EUCTR2011-006342-32-SEActive, not recruitingPhase 1
Pertuzumab + trastuzumab (PH) versus PH plus metronomic chemotherapy (PHM) in the elderly HER2+ metastatic breast cancer population who may continue on T-DM1 alone following disease progression while on PH / PHM: an open-label multicenter randomized phase II selection trial of the EORTC Elderly Task Force and Breast Cancer Group - NA
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- EORTC
- Enrollment
- 80
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •- Patients with histologically proven HER-2 positive (IHC 3+ or or HER-2 gene amplification by in situ hybridization [FISH, SISH or CISH]) invasive breast cancer, based on the results of local laboratories of the participating centers. All histologies are eligible.
- •- Newly diagnosed or recurrent (after surgery) stage IV disease (TNM/AJCC v.7).
- •- No current symptomatic brain metastases or if previously present, must have been treated at least two months before randomization. CT or MRI scan of the brain is mandatory (within 4 weeks prior to randomization) if there is clinical suspicion of brain metastases.
- •- 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 as described below :
- •- 65 – 69 in combination with functional restriction defined as limitation in at least 2 of 8 iADL or 1 of 6 ADL or Charlson comorbidity score > 2
- •- 60 – 64 in combination with functional restrictions defined as limitation in at least 3 of 8 iADL or 2 of 6 ADL or Charlson comorbidity score > 3
- •- 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.
- •- 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 prior to 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) (with or without medication).
- •- No LVEF below 50%
- •- No history of significant cardiac disease defined as:
- •- Symptomatic CHF (NYHA classes II-IV,)
- •High-risk uncontrolled arrhythmias, i.e. atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or highergrade AV-block (2nd
- •degree AV-block Type 2 [Mobitz 2] or 3rd degree AV-block)
- •- 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.
- •- Adequate organ function, evidenced by the following laboratory results within 3 weeks prior to randomization: (patients with a buffer range from the normal values of +/- 5% for hematology and +/-10% for biochemistry [with the EXCEPTION of GFR] are acceptable)
- •- Absolute neutrophil count > 1500 cells/mm3
- •- Platelet count > 100,000 cells/mm3
- •- Hemoglobin > 8.5 g/dL
- •- Total bilirubin = 1.5 ULN
- •- SGOT (AST), SGPT (ALT), and ALP= 2.5× ULN (for ALP limit applies in the absence of bone metastases)
- •- GFR = 30 ml/min a
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.
- •-Prior chemotherapy for metastatic disease.
- •-Prior treatment with pertuzumab.
- •-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.
- •-History of palliative radiotherapy within 14 days of /prior to randomization.
- •-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.
- •-Current uncontrolled hypertension (persistent systolic > 180 mmHg and/or diastolic > 100 mmHg) (with or without medication).
- •-LVEF below 50%.
- •-History of significant cardiac disease defined as:
- •Symptomatic CHF (NYHA classes II-IV, see Appendix C)
- •High-risk uncontrolled arrhythmias, i.e. atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia (ventricular tachycardia) or higher-grade AV-block (second degree AV-block Type 2 [Mobitz 2] or third degree AV-block)
- •History of myocardial infarction within 6 months prior to randomization
- •Clinically significant valvular heart disease
- •angina pectoris requiring anti-angina treatment
- •-Peripheral neuropathy of Grade =3 per NCI CTCAE version 4.0.
- •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 virus)
- •-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.
- •-History of receiving any investigational treatment within 28 days of randomization.
- •-History of intolerance (including Grade 3-4 infusion reaction) to trastuzumab.
- •-Unwillingness or inability to comply with the requirements of the protocol as assessed by the investigator.
Investigators
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