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 or
? neoadjuvant chemotherapy; in this case residual invasive disease in
breast or lymph nodes is required (no complete pathological response)
? 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. A patient with confirmed local relapse or distant metastasis will no longer be eligible for the trial.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of

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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