A Multicentre Phase I Study Of Cremophor FreePaclitaxel Nanoparticle In Advanced Breast Cancer
- Female patients with histopathologically /cytologically confirmed advanced breast
cancer, refractory / recurrent* to previous anthracycline treatment as adjuvant or
first line therapy for metastasis.
- Patients with ER/PR -ve or ER/PR receptor status unknown (defined as no
histopathological evidence for confirmation of ER/PR status)
- Patients must be of 18-65 years of age (inclusive of both)
- Patients with ECOG performance status between 0 - 2
- Patients with at least one measurable lesion as per RECIST
- Patients with ER/PR positive status. Patients who demonstrate HER2 over expression
will be excluded. Alternatively, the patients enrolled should have previously
received trastuzumab. HER2 over expression should be demonstrated by IHC 3+, IHC 2+
or with FISH/CIS.
- Patients with known history of hypersensitivity to paclitaxel or any other taxane or
compounds chemically / biologically related to paclitaxel or excipients.
- Patients requiring any concurrent chemotherapy, hormonal therapy immunotherapy,
therapy with biologicals or radiotherapy for the disease. (Patients requiring local
radiotherapy for non- target bone lesion will be included).
- Patients with known CNS lesions (brain metastasis or carcinomatous meningitis).