A phase II trial evaluating the efficacy and safety of epirubicin and cyclophosphamide (EC) followed by docetaxel and gemcitabine (DG) (+ trastuzumab if HER2 positive) as neoadjuvant chemotherapy for women with large operable or locally advanced breast carcinoma

ANZ Breast Cancer Trials Group Ltd.0 个研究点目标入组 81 人开始时间: 2006年5月24日最近更新: 2023年9月26日

研究概览

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•Female patients with a confirmed new diagnosis of unilateral, operable primary breast cancer, (clinically and/or on ultrasound), T2 (=3cm only), T3-4, N0-1, M0, diagnosed by core biopsy. The disease must be considered operable at first presentation. HER2 expression must be determined using either immunohistochemistry or FISH.• Patients with HER2 negative breast cancer must have a measured left ventricular ejection fraction of = 50% with MUGA or echocardiogram. Patients with HER2 positive breast cancer must have a measured left ventricular ejection fraction of = 55% with MUGA or echocardiogram.• No prior chemotherapy or hormonal therapy for breast cancer or other invasive cancer.• Adequate bone marrow, hepatic and renal function• ECOG performance status of 0, 1 or 2.• Women of child-bearing potential must have a negative pregnancy test and agree to use an accepted and effective method of non-hormonal contraception (barrier method of birth control; abstinence).• An ability to understand and the willingness to sign a written informed consent document.• Patients must be accessible for follow-up.• Patients must be informed of and agree to data and tissue material transfer and handling, in accordance with national data protection guidelines.

•Prior chemotherapy or hormonal therapy for breast cancer or other invasive cancer.• Patients with inoperable, or inflammatory or metastatic breast cancer.• History of an active malignancy other than in situ carcinoma of the cervix, or non-melanomatous skin cancers in the last five years prior to registration to the study.• Patients may not be receiving any other investigational agents.• Congestive heart failure (New York Heart Association (NYHA) Class III-IV) or history of congestive failure, unstable angina pectoris, myocardial infarction in the last 6 months, poorly controlled hypertension (systolic >180 mmHg or diastolic > 100 mmHg), clinically significant valvular disease, or high risk uncontrolled arrhythmias. • History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.• Patients with dyspnoea at rest due to malignant or other disease or who require supportive oxygen therapy. • Patients who are pregnant or lactating at the time of registration to the trial. • Any active uncontrolled infection.• Any other medical condition which the investigator’s opinion makes the subject unsuitable for study participation.• Patients with a history of hypersensitivity reaction to products containing Polysorbate 80 (Tween).

发起方

ANZ Breast Cancer Trials Group Ltd.