None listed
Conditions
Interventions
Intervention1: Docetaxel: 75 mg/m2
Intervention2: Cisplatin OR Carboplatin: 70 mg/m2
Control Intervention1: NIL: Not Applicabale
Sponsors
Indian Cooperative Oncology network (ICON)
Panacea
Eligibility
Inclusion criteria
Inclusion criteria: ? Signed written informed consent to be obtained ? Women of at least 18 yrs of age ? Women of child bearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of investigational product in such a manner that the risk of pregnancy is minimized ? WOCBP must have a negative serum or urine pregnancy test within 72 hrs before the first dose of investigational product ? Karnofsky performance status (KPS) of 80 to 100 ? Accessible for treatment and follow up ? Previously untreated female patients with bi-dimensionally palpable and measurable primary inoperable breast carcinoma stage T3 and above, diagnosed by open/core biopsy. Diagnostic criteria are: 1. larger than 5 cms (T3) 2. involving skin/chest wall (T4) 3. metastasis to ipsilateral Ax LNs causing them to be matted (N2) 4. metastasis to ipsilateral internal mammary LNs (N3) 5. Localized M1 [metastasis to ipsilateral supraclavicular LNs - AJCC] ? Patients had to have adequate organ function defined as a leukocyte count of at least 4,000/mm3 ? A platelet count of at least 100,000/mm3 ? A hemoglobin level of at least 9.5 g/dl (5.9 mmol/L) ? Total bilirubin &#8804; 1.5 times the upper limit of normal(ULN) ? Aspartate aminotransferase and alanine aminotransferase levels <100 IU/ml ? A serum creatinine level <1.2 mg/dl (106 mmol/L), and a creatinine clearance of at least 60 ml/min.
Exclusion criteria
Exclusion criteria: ? WOCBP who are unwilling or unable to use an acceptable method of contraception ? Women who are pregnant (including positive pregnancy test at enrollment or prior to study drug administration) or breast feeding. ? Patients who have received prior treatment (including hormonal therapy, chemotherapy, radiotherapy or biological therapy) for LABC. Concomitant use of above therapy will not be allowed. ? Evidence of Inflammatory breast cancer ? Evidence of baseline sensory or motor neuropathy ? Known human immune deficiency viral (HIV) infection. ? Clinically significant history of cardiovascular disease (history of unstable angina, congestive heart failure, uncontrolled hypertension, myocardial infarction or valvular heart disease). ? Current participation in another drug trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To study the clinical, radiological and pathologic tumour response rate for Locally Advanced Breast Cancer when administered Neo-Adjuvant Docetaxel plus PlatinumTimepoint: After every cycle of chemotherapy | — |
Secondary
| Measure | Time frame |
|---|---|
| To study the toxicity and safety of Neo-Adjuvant Docetaxel plus Platinum in LABCTimepoint: After every cycle of chemotherapy | — |
Countries
India
Contacts
Public ContactDr Khurshid Mistry
Outcome results
None listed