NCT00432172

Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients

"A Randomized Multicenter Phase II Trial to Evaluate the Effectiveness of Selective Neoadjuvant Treatment According to Immunohistochemical Subtype for HER2 Negative Breast Cancer Patients"

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Spanish Breast Cancer Research Group · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label study that includes two substudies of random distribution. First,a sample of the primary tumor will be obtained and will be analyzed by an immunohistochemical technique to determine several markers.Depending on the expression of these markers, the patients will be characterize as group 1 (Luminal A phenotype) or group 2 (Basal phenotype) and a random assignment will be performed to standard or experimental treatment.

Detailed description

Group 1 (Luminal A): * Standard treatment: Epirubicin (E) 90 mg/ m2 intravenous (iv) in combination with Cyclophosphamide (C) 600 mg/ m2 iv every 21 days for 4 cycles, followed by docetaxel (D)100 mg/m2 iv every 21 days for 4 cycles. EC x 4 -\> D x 4 * Selective treatment: Postmenopausal patients: exemestane x 6 months; Premenopausal patients: goserelin x 6 months + exemestane x 6 months Group 2 (Basal): * Standard treatment: EC x 4 -\> D x 4 * Selective treatment: E 90 mg/ m2 iv in combination with C 600 mg/ m2 iv every 21 days for 4 cycles, followed by D (75 mg/m2) and carboplatin (Cb) (area under the curve = 6 mg/mL) iv every 21 days for 4 cycles. EC x 4 -\> DCb x 4

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Epirubicin
DRUG	Cyclophosphamide
DRUG	Docetaxel
DRUG	Exemestane
DRUG	Goserelin
DRUG	Carboplatin

Timeline

• Start date: 2007-04-24
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2007-02-07
• Last updated: 2023-04-03
• Results posted: 2019-07-17

Locations

12 sites across 1 country: Spain