Clinical trial NCT00003782 (phase 3, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: cyclophosphamide, docetaxel, doxorubicin
SMILES: ClCCN(CCCl)P1(=O)NCCCO1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, COC1=CC=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed invasive adenocarcinoma of the breast

               -  Confined to the breast and ipsilateral axilla on clinical exam

                    -  Stage I, II, or IIIA (cT1-3, N0-1, M0)

          -  At least one axillary lymph node with evidence of tumor on histologic exam

               -  Sentinel node biopsy allowed if followed by axillary dissection

               -  No suspicious palpable nodes in the contralateral axilla or palpable
                  supraclavicular or infraclavicular nodes, unless proven on biopsy to not be
                  involved with tumor

          -  No bilateral malignancy or mass in the opposite breast, unless mass is histologically
             proven to be benign

          -  Must have undergone either a prior total mastectomy and axillary dissection (modified
             radical mastectomy) OR

          -  Prior lumpectomy and axillary dissection

               -  Patients must receive radiotherapy after randomization (not before) AND after
                  chemotherapy

               -  Margins must be clear

               -  No ipsilateral lymph nodes that are fixed to one another or to other structures
                  (N2 disease) and/or any positive nonaxillary lymph nodes (intramammary nodes are
                  considered axillary nodes)

               -  No histologically evident invasive tumor or ductal carcinoma in situ

               -  No diffuse tumors by mammography that would not be surgically amenable to
                  lumpectomy

               -  No other dominant mass in the ipsilateral breast remnant unless one of the
                  following is true:

                    -  Histologically benign

                    -  Surgically removed with clear margins if malignant

          -  No ulceration, erythema, infiltration of the skin or underlying chest wall (complete
             fixation), peau d'orange, or skin edema of any magnitude

               -  Tethering or dimpling of the skin or nipple inversion allowed

          -  No metastatic disease

               -  Skeletal pain allowed if bone scan negative for metastases

          -  Hormone receptor status:

               -  Estrogen and progesterone status determined

        PATIENT CHARACTERISTICS:

        Age:

          -  greater than or equal to 18 years

        Sex:

          -  Female

        Menopausal status:

          -  Not specified

        Performance status:

          -  Not specified

        Life expectancy:

          -  At least 10 years, excluding diagnosis of cancer

        Hematopoietic:

          -  Absolute neutrophil count at least 1,500/mm^3 (may be less, if in the opinion of the
             investigator, this represents an ethnic or racial variation)

          -  Platelet count at least 100,000/mm^3* NOTE: *If platelet count is above the upper
             limit of normal (ULN), significant underlying hematologic disorders must be excluded

        Hepatic:

          -  Bilirubin no greater than ULN

          -  Alkaline phosphatase less than 2.5 times ULN*

          -  SGOT less than 1.5 times ULN*

          -  No nonmalignant systemic hepatic disease that would preclude study participation NOTE:
             *Alkaline phosphatase and SGOT cannot both be greater than ULN

        Renal:

          -  Creatinine no greater than normal

          -  No nonmalignant systemic renal disease that would preclude study participation

        Cardiovascular:

          -  No nonmalignant systemic cardiovascular disease that would preclude study
             participation

          -  LVEF at least lower limit of normal (LLN) by MUGA or echocardiogram

          -  No active cardiac disease that would preclude use of doxorubicin or docetaxel,
             including the following:

               -  Any prior myocardial infarction

               -  Angina pectoris requiring anti-anginal medication

               -  History of congestive heart failure

               -  Cardiac arrhythmia requiring medication

               -  Severe conduction abnormality

               -  Valvular disease with documented cardiac function compromise

               -  Cardiomegaly on chest x-ray or ventricular hypertrophy on EKG, unless LVEF at
                  least LLN

               -  Poorly controlled hypertension (diastolic greater than 100 mm/Hg)

               -  Hypertension well controlled by medication allowed

        Other:

          -  No grade 2 or greater peripheral neuropathy

          -  No other prior malignancy within the past 5 years except:

               -  Effectively treated squamous cell or basal cell skin cancer

               -  Surgically treated carcinoma in situ of the cervix

               -  Segmentally resected lobular carcinoma in situ of the ipsilateral or
                  contralateral breast

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective barrier contraception

          -  No nonmalignant systemic disease that would preclude study participation

          -  No diabetes with morning fasting blood glucose of 200 mg/dL or greater

          -  No psychiatric or addictive disorders that would preclude informed consent

          -  No contraindication to corticosteroids that would preclude study participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy:

          -  No prior immunotherapy for breast cancer

        Chemotherapy:

          -  No prior chemotherapy for breast cancer

          -  No prior anthracyclines or taxanes

          -  No other concurrent investigational chemotherapy

        Endocrine therapy:

          -  No prior hormonal therapy for breast cancer

          -  No concurrent hormonal birth control methods or other hormonal therapy

          -  No concurrent raloxifene, including for osteoporosis

          -  Concurrent low-dose topical estrogen in the form of conjugated estrogen ring or
             conjugated estrogen vaginal cream (dose no more than 0.3 mg or 1/8 of an applicator
             applied vaginally 3 times a week) allowed

        Radiotherapy:

          -  See Disease Characteristics

          -  No prior radiotherapy for this malignancy

        Surgery:

          -  See Disease Characteristics

          -  No more than 84 days since prior surgery for breast cancer (e.g., lumpectomy,
             mastectomy, sentinel node biopsy, axillary dissection, or re-excision of lumpectomy
             margins)

        Other:

          -  No prior systemic therapy for this malignancy

          -  No concurrent medications that alter cardiac conduction (e.g., digitalis, beta
             blockers, or calcium-channel blockers) for cardiac arrhythmia, angina, or congestive
             heart failure (allowed if administered for other reasons [e.g., hypertension])

          -  Concurrent bisphosphonates allowed