Clinical Trial Details
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NCT01597414 : Elderly Metastatic Breast Cancer: Pertuzumab-Herceptin vs Pertuzumab-Herceptin-Metronomic Chemotherapy, Followed by T-DM1
PhasePhase 2
AgesMin: 60 Years Max: N/A
Inclusion Criteria:

- Patients with histologically proven HER-2 positive

- Newly diagnosed or recurrent (after surgery) stage IV disease (TNM/AJCC v.7).

- Patients must have measurable (RECIST v. 1.1) or evaluable disease

- Performance status (PS) 0-3 (WHO)

- Age ? 70 years of age, or ? 60 years old with required number of dependencies

- Life expectancy of more than 12 weeks

- Previous adjuvant chemotherapy/anti HER-2 therapy after surgery is allowed, given
that the time interval from end of previous treatment to initiation of treatment for
metastatic disease is ? 6 months.

- Up to one line of anti-HER therapy (trastuzumab or lapatinib) is allowed in
combination with hormone therapy for hormone sensitive metastatic breast cancer.

- Adequate organ function

- Before patient randomization, written informed consent must be given according to
ICH/GCP, and national/local regulations.

Exclusion Criteria:

- No brain metastases that are untreated, symptomatic, or require steroids to control
symptoms; or any radiation, surgery, or other therapy to control symptoms from brain
metastases within 2 months prior to the first study treatment.

- No prior chemotherapy for metastatic disease is allowed

- No prior treatment with pertuzumab is allowed

- No history of exposure to the following cumulative doses of anthracyclines:

- Doxorubicin or liposomal doxorubicin > 360 mg/m2

- Epirubicin > 720 mg/m2

- Mitoxantrone > 120 mg/m2

- Idarubicin > 90 mg/m2

- If another anthracycline or more than 1 anthracycline has been used, then the
cumulative dose must not exceed the equivalent of 360 mg/m2 of doxorubicin.

- No history of palliative radiotherapy within 14 days of randomization

- No history of other malignancy within the last 5 years, except for carcinoma in situ
of the cervix or basal cell or spinocellular carcinoma of the skin

- No current uncontrolled hypertension (persistent systolic > 180 mmHg and/or diastolic
> 100 mmHg)

- No LVEF below 50%

- No history of significant cardiac disease defined as:

- Symptomatic CHF (NYHA classes II-IV)

- High-risk uncontrolled arrhythmias

- History of myocardial infarction within 6 months prior to randomization

- Clinically significant valvular heart disease

- No angina pectoris requiring anti-angina treatment

- No peripheral neuropathy of Grade ? 3 per NCI CTCAE version 4.0.

- No current severe, uncontrolled systemic disease (e.g., clinically significant
cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; or
bone fractures, known infection with HIV, active hepatitis B and/or hepatitis C

- No major surgical procedure or significant traumatic injury within 28 days prior to
randomization or anticipation of the need for major surgery during the course of
study treatment

- No history of receiving any investigational treatment within 28 days of randomization

- No history of intolerance (including Grade 3-4 infusion reaction) to trastuzumab

- No unwillingness or inability to comply with the requirements of the protocol as
assessed by the investigator

- 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 in the
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