Feasibility Phase 2 study of Dose-dense AC or EC followed by PTX for operable breast cancer

Feasibility Phase 2 study of Dose-dense AC or EC followed by PTX for operable breast cancer - Feasibility study of Dose-Dense therapy for early breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000022097

Enrollment

Registered

2016-04-28

Start date

2016-04-01

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

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. written informed consent 2. more than 20 y.o to 70y.o 3. ECOG PS 0-2 4. diagnosis of invasive breast cancer 5.HER2 negative 6. more than cN1 7. visceral function 8. LVEF more than 50%

Exclusion criteria

Exclusion criteria: 1. distant metastasis 2. pregnancy or breast feeding 3. history of drug allergy 4. active infection 5. uncontrollable psychosis

Design outcomes

Primary

Measure	Time frame
pathological Complete Response rate	—

Secondary

Measure	Time frame
safety (morbidity rate of febrile neutropenia, rate of accomplishment) overall response rate toxicity profile Relative Dose Intensity(RDI)	—

Countries

Japan

Contacts

Public ContactTadahiko Shien

Okayama University Hospital breast surgery

yshien@md.okayama-u.ac.jp086-235-7265

Outcome results