Combination Chemotherapy and Trastuzumab in Treating Women With Stage I, Stage II, or Stage III HER2-Positive Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, HER2-positive breast cancer
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
Sites / Locations
- Ospedale Santa CroceRecruiting
- Ospedale Civile di IvreaRecruiting
- Azienda Ospedaliera - Universitaria di ModenaRecruiting
- Piacenza HospitalRecruiting
- Azienda Sanitaria Ospedale San Giovanni Battista Molinette di TorinoRecruiting
- Ospedal San AndreaRecruiting