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A Multicentre Phase I Study Of Cremophor FreePaclitaxel Nanoparticle In Advanced Breast Cancer

Phase 1
18 Years
65 Years
Open (Enrolling)
Advanced Breast Cancer

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Trial Information

A Multicentre Phase I Study Of Cremophor FreePaclitaxel Nanoparticle In Advanced Breast Cancer

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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).

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary outcomes of the study would be the Pharmacokinetic data at all the four dose levels (220, 260, 310 and 375 mg/m2); Ability to identify a dose higher than 220 mg/m2 that demonstrate better efficacy and manageable toxicity

Outcome Time Frame:

Throughout the study

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

March 2009

Completion Date:

April 2010

Related Keywords:

  • Advanced Breast Cancer
  • Breast Neoplasms