A Randomized, Open Label Study to Compare the Complete Pathological Response Rate Achieved With 4 Combinations of Herceptin, Docetaxel and Pertuzumab in Patients With Locally Advanced, Inflammatory or Early Stage HER2 Positive Breast Cancer

Not Applicable

• Conditions: -C50 Malignant neoplasm of breast; Malignant neoplasm of breast; C50

• Registration Number: PER-121-08
• Lead Sponsor: PRODUCTOS ROCHE Q.F.S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-12-05
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 9

Inclusion Criteria

• Women with locally advanced, inflammatory or early, unilateral and invasive breast cancer histologically confirmed.
• Primary tumor> 2 cm in diameter.
• HER2 positive breast cancer confirmed by the central laboratory. The tumors must be HER2 + 4- + in IHC or FISH / CISH + (FISH / CISH is mandatory in HER2 ++ tumors).
• Availability of FFPE tissue for confirmation of the status of HER2 in the central laboratory (the FFPE tumor tissue will be used later to assess the status of biomarkers).
• Age> 18 years.
• Baseline LVEF> 55% (valued in echocardiography or MUGA).
• ECOG functional status • If the patient has undergone a major surgery intervention unrelated to the study, a minimum of 4 weeks must have elapsed and she must have fully recovered.

Exclusion Criteria

• metastatic disease (Stage IV) or bilateral breast cancer;
• previous anticancer therapy or radiotherapy for any malignancy;
• other malignancy, other than cancer in situ of the cervix, or basal cell cancer;
• insulin-dependent diabetes;
• clinically relevant cardiovascular disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified