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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?

This randomized phase III trial studies cyclophosphamide and doxorubicin hydrochloride compared with paclitaxel as adjuvant therapy in treating breast cancer in women with 0-3 positive axillary lymph nodes. Giving additional cancer treatment after surgery may help to lower the risk that the cancer will come back (adjuvant therapy). Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether the standard adjuvant therapy of cyclophosphamide and doxorubicin hydrochloride is more effective than paclitaxel in treating women with breast cancer

Date & Status

Active, not recruiting

Who can Participate?


18 and older



Eligibility Criteria:

- Patients must have histologically confirmed invasive carcinoma of the female breast,
with 0-3 positive axillary lymph nodes

- Patients must have 0-3 positive axillary lymph nodes to be eligible for this study;
patients with node-negative breast cancer should have sufficiently "high risk"
disease to warrant chemotherapy; as general guidelines, node-negative patients with
tumors of >= 1 cm or estrogen or progesterone receptor negative tumors of any size
may be eligible; ultimately though, the definition of "high risk" may be determined
by the treating physician, and if the treating physician feels the patient warrants
chemotherapy, the patient is eligible; for patients with 1-3 positive axillary nodes,
the patient is eligible regardless of primary breast tumor characteristics, if in the
opinion of the treating physician, chemotherapy is deemed potentially beneficial to
the patient

- If the patient has had a negative sentinel node biopsy, then no further axillary
dissection is required, and the patient is determined to be node-negative; if an
axillary dissection, without a sentinel node biopsy, is performed to determine nodal
status, at least six axillary lymph nodes must be removed and analyzed and negative
for the patient to be considered node-negative; axillary nodes with single cells or
tumor clusters =< 0.2 mm by either hematoxylin and eosin stain (H&E) or
immunohistochemistry (IHC), will be considered node-negative; lymph nodes positive
for polymerase chain reaction (PCR) with tumor cells/clusters =< 0.2 mm will be
considered node-negative; any axillary lymph node with tumor clusters > 0.2 mm will
be considered positive

- If the patient has a sentinel node biopsy and one of the sentinel nodes is positive,
as defined by tumor clusters > 0.2 mm, an axillary dissection must be performed; a
total of at least 6 axillary lymph nodes, including sentinel nodes plus the
subsequent dissection, must be removed for the patient to be eligible; of all the
lymph nodes removed from both the sentinel node procedure and the axillary
dissection, 1-3 must be positive for the patient to be eligible as a node-positive
patient; if an axillary dissection is done without a sentinel node procedure, at
least 6 lymph nodes must be removed and a 1-3 nodes must be positive for the patient
to be considered node-positive and eligible for this study

- Determination of involvement of axillary nodes with metastatic cancer will follow the
revised tumor-node-metastasis (TNM) staging system: axillary nodes with single cells
with tumor clusters =< 0.2 mm, by either H&E or immunohistochemistry (IHC), will be
considered negative axillary node; lymph nodes positive for PCR with tumor
cells/clusters < 0.2 mm will be considered negative axillary node; any axillary lymph
node with clusters > 0.2 mm will be considered to be positive

- Patients with estrogen-receptor and/or progesterone receptor negative, positive, or
unknown tumors are eligible; estrogen-receptor (ER) and progesterone receptor (PgR)
assays should be performed by immunohistochemical methods according to the local
institution's standard protocol

- Patients with human epidermal growth factor receptor 2 (HER2) positive, negative or
unknown disease are eligible for this trial; patients whose tumors are HER2 positive
by either immunohistochemistry 3+ staining or demonstrate gene amplification by
fluorescence in situ hybridization (FISH) may receive trastuzumab

- There must be negative tumor margins for invasive cancer and ductal carcinoma in situ
(DCIS) in the case of mastectomy or lumpectomy; lobular carcinoma in situ (LCIS) is
acceptable at the margin

- Patients with multi-centric breast cancer are eligible as long as all known disease
is resected with negative margins, and have 0-3 positive axillary lymph nodes

- Patients must be registered within 84 days of the last breast surgery; patients must
have undergone either modified radical mastectomy or lumpectomy; for patients
undergoing sentinel node sampling or axillary dissection a simple mastectomy is
acceptable; lumpectomy patients must receive radiation therapy; for patients treated
with radiation therapy prior to chemotherapy, the patients should be registered on
this study after the conclusion of radiation, with chemotherapy administration
beginning within 7 days of registration

* All primary breast and axillary node surgery must be completed prior to enrollment
on study

- No previous trastuzumab, chemotherapy or hormonal therapy for this malignancy, except
for tamoxifen therapy

- No previous anthracycline chemotherapy for any disease

- Patients with locally advanced breast cancer, inflammatory breast cancer or
metastatic breast cancer are not eligible; patients with involvement of dermal
lymphatics on pathology are not eligible, even if there are no clinical signs of
inflammatory cancer

- Patients with bilateral, synchronous invasive breast cancer are eligible as long as
both primary tumors; if a patient has an invasive cancer on one side that meets the
eligibility criteria, and DCIS or LCIS on the contralateral side, the patient is
eligible; DCIS or LCIS should be managed according to institutional guidelines

- Patients must be disease free from prior malignancies for > 5 years, except for
curatively treated basal cell or squamous cell carcinoma of the skin or
carcinoma-in-situ of the cervix; patients with a history of invasive breast cancer,
or DCIS are eligible if they have been disease free for > 5 years; patients with a
history of LCIS are eligible regardless of the interval from diagnosis

- Common Toxicity Criteria (CTC) performance status 0-1

- Women must not be pregnant or nursing

- Concomitant exogenous hormone therapy, including oral contraceptives, post-menopausal
hormone replacement therapy, and raloxifene must be stopped before patients can be

- Patients may have received up to 4 weeks of tamoxifen therapy for this malignancy and
still be eligible for this study; patients who received tamoxifen or another
selective estrogen receptor modulator (SERM) for prevention or for other indicators
(e.g. osteoporosis) are eligible; tamoxifen therapy or other SERMs must be
discontinued before the patient is enrolled on this study

* The use of bisphosphonates for the treatment of osteoporosis is permitted; the use
of raloxifene is not permitted are enrollment on this study

- Patients must have adequate organ function including no active congestive heart
failure, and no myocardial infarction < 6 months from time of registration

- Absolute neutrophil count (ANC) >= 1,000/mm^3

- Platelet count >= 100,00/mm^3

- Creatinine =< 2.0 mg/dl

- Bilirubin =< 1.5 x upper limits of institutional normal

- Patients may be enrolled on adjuvant bisphosphonate studies; patients may be enrolled
concurrently or sequentially on 40101 and bisphosphonate trials

- Patients may be enrolled on adjuvant hormonal studies approved by CALGB or Cancer
Trials Support Unit (CTSU), such as the Suppression of Ovarian Function Trial (SOFT)
and Tamoxifen and Exemestane Trial (TEXT) trials

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: Alliance for Clinical Trials in Oncology
Phase: Phase 3
Trial ID: NCT00041119
Volunteers:  Not Accepting Healthy Volunteers

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