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NCT Number: NCT00590785

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)

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 treated with adjuvant high-dose chemotherapy with doxorubicin plus cyclophosphamide (AC), versus high-dose sequential chemotherapy with doxorubicin followed by cyclophosphamide (A-->C).

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Key information

Conditions

High Risk Breast Cancer Breast Diseases Breast Neoplasms Cyclophosphamide Doxorubicin Neoplasms Neoplasms by Site Positive Nodes Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Doxorubicin

Drug

High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.

Cyclophosphamide

Drug

High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.

G-CSF

Drug

High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.

Other names: Filgrastim

Tamoxifen

Drug

High-dose doxorubicin + cyclophosphamide (AC) x 6 cycles with G-CSF on Days 3 - 12 and followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamoxifen 20 mg daily for 5 years.

Ciprofloxacin

Drug

High-dose sequential doxorubicin x 4 given with G-CSF on Days 3 - 12+ and followed by high-dose cyclophosphamide x 3 (A+C) given with G-CSF and ciprofloxacin on Days 3-12, followed in postmenopausal patients and hormone receptor-positive premenopausal patients by tamxifen 20 mg daily for 5 years.

Primary outcomes

  1. 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.

    Time frame: Conclusion of the study

Secondary outcomes

  1. To obtain tumor tissue for biologic studies. The details of these biologic studies will be described in a companion protocol or protocols to be developed through the Intergroup mechanism.

    Time frame: Conclusion of study

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Collaborators

  • Cancer and Leukemia Group B

Registry information

Important dates

Study start
1996
Primary completion
1997
Study completion
2015
First posted
Jan 11, 2008
Registry last updated
Aug 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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