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Phase II Clinical Trial of Neoadjuvant Weekly Doxorubicin, Polyglutamate Paclitaxel, Capecitabine and Metronomic Chemotherapy in Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Phase II Clinical Trial of Neoadjuvant Weekly Doxorubicin, Polyglutamate Paclitaxel, Capecitabine and Metronomic Chemotherapy in Breast Cancer


Inclusion Criteria:



- SWOG performance status of 0-2

- Projected life expectancy of at least 3 months

- Female age 18 years and over

- Provision of informed consent prior to any study-related procedures.

- Hormone receptor positive or negative tumor

- Her 2 neu negative tumor

- Negative pregnancy test for women of childbearing potential

- Patients must agree to use some form of contraception while on this study at
initiation and for the duration of participation in the study. Sexually active males
must also use a reliable and appropriate method of contraception. Post-menopausal
women must be amenorrheic for at least 12 months to be considered of non-childbearing
potential.

- ANC > 1500, Platelet count > 100,000, Hemoglobin > 9.0

- Serum creatinine < 1.5 mg/dl

- Hepatic function: Patients must have adequate liver functions: AST or ALT < 2.5 X
upper limit of normal (ULN), alkaline phosphatase < 2.5 X upper limit of normal.
Serum Bilirubin < 1.5 mg

- Peripheral neuropathy grade 0-1

- No other concomitant therapy directed at the cancer is allowed.

Exclusion Criteria:

- Serum bilirubin > 1.5 the upper limit of reference range (ULRR)

- Serum creatinine >1.5

- Prior therapy for this tumor.

- Clinical Congestive Heart Failure

- Women who are currently pregnant or breast feeding.

- Receipt of any investigational agents within 30 days prior to commencing study
treatment

- Prior radiation must not have included ≥ 30% of major bone marrow containing areas
(pelvis, lumbar spine)

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, lobular carcinoma
in-situ of the breast (LCIS), or any other cancer from which the patient has been
disease-free for 5 years. Patients with prior invasive breast cancer or ductal
carcinoma in-situ (DCIS) are eligible if they have been disease free for 5 years and
did not receive prior treatment with doxorubicin and/or a taxane.

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:

Response

Outcome Time Frame:

At surgical resection on about week 30

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

1B-08-7

NCT ID:

NCT01227408

Start Date:

February 2009

Completion Date:

Related Keywords:

  • Breast Cancer
  • Patients with confirmed breast cancer for neoadjuvant chemotherapy
  • Breast Neoplasms

Name

Location

USC/Norris Comprehensive Cancer CenterLos Angeles, California  90033-0800