Adjuvant Stage 2-3A Breast Cancer With Positive Lymph Nodes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-07-31

Study Completion Date

2012-09-30

Brief Summary

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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with filgrastim and radiation therapy works in treating patients with stage II or stage IIIA breast cancer.

Detailed Description

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OBJECTIVES:

* Determine the feasibility of administering adjuvant paclitaxel, dose-intensive cyclophosphamide, and filgrastim (G-CSF), followed by doxorubicin and then radiotherapy in patients with stage II or IIIA breast cancer involving \> 4 lymph nodes.
* Determine the incidence of febrile neutropenia in these patients during the first course of therapy.
* Compare the incidence of febrile neutropenia and duration of neutropenia in patients treated with this regimen with that seen in patients treated on protocol CWRU-4194.
* Determine the disease-free and overall survival of patients treated with this regimen.
* Evaluate the quality of life of these patients.
* Correlate HER-2/neu overexpression with disease-free and overall survival in these patients.

OUTLINE: Patients receive paclitaxel IV continuously and cyclophosphamide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until day 14 or until blood counts recover. Treatment repeats every 21 days for 3 courses. Patients then receive doxorubicin IV on day 1 and G-CSF SC on days 2-11 every 21 days for 4 courses.

Patients with hormone receptor positive disease also receive oral tamoxifen daily for 5 years beginning at the completion of chemotherapy.

Beginning 3-6 weeks after the completion of chemotherapy, patients receive radiotherapy 5 days a week for 6-7 weeks.

Quality of life is assessed days 1 and 4 of the first course of chemotherapy, day 1 of the second course, the last day of the final course, and at 6 months after the completion of treatment.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.

Conditions

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Breast Cancer

Keywords

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stage II breast cancer stage IIIA breast cancer male breast cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A: Combination Chemotherapy

Paclitaxel IV continuously over 72 hours on days 1-3 and cyclophosphamide IV on days 1-3. Filgrastim subcutaneously (SC) beginning on day 5 and continuing until blood counts recover or pegfilgrastim SC on day 5. Treatment repeats every 21 days for 3 courses. Then doxorubicin hydrochloride IV on day 1 and filgrastim SC beginning on day 2 and continuing until blood counts recover or pegfilgrastim SC on day 2. Treatment repeats every 21 days for 4 courses. Patients with hormone-receptor positive tumors receive oral tamoxifen citrate or oral anastrozole daily for 5 years following chemotherapy. Beginning 3-6 weeks after completion of chemotherapy, patients undergo radiation therapy 5 days a week for 6-7 weeks.

Group Type EXPERIMENTAL

filgrastim

Intervention Type BIOLOGICAL

Neupogen (G-CSF) given at a dose of 10 ugm/kg subcutaneously starting on day 5 and continuing until ANC \> 10,000/uL x1 day after the nadir cycles 1-3.

cyclophosphamide

Intervention Type DRUG

cyclophosphamide 700 mg/m2 daily for 3 day every 3 weeks cycles 1-3

doxorubicin hydrochloride

Intervention Type DRUG

Patients then receive doxorubicin IV on day 1.

paclitaxel

Intervention Type DRUG

Paclitaxel 160 mg/m2 given over 72 hours by continuous infusion days 1-3

tamoxifen citrate

Intervention Type DRUG

tamoxifen at a dose of 20 mg daily for 5 years after chemotherapy is completed

adjuvant therapy

Intervention Type PROCEDURE

Patients receive paclitaxel IV continuously and cyclophosphamide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until day 14 or until blood counts recover. Treatment repeats every 21 days for 3 courses. Patients then receive doxorubicin IV on day 1 and G-CSF SC on days 2-11 every 21 days for 4 courses.

radiation therapy

Intervention Type RADIATION

Beginning 3-6 weeks after the completion of chemotherapy, patients receive radiotherapy 5 days a week for 6-7 weeks.

Interventions

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filgrastim

Neupogen (G-CSF) given at a dose of 10 ugm/kg subcutaneously starting on day 5 and continuing until ANC \> 10,000/uL x1 day after the nadir cycles 1-3.

Intervention Type BIOLOGICAL

cyclophosphamide

cyclophosphamide 700 mg/m2 daily for 3 day every 3 weeks cycles 1-3

Intervention Type DRUG

doxorubicin hydrochloride

Patients then receive doxorubicin IV on day 1.

Intervention Type DRUG

paclitaxel

Paclitaxel 160 mg/m2 given over 72 hours by continuous infusion days 1-3

Intervention Type DRUG

tamoxifen citrate

tamoxifen at a dose of 20 mg daily for 5 years after chemotherapy is completed

Intervention Type DRUG

adjuvant therapy

Patients receive paclitaxel IV continuously and cyclophosphamide IV over 2 hours on days 1-3. Patients also receive filgrastim (G-CSF) subcutaneously (SC) beginning on day 5 and continuing until day 14 or until blood counts recover. Treatment repeats every 21 days for 3 courses. Patients then receive doxorubicin IV on day 1 and G-CSF SC on days 2-11 every 21 days for 4 courses.

Intervention Type PROCEDURE

radiation therapy

Beginning 3-6 weeks after the completion of chemotherapy, patients receive radiotherapy 5 days a week for 6-7 weeks.

Intervention Type RADIATION

Other Intervention Names

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G-CSF, Neupogen® recominant-methionyl human granulocyte-colony stimulating factor granulocyte colony stimulating factor r-methHuG-CSF Cytoxan® CTX CPM Neosar® Taxol®

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically confirmed stage II or IIIA breast cancer

* At least 5 axillary lymph nodes
* No T4 or N3 disease
* No distant metastases by CT scan of the chest, abdomen, and pelvis; bone scan; and bone marrow evaluation
* No more than 8 weeks since prior lumpectomy or mastectomy with axillary node dissection

* Negative surgical margins
* Hormone receptor status:

* Hormone receptor status known

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Sex:

* Male or female

Menopausal status:

* Not specified

Performance status:

* ECOG 0-1

Life expectancy:

* Not specified

Hematopoietic:

* WBC at least 3,500/mm\^3
* Granulocyte count at least 1,500/mm\^3
* Platelet count greater than 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* SGOT no greater than 1.5 times ULN
* Alkaline phosphatase no greater than 1.5 times ULN

Renal:

* Creatinine no greater than 1.5 mg/dL

Cardiovascular:

* No poorly controlled ischemic heart disease or congestive heart failure

Pulmonary:

* No severe chronic obstructive or restrictive pulmonary disease

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No severe diabetes mellitus
* No other severe concurrent medical or psychiatric illness that would preclude study participation
* No other malignancy within past 5 years except curatively treated ductal carcinoma in situ, lobular carcinoma in situ, or breast cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior radiotherapy

Surgery:

* See Disease Characteristics

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brenda W. Cooper, MD

Role: STUDY_CHAIR

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Locations

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Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Site Status

UH-LUICC

Mentor, Ohio, United States

Site Status

UH-Chagrin Highlands

Orange, Ohio, United States

Site Status

Countries

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United States