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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00590785
First Posted: January 11, 2008
Last Update Posted: August 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cancer and Leukemia Group B
Information provided by (Responsible Party):
National Cancer Institute (NCI)
  Purpose
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).

Condition Intervention Phase
High Risk Breast Cancer Positive Nodes Cyclophosphamide Doxorubicin Drug: Doxorubicin Drug: Cyclophosphamide Drug: G-CSF Drug: tamoxifen Drug: ciprofloxacin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Estimated Enrollment: 60
Study Start Date: August 13, 1996
Study Completion Date: January 13, 2015
Primary Completion Date: June 10, 1997 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Doxorubicin
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.
Drug: Cyclophosphamide
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.
Drug: G-CSF
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 Name: Filgrastim
Drug: tamoxifen
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.
Experimental: 2 Drug: Doxorubicin
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.
Drug: Cyclophosphamide
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.
Drug: G-CSF
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 Name: Filgrastim
Drug: ciprofloxacin
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.

  Eligibility

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590785


Locations
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
National Cancer Institute (NCI)
Cancer and Leukemia Group B
Investigators
Principal Investigator: Clifford Hudis, MD Memorial Sloan Kettering Cancer Center
  More Information

Additional Information:
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00590785     History of Changes
Other Study ID Numbers: 96-041
INT 0137
CALGB 9394
First Submitted: December 26, 2007
First Posted: January 11, 2008
Last Update Posted: August 25, 2017
Last Verified: August 2017

Keywords provided by National Cancer Institute (NCI):
High Risk
Breast Cancer
Positive Nodes
Cyclophosphamide
Doxorubicin
96-041

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Liposomal doxorubicin
Doxorubicin
Tamoxifen
Ciprofloxacin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents