Clinical trial NCT00629278 (phase 3, status: unknown status)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: aromatase inhibition therapy, cyclophosphamide, docetaxel, doxorubicin hydrochloride, epirubicin hydrochloride, fluorouracil, paclitaxel, releasing hormone agonist therapy, tamoxifen citrate
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, 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, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, COC1=CC(NCC2=C(C)C3=C(C=C2)N=C(N)N=C3N)=CC(OC)=C1OC
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of infiltrating primary breast cancer

               -  Stage I-IIIA disease

               -  Resected tumor with free margins (i.e., no neoplastic cells on the resected
                  margin)

                    -  Must have node-negative sentinel node or complete axillary clearance

                         -  Axillary clearance required for micrometastasis (between 0.2 and 2 mm)
                            in the sentinel node but not for isolated tumor cells

                    -  Treatment is scheduled to begin within 10 weeks from the date of surgery

                         -  Date of the last surgery will be taken into account for patients
                            undergoing re-excision of positive margins or axillary lymph node
                            dissection after positive sentinel node biopsy

          -  Node positivity or node negativity AND ≥ 1 of the following:

               -  T > 2 cm

               -  Grade 3

               -  Presence of lymphovascular invasion

               -  Ki 67 > 20%

               -  Age 35 years

               -  Hormone receptor negativity (<10%)

          -  HER2-positive tumor (3+ by IHC or FISH+ according to the American Society of Clinical
             Oncology guidelines [i.e., > 2.2; in case of polysomy, with ≥ 6 gene copies])

          -  Estrogen receptor-positive and/or progesterone receptor-positive disease

        PATIENT CHARACTERISTICS:

          -  Female

          -  Pre- or postmenopausal status

               -  Postmenopausal status defined by ≥ 1 of the following:

                    -  At least 60 years of age

                    -  Less than 60 years of age and amenorrheic for ≥ 12 months prior to day 1

                    -  Less than 60 years of age and amenorrheic for < 12 months prior to day 1
                       with luteinizing hormone and follicle-stimulating hormone values within
                       postmenopausal range OR without a uterus

                    -  Prior bilateral oophorectomy

                    -  Prior radiation castration with amenorrhea for ≥ 6 months

          -  ECOG performance status 0-1

          -  Suitable for adjuvant chemotherapy

          -  WBC > 3,000/mcL

          -  ANC > 1,500/mcL

          -  Platelet count >100,000/mcL

          -  Total bilirubin normal

          -  AST and ALT 2.5 times upper limit of normal

          -  Creatinine normal

          -  Cardiac ejection fraction normal as measured by ECHO or MUGA scan

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for ≥ 3 months after
             completion of study therapy

          -  No contraindication to anthracycline, cyclophosphamide, fluorouracil, paclitaxel, or
             trastuzumab (Herceptin®) treatment

          -  No uncontrolled intercurrent illness including, but not limited to, the following:

               -  Ongoing or active infection

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Cardiac arrhythmia

               -  Psychiatric illness/social situations that would limit compliance with study
                  requirements

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  See Patient Characteristics

          -  No prior chemotherapy, endocrine therapy, or radiotherapy

          -  No other concurrent investigational agents