Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women

PREDICT TRIAL- Neoadjuvant Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women Expressing Hormonal Receptors ( ER and PR)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00237133

Acronym

PREDICT

Enrollment

112

Registered

2005-10-12

Start date

2003-03-31

Completion date

2009-01-21

Last updated

2017-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Advanced Breast Cancer

Keywords

Breast cancer,, Letrozole,, Hormonal receptors

Brief summary

Open-label Phase IV trial of Letrozole 2,5mg po/day for 120 days prior to surgery for patients with locally advanced breast in postmenopausal women expressing hormonal receptors ( ER and PR)

Interventions

DRUGLetrozole

1 tablet of Letrozole 2.5 mg orally adminnistered once a day

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Postmenopausal women 2. Primary locally invasive breast cancer 3. Histological confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with \> 10% positive malignant epithelial cells. 4. Post menopausal status 5. Tumor measurable by clinical examination, mammography and ultrasound

Exclusion criteria

1. Prior treatment with letrozole or tamoxifen. 2. Patients with bilateral breast tumors 3. Patients who are eligible for breast conserving surgery 4. Evidence of inflammatory breast cancer or distant metastasis. 5. Other concurrent malignant disease 6. Concomitant anti-cancer treatments such as chemotherapy Other protocol-defined

Design outcomes

Primary

Measure	Time frame
Safety and tolerability of Letrozole	frequency and severity of the clinical adverse events

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026