Exploratory study to determine predictive factors of effectiveness of nab-paclitaxel in breast cancer (Expect study)

Exploratory study to determine predictive factors of effectiveness of nab-paclitaxel in breast cancer (Expect study) - Exploratory study to determine predictive factors of effectiveness of nab-paclitaxel in breast cancer (Expect study)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009526

Enrollment

Registered

2012-12-11

Start date

2012-12-11

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

Nab-paclitaxel Nab-paclitaxel:100mg/m2 i.v weekly for 12 weeks

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Histologically confirmed Breast cancer 2.Clinical stage2-4 3.Has measurable region 4.Age >=20 and 80=< 5.No prior surgery, radiation, chemotherapy and endcrinethrapy 6.Presence of measurable lesion 7.Required baseline laboratory parameters (within 14 days before registration): Hb more than 9.0g/dl WBC >= 3000 /mm3 and <= 12,000 /mm3 Neu >= 1500 / mm3 Plt >= 75,000/mm3 T-Bil <= 2.5 times ULM AST<= ULNx2.5 ALT<= ULNx2.5 Creatinine <=1.5 mg/dL 8.Performance status 0-2 9.Written IC

Exclusion criteria

Exclusion criteria: 1.History of hypersensitivity reaction 2.HER2 positive confirmed by IHC or FISH 3. Active another cancer 4.Other severe complications, such as infection, diarrhea, intestinal tract paralysis, ileus, uncontrollable diabetes,uncontrollable angina, myocardial infarction within 6 months, heart failure, Pulmonary fibrosis or interstitial pneumonia, cerebrovascular disorder 5.With symptomatic brain cancer 6.With mental disorder which become problem on clinical practice 7.With serious bone marrow suppression, a renal damage, a liver damage 8.With serious pleural effusion or ascites 9.With infection or febrile infection 10. Hypersensitivity reaction of nab-paclitaxel or paclitaxel 11.During administration of flucytosine, phenytoin, warfarin potassium 8. Physician judged improper to entry this trial

Design outcomes

Primary

Measure	Time frame
Correlativity of the biomarker and Response Rate	—

Secondary

Measure	Time frame
Rasponse rate,Pathological response rate, Safty	—

Countries

Japan

Contacts

Public ContactYASUSHI OKAMOTO

Toho University School of Medicine, Medical Center, Ohashi Hospita Breast cancer center

yok195@med.toho-u.ac.jp03-3468-1251

Outcome results

None listed

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