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A Pilot Study of Neoadjuvant Biweekly Doxorubicin and Cyclophosphamide (AC) With GMCSF Followed by Weekly Carboplatin/Paclitaxel With Plus and Minus Traztuzumab (TC ± H) in the Treatment of Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Inflammatory Breast Cancer, Locally Advanced Breast Cancer

Thank you

Trial Information

A Pilot Study of Neoadjuvant Biweekly Doxorubicin and Cyclophosphamide (AC) With GMCSF Followed by Weekly Carboplatin/Paclitaxel With Plus and Minus Traztuzumab (TC ± H) in the Treatment of Breast Cancer


Inclusion Criteria:



- Patients must be women with a histologically confirmed diagnosis of locally advanced
or inflammatory (see Section 10.1a) breast carcinoma. Histologic confirmation shall
be by either core needle biopsy or incisional biopsy. Punch biopsy is allowed if
invasive breast cancer is documented.

- Patients must meet one of the criteria defined below (indicate one):

1. Selected Stage IIB (T3, N0, M0) or IIIA (T3, N1-2, M0) disease judged primarily
unresectable by an experienced breast surgeon; or otherwise deemed appropriate
candidates for neoadjuvant treatment.

2. Stage IIIB (T4, Any N, M0) or (Any T, N3, M0) disease.

- Patient who had prior Adriamycin will receive TC±H

- Physical examination, chest x-ray and any x-rays or scans needed for tumor assessment
must be performed within 90 days prior to registration.

- Patients with the clinical diagnosis of congestive heart failure or angina pectoris
are NOT eligible. Patients with hypertension or age > 60 years must have a MUGA or
echocardiogram scan performed within 90 days prior to registration (indicate NA if no
MUGA required) and LVEF% must be greater than the institutional lower limit of
normal.

- Patients must have a serum creatinine and bilirubin ≤ the institutional upper limit
of normal, and an SGOT or SGPT ≤ 2x the institutional upper limit of normal. These
tests must have been performed within 90 days prior to registration.

- Patients must have an ANC of ≥ 1,500/μl and a platelet count of ≥ 100,000/μl. These
tests must have been performed within 90 days prior to registration.

- Patients must have a performance status of 0-2 by Zubrod criteria

- Pregnant or nursing women may not participate due to the possibility of fetal harm or
of harm to nursing infants from this treatment regimen. Women of reproductive
potential may not participate unless they have agreed to use an effective
contraceptive method. A urine pregnancy test is required for women of childbearing
potential.

- All patients must be informed of the investigational nature of this study and must
sign and give written informed consent in accordance with institutional and federal
guidelines.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To measure the clinic response rates

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Rita Mehta, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Chao Family Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

UCI 03-70

NCT ID:

NCT00256243

Start Date:

April 2004

Completion Date:

December 2008

Related Keywords:

  • Inflammatory Breast Cancer
  • Locally Advanced Breast Cancer
  • Breast Neoplasms
  • Inflammatory Breast Neoplasms

Name

Location

Chao Family Comprehensive Cancer CenterOrange, California  92868