Phase II study of Neo-adjuvant chemotherapy with letrozole in patients with estrogen receptor positive/HER-2 negative breast cancer

Not Applicable

Active, not recruiting

• Conditions: Neoplasms

• Registration Number: KCT0008323
• Lead Sponsor: ational Cancer Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 April 2023

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

1 Locally advanced breast cancer patients with histological confirmation
2 Age =19 and =70
3 ER or PR positive, cT2N0 or cTx/N+ M0 (ER-positive =1% nuclear staining by immunohistochemistry , Allred score=3 )
4. Histological specimen (FFPE) should be present at diagnosis, and when examined from a different hospital, slides for ER, PR, HER2, and KI67 immunohistochemistry analysis as well as 5 unstained slides need to be present
5. Patients has hitologically and/or cytologically confirmed diagnosis of HER2-negative breast cancer
6 Patients with at least one measurable lesion by RECIST 1.1 from the images
7. Women of childbearing age should agree to proper contraception during the trial period (from the beginning until a few hours or a few days after the last administration of drugs considering half-life)
8 Patients with ECOG activity of 0,1, or 2
9 Patients with proper organ functions (attachment A)
10 Patients who signed the consent form

Exclusion Criteria

1. Patients with inflammatory breast cancer
2. Patients with bliateral breast cancer
3.Patients with stroke including transient ischemic attack, pulmonary artery thrombosis or deep vein thrombosis untreated within 6 months: study participation is available when there are no symptoms after the administration of therapeutic anticoagulant for 6 weeks or longer within 6 months
4. Patients with a history of previous malignant tumor. However, the following patients are exempted from the exclusion criteria
4.1 Patients with 3 years of disease free survival with malignant tumor different from the current tumor
4.2 Patients with skin tumor excluding melanoma that had complete resection
4.3 Patients with early gastric cancer that had radical resection
5.Patients with differentiated thyroid cancer of less than 1 cm
6. Patients whose ejection fraction is less than 55% in the MUGA scan /EchoCG
7. Patients without properly conserved tissue samples for diagnostic histological analysis (5 unstained slides excluding ER, PR, HER2, KI67)
8. Patients with clinically significant gastrointestinal bleeding – including but not limited to following conditions
8.1 Active peptic ulcer
8.2 Inflammatory intestinal disease
8.3 Patients with other gastrointestinal disease with a risk of perforation, gastrointestinal perforation or fistula, or a history of intraperitoneal abscess
9. Patients who cannot be administered with anthracycline due to other heart disease
10. Patients with clinically significant gastrointestinal malabsorption – including but not limited to the following conditions
10.1 Malabsorption syndrome
10.2 History of receiving major resection on stomach or small intestine
11 Corrected QT interval of ECG > 480 msec
12 Patients who have experienced the following cardiovascular abnormalities within the past 6 months
12.1 Patients who received coronary angioplasty or stent insertion
12.2 Acute myocardial infarction
12.3 Unstable angina
12.4 Patients who received coronary artery bypass surgery
12.5 Patients with symptomatic peripheral arterial disease
13 NYHA class III or IV congestive heart failure (Attachment B)
14 Uncontrolled hypertension (systolic blood pressure =140 mmHg or diastolic blood pressure =90 mmHg)
15 Patients who had a major surgery or trauma, and/or unhealed injury, fracture, and ulcer within 28 days before the administration of the first test drug: manipulations such as catheter insertion are not included in a major surgery
16 Acute hemorrhage or hemorrhagic tendency
17 Patients with a risk of pulmonary hemorrhage due to a lesion in the airway or a lesion invading the major pulmonary arteries; patients can participate in the trial when the tumor is in contact with blood vessels but has not invaded
18 Patients with protruding lesions in the main bronchi and lobar bronchi are excluded. Patients with lesions in the segmental bronchi can participate in the trial
19 Patients who recently had hemoptysis (within 8 weeks of the first administration of test drugs, ½ teaspoon of hemoptysis)
20 Administration of non-tumor clinical trial drug within 30 days of the first administration of test drugs or within 5 times of drug half-life
21 Pregnant women

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified