A randomized phase II trial to investigate optimal duration (4 month versus 6 month) of preoperative endocrine therapy

A randomized phase II trial to investigate optimal duration (4 month versus 6 month) of preoperative endocrine therapy - PTEX46 Trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000005668

Enrollment

Registered

2011-05-30

Start date

2008-04-01

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

Four months internal use of aromatase inhibitor (exemestane) Six months internal use of aromatase inhibitor (exemestane)

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1) postmenopausal women with operable. 2) histologically confirmed, invasive ductal carcinoma 3) Clinical stage II-IIIA 4) ER+ and/or PgR+ 5) WHO performance status (PS) 0-1 6) No previous history of breast cancer treatment 7) Informed consent

Exclusion criteria

Exclusion criteria: 1) History of chemotherapy or endocrine therapy for breast cancer. 2) Receiving any drugs that may affect the sex hormone status.

Design outcomes

Primary

Measure	Time frame
clinical response(caliper)	—

Countries

Japan

Outcome results

None listed

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