Health Condition 1: null- The target population for this study is male or female patients with HER2-positive advanced breast cancer (locally recurrent, unresectable, or metastatic).
Conditions
Interventions
Intervention1: PERTUZUMAB,
TRASTUZUMAB,
DOCETAXEL: Pertuzumab, trastuzumab, and docetaxel chemotherapy will be administered in line with the PI. Docetaxel treatment will be given at least for 6 treatm
thereafter decision for continuation of docetaxel treatment will be based on investigatorâ??s discretion
Each treatment cycle is 3 weeks (21 days) in duration. The initial dose (Cycle 1, Day 1) of pe
Sponsors
Roche Products India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female patients age >=18 years 2. Signed, written informed consent (approved by the relevant Institutional Review Board [IRB]/Ethics Committee[EC]), prior to any study procedure 3. Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection; patients with measurable and/or non-measurable disease are eligible 4. Known and documented HER2-positive (defined as either immunohistochemistry [IHC] 3+ or in situ hybridization [ISH] positive) as assessed on primary tumor and/or metastatic site if primary tumor not available (ISH positivity is defined as a ratio of 2.0 or greater for the number of HER2 gene copies to the number of signals for CEP17, or for single probe tests,a HER2 gene count greater than 4) as determined in a local laboratory that is experienced/certified in HER2-expression testing using an accurate and validated assay 5. Known and documented LVEF of at least 50% 6. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 7. A negative serum β-HCG test for women of childbearing potential (premenopausal, or months of amenorrhea post-menopause, and women who have not undergone surgical sterilization [i.e., absence of ovaries and/or uterus]) within 7 days prior to the first dose of study treatment with the result available prior to first dosing 8. For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly-effective non-hormonal form of contraception or two effective forms of non-hormonal contraception by the patient and/or partner. Contraception use must continue for the duration of study treatment and for at least 7 months after the last dose of study treatment. Male patients whose partners are pregnant should use condoms for the duration of the pregnancy. (for women of childbearing potential: agreement to remain abstinent (only if it is in line with the preferred and usual lifestyle) or use single or combined non-hormonal contraceptive methods that result in a failure rate of least 7 months after the last dose of study drug) 9. Adequate organ function, as determined by the following laboratory results, within 3 days prior to study treatment: · Absolute neutrophil count >1,500 cells/mm3 · Platelet count >100,000 cells/mm3 · Hemoglobin >9 g/dL. (patients may receive transfused red blood cells to obtain this level) · Albumin >2.5 g/dL · Total bilirubin documented Gilbertâ??s syndrome · Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) >2.5 Ã? ULN ( >5 Ã? ULN for patients with liver metastases) · Alkaline phosphatase (ALP) >2.5 Ã? ULN ( >5 Ã? ULN in patients with liver metastases or >10 Ã? ULN for patients with bone metastases) · Serum creatinine >2.0 mg/dL or 177 mmol/L · International normalized ratio (INR), activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) <1.5 Ã? ULN (unless on therapeutic anti-coagulation)
Exclusion criteria
Exclusion criteria: 1. Previous systemic non-hormonal anticancer therapy for the metastatic or locally recurrent disease 2. Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except trastuzumab and/or lapatinib in the adjuvant or neo-adjuvant setting 3. Disease progression while receiving or within 12 months of completion of trastuzumab and/or lapatinib treatment in the adjuvant or neo-adjuvant setting 4. History of persistent Grade 2 or higher (NCI-CTCAE, Version 4.03) hematologic toxicity resulting from previous adjuvant or neo-adjuvant therapy 5. Current, known peripheral neuropathy of Grade 3 or greater (NCI-CTCAE, Version 4.03) 6. History of other malignancy within the last 5 years prior to 1st study drug administration (dosing), except for carcinoma in situ of the cervix or basal cell carcinoma 7. Serious uncontrolled concomitant disease that would contraindicate the use of any drug used in this study or that would put the patient at high risk for treatment-related complications 8. Uncontrolled hypertension (systolic >150 mmHg and/or diastolic >100 mmHg) or clinically significant (i.e. active and/or requiring medication) cardiovascular disease, including but not limited to cerebrovascular accident (CVA)/stroke or myocardial infarction within 6 months prior to first study medication, unstable angina, CHF of New York Heart Association (NYHA) grade II or higher, or serious cardiac arrhythmia requiring medication, or other cardiovascular problem that is uncontrolled or is currently controlled with medication 9. Current known infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) 10. Dyspnea at rest due to complications of advanced malignancy, or other disease requiring continuous oxygen therapy 11. Major surgical procedure or significant traumatic injury within 14 days prior to 1st study drug administration (dosing) or anticipation of need for major surgery during the course of study treatment 12. Known hypersensitivity to any of the study medications or to excipients of recombinant human or humanized antibodies 13. History of receiving any investigational treatment within 28 days prior to first study drug administration (dosing) and/or concurrent participation in any interventional clinical trial 14. Pregnant or lactating women 15. CNS Metastasis 16. LVEF decline to below 50 percentage
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures for this study are on safety evaluationTimepoint: â?¢ Incidence and severity of AEs and serious adverse events (SAEs) by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03 â?¢ Incidence of congestive heart failure (CHF) and/or significant decline in LVEF â?¢ LVEF over the course of the study â?¢ Laboratory results abnormalities â?¢ Incidence of AEs leading to discontinuation, modification, or interruption of study medication â?¢ Incidence and cause of death due to AEs | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures for this study are on efficacy evaluationTimepoint: â?¢ Overall response rate (assessed by RECISTv1.1) â?¢ Progression-free survival (assessed by RECISTv1.1) â?¢ Overall Survival Patients who were alive at the time of the analysis will be censored at the date of the last follow-up assessment (two years from last patient enrolled in the study) | — |
Countries
India
Contacts
Public ContactJitendra Soni
Roche Products (India) Pvt. Ltd.
Outcome results
None listed