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Phase II Study of CT-2103 in Patients With Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Metastatic Breast Cancer

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Trial Information

Phase II Study of CT-2103 in Patients With Metastatic Breast Cancer


- Patients will be given CT-2103 intravenously every 3 weeks. One week after the first
dose of CT-2103 a physical exam, blood work and assessment of any side effects will be
performed.

- Prior to each injection of CT-2103, a physical exam, blood work and assessment of any
side effects will be performed (every 3 weeks).

- Every 6 weeks the patient's cancer will be re-evaluated with either a CT scan or MRI to
determine whether the treatment is working.

- Additional blood work will be performed once per week after the first two doses of
CT-2103.

- The participation in this study will last at least 2 cycles (6 weeks), however patients
may remain on the study as long as there is no disease progression, and they are able
to tolerate the study drug without severe side effects.


Inclusion Criteria:



- Histologically or cytologically confirmed diagnosis of invasive breast cancer, Stage
IV disease

- Age greater than 18 years

- At least one measurable target lesion as defined by RECIST that has not been
previously treated with local therapy

- HER2-negative breast cancer

- Up to one prior chemotherapy for advanced or metastatic disease

- ECOG performance status 0-1

- Life expectancy > 12 weeks

- Adequate liver and bone marrow function: AST < 2.5 x ULN; Bilirubin < 1.5 x ULN; ANC
> 1,500/ul; platelet count > 100,000/ul; normal PT and PTT

- At least 2 weeks since prior radiation and recovered from treatment-related toxicity

Exclusion Criteria:

- Prior taxanes for treatment of metastatic disease

- Pregnant of breast-feeding women

- HER2-positive breast cancer

- More than 1 prior chemotherapy regimen for metastatic disease

- Untreated brain metastases

- Concurrent radiotherapy or investigational drug

- Prior bone marrow or stem cell transplant

- History of other malignancy within the last 5 years, not including curatively-treated
carcinoma in situ of the cervix or non-melanoma skin cancer

- Uncontrolled infection

- Active bleeding, or history of bleeding requiring transfusion

- Active cardiac disease

- Serious medical or psychiatric illness

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To evaluate the response to CT02103 as first or second-line treatment in patients with metastatic breast cancer.

Principal Investigator

Lawrence N. Shulman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

04-299

NCT ID:

NCT00148707

Start Date:

October 2004

Completion Date:

September 2007

Related Keywords:

  • Breast Cancer
  • Metastatic Breast Cancer
  • Metastatic Breast Cancer
  • HER2-negative Breast Cancer
  • CT-2103
  • Xyotax
  • Breast Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115