None listed
Conditions
Interventions
Group A Type of group
Trastuzumab 8mg/kg iv loading dose, followed by 6mg/kg iv 3-weekly + Docetaxel 75mg/m2 iv escalating to 100mg/m2 iv 3-weekly
Group name:Group D Type of group
Docetaxel 75mg/m2 iv escalating to 100mg/m2 iv 3-weekly + Pertuzumab 840mg iv loading dose, followed by 420mg iv 3-weekly
Sponsors
PRODUCTOS ROCHE Q.F.S.A.,
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
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 <I. • 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants with invalid/missing pCR assessments were defined as non-responders Measure:Percentage of Participants Achieving Pathological Complete Response (pCR) Timepoints:Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4 ; Outcome name:pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Based on the type of breast cancer participants were categorized as those with 1. Operable breast cancer, 2. Inflammatory breast cancer and 3. Locally advanced breast cancer. Participants with invalid/missing pCR assessments were defined as non-responders. Measure:Percentage of Participants Achieving pCR by Breast Cancer Type Timepoints:Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4 ; Outcome name:pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Participants were classified as Estrogen and/or Progesterone positive (+ve), Estrogen and/or Progesterone negative (-ve) or receptor status unknown. Participants with invalid/missing pCR assessments were defined as non-responders. Measure:Percentage of Participants Achieving pCR by Hormone Receptor Status Timepoints:Approximately 4 months from randomization following surgery or early withdrawal, whichever occurred first (Surgery was performed within 2 weeks after Cycle 4 ; Outcome name:pCR was defined as an absence of invasive neoplastic cells at microscopic examination of the tumor remnants after surgery following primary systemic therapy. Ly | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Tumor assessments were made based upon the Response Evaluation Criteria in Solid Tumors (RECIST) criteria - version 1.0. The clinical response at each cycle up to the last assessment prior to surgery was derived for primary breast tumor using the following algorithm: CR: if measurement of 0 is noted at a given cycle as compared to baseline measurement which is greater than (>)0 at screening or cycle 1 Day 1; PR: if measurement is at least a 30 percent (%) decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD compared to baseline levels. PD: if lesion is at least a 20 % increase from measurements at baseline. Measure:Porcentaje de participantes que logran la mejor respuesta primaria del tumor (respuesta completa [CR], respuesta parcial [PR], enfermedad estable [SD] o progresion de la enfermedad [PD]) durante el tratamiento neoadyuvante por rayos X / mamografia Timepoints:Baseline up to Cycle 4 (assessed at, Baseline and Day 1 of Cycles 1-4 Pre-Surgery) Up to approximately 24 months ; Outcome name:Tumor assessments were made based on the RECIST criteria - version 1.0 The overall response at each cycle up to the last assessment prior to surgery was derived for: i) the primary breast lesion; (ii) across secondary breast lesions, (iii) across all breast lesions (iv) across axillary nodes (v) across supraclavicular nodes and (vi) across all nodes (vii) across all lesions (overall) using the following algorithm: CR: if measurement of 0 is noted at a given cycle as compared to baseline measurement which is >0 at screening or cycle 1 day 1; PR: if measurement is at least a 30% decreased compared to baseline levels . (Reference= baseline size or sum of sizes); SD: if measurement at a given cycle is not sufficient shrinkage to qualify for neither PR nor sufficient increase to qualify for PD | — |
Countries
Australia, Austria, Brazil, Canada, Israel, Italy, Korea South, Mexico, Poland, Russian Federation, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kindgdom
Contacts
Public ContactPATRICIA MATOS
PRODUCTOS ROCHE Q.F.S.A.
Outcome results
None listed