A phase II neoadjuvant trial of concurrent trastuzumab and aromatase inhibitor in postmenopausal women with HER2-positive and hormone receptor-positive breast cancer.

A phase II neoadjuvant trial of concurrent trastuzumab and aromatase inhibitor in postmenopausal women with HER2-positive and hormone receptor-positive breast cancer. - A phase II neoadjuvant trial of concurrent trastuzumab and aromatase inhibitor in postmenopausal women with HER2-positive and hormone receptor-positive breast cancer.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007353

Enrollment

Registered

2012-02-22

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

Postmenopausal women with HER2-positive and hormone receptor-positive breast cancer.

Interventions

Letrozole is given daily at a dose of 2.5mg concomitantly with trastuzumab for 6 months before surgery. Trastuzumab is given with a loading dose of 8 mg/kg

subsequent doses are 6 mg/kg every three weeks for 8 cycles.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Histologically confirmed invasive breast cancer 2. ER and or PgR-positive, HER2-positive 3. Measurable disease 4. Stage I , II or III 5. Performance status 0 or 1 6. Untreated breast cancer 7. Meet the cirteria of baseline labolatory parameters as below. 1) WBC 3500/mm3 or more, 10000/mm3 or less, Plt 100,000/mm3 or more, Hb 10g/dl or more 2) T.Bil 1mg/dl or less, GOT 60 IU/L or less, GPT 60 IU/L or less 8. Written informed consent 9. Confirmed menopausal status. In case of prior hysterectomy, parameters of E2, LH and FSH are consistent with those of postmenopause status.

Exclusion criteria

Exclusion criteria: 1. Inflammatory breast cancer 2. Other active malignancies 3. History of cardiac infarction, valvular diseases of the heart and severe cardiac disfunction 4. Other medical conditions that could limit a patient's ability to undertake study therapy

Design outcomes

Primary

Measure	Time frame
clinical response rate, tumor reduction rate	—

Secondary

Measure	Time frame
pathological CR rate, adverse event, breast conserving rate, relapse free survival, Ki-67 index changes	—

Countries

Japan

Contacts

Public ContactHiromitsu Jinno

Keio University School of Medicine Department of Surgery

Outcome results

None listed

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