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Phase III Trial of Continuous Schedule AC + G vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or

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Trial Conditions
  • Breast Cancer
What is the purpose of this trial?

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating resected breast cancer. PURPOSE: This randomized phase III trial is comparing 2 different regimens of combination chemotherapy to see how well they work in treating patients who have undergone surgery for stage I, stage II, or stage III breast cancer.

Date & Status

Active, not recruiting

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

DISEASE CHARACTERISTICS:

- Histologically confirmed stage I-III invasive breast cancer

- Operable disease

- Stage I, II, IIIA, and IIIC (T1-3, N3a only)

- No T4 tumors

- High-risk disease, defined by 1 of the following:

- Tumor ≥ 2 cm in greatest diameter (includes both invasive and intraductal
component)

- Patients with nodal status of N0+ (i.e., no cluster of tumor cells in any
node greater than 0.2 mm) are considered to be node negative and must have
a primary tumor ≥ 2 cm in size or have a tumor ≥ 1 cm with high risk
features

- Patients who are node negative on the basis of a sentinel node procedure
and fewer than 6 axillary nodes are removed are eligible OR at least 6
axillary or intramammary nodes must be negative

- Tumor ≥ 1 cm in diameter and meeting 1 of the following criteria:

- ER-negative and PgR-negative

- ER-positive or PgR-positive with a Genomic Health Recurrence Score of ≥ 26

- One or more axillary or intramammary nodes are involved by metastatic breast
cancer

- If one or more nodes is involved, a minimum of 6 axillary or intramammary
nodes must have been examined histologically

- Patients with N0(I+) disease will be considered node negative

- HER2/neu-positive tumors (3+ by immunohistochemical staining or amplified by
fluorescence in-situ hybridization) allowed

- Bilateral synchronous breast cancer diagnosed within 1 month of each other allowed
provided the higher TNM stage primary tumor meets the eligibility criteria

- Prior modified radical mastectomy OR local excision of all tumors with axillary lymph
node dissection or sentinel node resection required

- No more than 84 days since prior surgery for the primary tumor and/or axilla

- Final resection margins for the primary tumor must be histologically negative
for invasive cancer and ductal carcinoma in situ

- Resection margins positive for lobular carcinoma in situ are allowed

- Hormone receptor status:

- Estrogen receptor status known

- Progesterone receptor status known

PATIENT CHARACTERISTICS:

Age

- 18 and over

Sex

- Male or female

Menopausal status

- Not specified

Performance status

- Zubrod 0-2

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count at least 1,200/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than upper limit of normal (ULN)

- Alkaline phosphatase no greater than 2 times ULN

- SGOT or SGPT no greater than 2 times ULN

Renal

- Creatinine no greater than ULN

Cardiovascular

- No congestive heart failure

- No active angina pectoris

- LVEF greater than or equal to the lower limit of normal* by MUGA or echocardiogram
NOTE: Patients age 60 and over OR with a history of hypertension

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer, in situ cervical carcinoma, or lobular carcinoma in situ
of the breast

- Prior invasive breast cancer or ductal carcinoma in situ allowed if disease-free
for 5 years

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- No prior cytotoxic chemotherapy for this breast cancer

- No prior chemotherapy with an anthracycline, anthracenedione, or taxane

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy for this malignancy

- At least 2 weeks since prior radiotherapy for ductal carcinoma in situ

Surgery

- See Disease Characteristics

Gender: Both
Steward Physician(s)
  • George Thomas Budd, MD
  • Halle C Moore, MD
Facilities
  • St. Elizabeth's Medical Center - Active, not recruiting
Trial Interventions
Biological
  • pegfilgrastim
Drug
  • AC regimen
  • cyclophosphamide
  • doxorubicin hydrochloride
  • paclitaxel
Physician Researcher

Investigator Name:

  • George Thomas Budd, MD
  • Halle C Moore, MD

Other Information

Sponsor: Southwest Oncology Group
Phase: Phase 3
Trial ID: NCT00070564
Volunteers:  Not Accepting Healthy Volunteers

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