Trastuzuamb in HER-2 negative early breast cancer as added treatment after surgery for patients presenting CTC (Circulating Tumor Cells)

Recruitment & Eligibility

Status: ot Recruiting

Sex: Female

Target Recruitment: 1317

Inclusion Criteria

? Female gender
? Age = 18 years
? Written informed consent must be given according to ICH/GCP, and national/local regulations
? Availability of peripheral blood draw for CTC blood test
? Tumor block or minimum 10 unstained slides of 10 µm of primary tumor must be available prior to registration for centralized HER2 testing
? ER status available
? Adequately excised non-metastatic and non-relapsed operable primary invasive HER2-negative adeno-carcinoma of the breast that is all of the following*:
? Histological Grade > 1 at time of surgery and primary tumor size > 1 cm
? the patient should have completed either
? adjuvant chemotherapy for node-positive disease (pN =1, macrometastasis only) or
? neoadjuvant chemotherapy; in this case residual invasive disease in breast or lymph nodes is required (no complete pathological response)
? Completion of (neo-) adjuvant chemotherapy and no further adjuvant chemotherapy treatment planned. Prior chemotherapy with doxorubicin restricted to a total dose of 360 mg/m2 or with epirubicin restricted to a total dose of 720 mg/m2 is allowed
? No prior use of anti-HER2 therapy for any reason or other prior use of biological agent or immunotherapy for BC
? No prior and or concomitant use of bisphosphonate therapy for any reason
? No prior mediastinal irradiation except internal mammary node irradiation for the present BC
? Concomitant adjuvant hormonal therapy or radiotherapy (if applicable) is allowed upon physician’s choice
? The interval between definitive surgery (neoadjuvant population) or end of adjuvant chemotherapy (adjuvant population) and registration must be at least 3 weeks but no more than 12 weeks
? No evidence of unresolved or unstable toxicity from prior surgery, adjuvant chemotherapy or radiotherapy
? No history of prior (ipsilateral and/or contralateral) invasive breast carcinoma or ductal carcinoma in situ, except for the BC proposed in this study. Bilateral breast cancer is acceptable if both tumors are HER2- negative and have been diagnosed within 2 years from registration
? No history of any malignant neoplasms in the past 5 years except for curatively treated basal and squamous cell carcinoma of the skin
? No prior autologous or allogeneic stem cell transplantation
? No history of serious cardiac illness or medical conditions, including but not confined to:
? History of documented congestive heart failure
? High risk uncontrolled arrhythmias
? Angina pectoris requiring anti-anginal medication
? Clinically significant valvular heart disease
? Evidence of transmural infarction on ECG
? Poorly controlled hypertension (e.g. systolic > 180 mm Hg or diastolic > 100 mm Hg)
? No history of other concurrent serious diseases that may interfere with planned treatment, including severe pulmonary conditions
? Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration
? No concurrent participation in another trial
* Imaging work up is not mandatory to enter the trial. If there are signs/symptoms suggesting the presence of local relapse or distant metastasis, an appropriate work up should be performed according to the treating physician standard practice. If a patient is confirmed to have local relapse or distant metastasis she is no longer eligible for the trial.
Are the trial subjects under 18?

Exclusion Criteria

Please see inclusion criteria

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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