Primary systemic therapy of nab-paclitaxel in breast cancer patients

Primary systemic therapy of nab-paclitaxel in breast cancer patients - PINC-BC study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007724

Enrollment

Registered

2012-04-10

Start date

2012-02-01

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

4 cycles of FEC followed by 4 cycles of Nab-paclitaxel FEC:Epi 100mg/m2 and CPA 500mg/m2 and 5-FU 500mg/m2,day1 every 3weeks Nab-paclitaxel:260mg/m2,day1 every 3weeks

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Female patients with 1)Histologically confirmed invasive breast cancer 2)Lymph node metastases 3)Radical cure by operation and neoadjuvant chemotherapy 4)PS 0-2 5)Age>=20 6)No prior treatment for breast cancer 7)Required baseline laboratory data within 14days of registration Hb>=8.0g/dL WBC>=3000/mm3 and <=12000mm3 Neu>=2000/mm3 Plt>=100000/mm3 T-Bil<=1.5mg/dL AST,ALT<100IU/L Cre<=1.5mg/dL 8)Not clinically significant heart disease 9)Written informed consent

Exclusion criteria

Exclusion criteria: 1)Serious drug hypersensitivity 2)Other severe complications 3)Symptomatic brain metastasis 4)Active bleeding of digestive tract 5)Serious myeloablation,renal insufficciency,liver failure 6)Massive hydrothorax or ascites 7)Allergy of the Nab-paclitaxel,paclitaxelor albumin 8)Administration Pentostatin 9)Have any cances other than breast cancer 10)Active infection 11)Pregnant 12)Severe mental disorders 13)Administration steroid 14)Not suitable for participating in the study for any other reason

Design outcomes

Primary

Measure	Time frame
Pathological complete response rate	—

Secondary

Measure	Time frame
Responce rate,Histological therapeutic effect,breast conserving rate after preoperative chemotherapy,Safety	—

Countries

Japan

Contacts

Public ContactMasahiro Sakakibara

Graduate school of medicine,Chiba University Department of General Surgery

043-222-7171

Outcome results

None listed

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