Know Cancer

or
forgot password

Correlative Studies of ERBB-2/HER-2/NEU and p53 in CALGB Protocol 9344/INT Protocol 0148: "Doxorubicin Dose Escalation, With or Without Taxol®, as Part of the CA Adjuvant Chemotherapy Regimen For Node Positive Breast Cancer: A Phase III Intergroup Study


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

Correlative Studies of ERBB-2/HER-2/NEU and p53 in CALGB Protocol 9344/INT Protocol 0148: "Doxorubicin Dose Escalation, With or Without Taxol®, as Part of the CA Adjuvant Chemotherapy Regimen For Node Positive Breast Cancer: A Phase III Intergroup Study


OBJECTIVES:

- Correlate erbB-2 (HER-2/neu) amplification and/or overexpression with additional or
less benefit derived from increasing doses of doxorubicin or addition of paclitaxel in
women with node-positive breast cancer, in terms of disease-free and overall survival.

- Correlate abnormalities in p53 (mutations, deletions, protein stabilization) with
additional or less benefit (in terms of disease-free and overall survival) in patients
treated with these regimens.

- Compare methods of assaying for erbB-2 (HER-2/neu) and p53 to determine whether one
method is more predictive of clinical outcome in these patients than the other.

OUTLINE: Formalin-fixed, paraffin-embedded tissue blocks are analyzed for amplification
and/or overexpression of erbB-2 (HER-2/neu) and for mutations or deletions of p53 by
fluorescent in situ hybridization (FISH) and immunohistochemistry.

PROJECTED ACCRUAL: Samples will be collected from a total of 600 patients.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the breast with 1 or more positive lymph
nodes (T1-3, N1, M0)

- Prior enrollment on CLB-9344

- At least 1 block of primary tumor available for sectioning and submission

- Hormone-receptor status

- Any estrogen receptor or progesterone receptor status

PATIENT CHARACTERISTICS:

- Female

- Menopausal status: pre- or post-menopausal

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Correlation of erbB-2 (HER-2/neu) amplification and/or overexpression with more or less benefit from increasing dose of doxorubicin or addition of paclitaxel in women with node-positive breast cancer, in terms of disease-free and overall survival

Safety Issue:

No

Principal Investigator

Minetta C. Liu, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Lombardi Cancer Research Center

Authority:

Unspecified

Study ID:

CDR0000285697

NCT ID:

NCT00899509

Start Date:

October 2000

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • Breast Neoplasms

Name

Location

Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104