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Cyclophosphamide And Doxorubicin (CA) (4 VS 6 Cycles) Versus Paclitaxel (4 VS 6 Cycles) As Adjuvant Therapy For Breast Cancer in Women With 0-3 Positive Axillary Lymph Nodes:A 2X2 Factorial Phase III

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

RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin, and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether giving cyclophosphamide together with doxorubicin is more effective than giving paclitaxel alone in treating breast cancer. PURPOSE: This randomized phase III trial is studying cyclophosphamide and doxorubicin to see how well they work compared to paclitaxel in treating women with invasive breast cancer.

Date & Status

Active, not recruiting

Who can Participate?


18 and older




- Histologically confirmed invasive carcinoma of the breast with 0-3 positive axillary
lymph nodes

- Meets 1 of the following criteria for node-negative disease:

- Negative sentinel lymph node biopsy

- At least 6 negative axillary lymph nodes removed and determined to be
negative by axillary dissection

- Meets 1 of the following criteria for node-positive disease (1-3 positive
axillary lymph nodes):

- At least 1 positive lymph node by sentinel lymph node biopsy AND at least 6
axillary lymph nodes removed by axillary dissection; of all the nodes
removed from both the sentinel lymph node biopsy and the axillary
dissection, 1-3 must be positive

- At least 6 lymph nodes removed by axillary dissection; 1-3 nodes from the
axillary dissection must be positive

- "High-risk" disease that warrants chemotherapy (ultimately determined by the treating

- Modified radical mastectomy or lumpectomy within the past 84 days required

- Negative tumor margins for invasive cancer and ductal carcinoma in situ (DCIS)

- Lobular carcinoma in situ (LCIS) at the margin allowed

- Multicentric disease allowed provided margins and axillary nodes are negative after

- Bilateral synchronous disease allowed

- Invasive cancer on one side and DCIS or LCIS on the contralateral side is allowed
provided all other eligibility criteria are met

- No locally advanced, inflammatory, or metastatic breast cancer

- No dermal lymphatics involvement, even if there are no clinical signs of inflammatory

- HER2/neu positive, negative, or unknown

- Hormone receptor status:

- Any estrogen and/or progesterone receptor status



- 18 and over


- Female

Menopausal status:

- Premenopausal or postmenopausal

Performance status:

- CTC 0-1

Life expectancy:

- Not specified


- Absolute neutrophil count at least 1,000/mm^3

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


- Bilirubin no greater than 1.5 times upper limit of normal


- Creatinine no greater than 2.0 mg/dL


- No active congestive heart failure

- No myocardial infarction within the past 6 months


- Not pregnant or nursing

- Fertile patients must use effective nonhormonal contraception during and for at least
2 months after study participation

- No other malignancy within the past 5 years except curatively treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix


Biologic therapy:

- No prior trastuzumab (Herceptin^®) for this malignancy


- See Disease Characteristics

- No prior chemotherapy for this malignancy

- No other concurrent chemotherapy

Endocrine therapy:

- No prior hormonal therapy for this malignancy except tamoxifen given for up to 4

- Prior tamoxifen or other selective estrogen receptor modulators (SERMs) for
prevention or other indications (e.g., osteoporosis) allowed

- No concurrent exogenous hormonal therapy (including oral contraceptives,
postmenopausal hormone replacement therapy, or raloxifene) except:

- Steroids for adrenal failure

- Hormonal agents for nondisease-related conditions (e.g., insulin for diabetes or
synthroid for hypothyroidism)

- Intermittent dexamethasone as an antiemetic and premedication for paclitaxel

- No concurrent tamoxifen or other SERMs


- See Disease Characteristics


- No concurrent dexrazoxane

- No concurrent raloxifene

- Concurrent bisphosphonates for osteoporosis allowed

- Concurrent trastuzumab (Herceptin^®) allowed for patients with HER2-positive disease

- Concurrent enrollment on adjuvant bisphosphonate studies allowed

- Concurrent enrollment on adjuvant hormonal studies allowed provided hormonal therapy
does not commence until completion of study chemotherapy

Gender: Female
Steward Physician(s)
  • Lawrence N. Shulman, MD
  • St. Elizabeth's Medical Center - Active, not recruiting
  • Saint Anne's Hospital - Active, not recruiting
  • Norwood Hospital - Active, not recruiting
Trial Interventions
  • AC regimen
  • cyclophosphamide
  • doxorubicin hydrochloride
  • paclitaxel
Physician Researcher

Investigator Name:

  • Lawrence N. Shulman, MD

Other Information

Sponsor: Cancer and Leukemia Group B
Phase: Phase 3
Trial ID: NCT00041119
Volunteers:  Not Accepting Healthy Volunteers

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