

Contacts

Public ContactKatsuhiko Nakatsukasa

Kyoto Prefectural University of Medicine Endocrine & Breast Surgery

kacchan@koto.kpu-m.ac.jp075-251-5534

Outcome results

None listed

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