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Phase III Comparison of Adjuvant Chemotherapy W/High-Dose Cyclophosphamide Plus Doxorubicin (AC) vs Sequential Doxorubicin Fol by Cyclophosphamide (A-C) in High Risk Breast Cancer Patients With 0-3 Positive Nodes (Intergroup, CALGB 9394)


Phase 3
N/A
N/A
Open (Enrolling)
Female
High Risk, Breast Cancer, Positive Nodes, Cyclophosphamide, Doxorubicin

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Trial Information

Phase III Comparison of Adjuvant Chemotherapy W/High-Dose Cyclophosphamide Plus Doxorubicin (AC) vs Sequential Doxorubicin Fol by Cyclophosphamide (A-C) in High Risk Breast Cancer Patients With 0-3 Positive Nodes (Intergroup, CALGB 9394)

Inclusion Criteria


- Patients must have been diagnosed with primary invasive adenocarcinoma of the breast.
Those patients with the special types including pure tubular, mucinous and papillary
carcinoma are not eligible. Patients must not have sarcoma, lymphoma, or apocrine,
adenocystic or squamous cell cancer of the breast. Patients must not have recurrent
invasive breast cancer. Metaplastic carcinomas are eligible as a variant form of
adenocarcinoma.

- Patients must have undergone an axillary dissection, and at least 6 nodes must have
een removed and examined. Nodal involvement by tumor must be negative or must not
xceed three positive nodes.

- disease must be considered sufficiently high-risk by the investigator to justify the
use of chemotherapy. To be eligible, disease must satisfy one of the following
requirements:

1. Tumor is both ER negative and PgR negative and greater than 1.0 cm in greatest
diameter. Negative is defined as c 10 fmollmg cytosol protein if measured in
these units; othennrise negative is defined according to institutional
standards.

2. Tumor that is greater than 2.0 cm in greatest diameter irrespective of hormone
receptor status (including unknown).

3. Tumor involves one to three axillary lymph nodes.

- Breast cancer was not locally advanced at diagnosis. This is left to investigator
judgement, but generally should exclude patients with fixed tumors, fixed nodes, peau
d'orange skin changes, skin ulcerations or inflammatory changes (T4 disease).

- Patient Is currently free of breast cancer (no evidence of disease). This is also
left to investigator judgement, but generally should include no evidence of distant
disease on chest x-ray or mgmmogram of the opposite breast prior to registration,
within 3 months prior to surgery; and no gross or microscopically positive surgical
margins noted in the final surgery or pathology reports. Patients with synchronous
bilateral breast cancer may be considered, provided both breasts are treated with
curative intent and that eligibility is based on the side with the most adverse
prognostic features.

- Registration must be within 84 days of mastectomy, or within 84 days of axillary
dissection if the patient's most extensive breast surgery was a breast sparing
procedure. Patients not having mastectomy or breast sparing surgery are ineligible.
Patients must not have had prior chemotherapy for this breast cancer. Patients must
not have had systemic therapy of any type for a previous breast cancer.

- Patients must not have had external beam radiotherapy for this breast cancer prior to
registration. Brachytherapy (interstitial radiation therapy) at the time of breast
sparing procedure is acceptable and would not render the patient Ineligible. (If
external beam radiotherapy is planned to be given with brachytherapy, it must be
delayed until after chemotherapy is complete.) Patients whose most extensive breast
surgery was a breast sparing procedure must be planning to receive radiotherapy after
chemotherapy is complete.

- Patients must have adequate hematologic, hepatic, renal and cardiac function for high
dose chemotherapy and adequate health for long-term follow-up. This must Include
normal WBC (2 4,0001pl). neutrophll count (2 1,50O/pl), platelet count (2
Institutional lower limit of normal), and LVEF (left ventricular ejection fraction by
institutional criteria); bilirubin within 1.5 times institutional upper limit of
normal; creatinine within 1.5 times institutional upper limit of normal; and no
serious disease other than breast cancer.

- Pregnant or nursing women may not participate. Men are ineligible. Women of
childbearing potential must be planning to use effective contraception.

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

- At the time of registration, the date of institutional review board approval for this
study must be provided to the Statistical Center.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To compare disease-free survival (DFS), overall survival (s), and toxicity of high-isk primary breast cancer patients with negative axillary lymph nodes or with one to three positive nodes.

Outcome Time Frame:

Conclusion of the study

Safety Issue:

Yes

Principal Investigator

Clifford Hudis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

96-041

NCT ID:

NCT00590785

Start Date:

August 1996

Completion Date:

December 2013

Related Keywords:

  • High Risk
  • Breast Cancer
  • Positive Nodes
  • Cyclophosphamide
  • Doxorubicin
  • High Risk
  • Breast Cancer
  • Positive Nodes
  • Cyclophosphamide
  • Doxorubicin
  • 96-041
  • Breast Neoplasms

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021