An exploratory phase II, single arm, multicenter study to evaluate the efficacy and safety of the combination of pertuzumab and Herceptin® (trastuzumab) in patients with HER2-positive metastatic breast cancer.

Recruitment & Eligibility

Status: ot Recruiting

Sex: Not specified

Target Recruitment: 95

Inclusion Criteria

1. Histologically confirmed breast cancer.
2. HER2-positive tumors. HER2 status must be re-confirmed in a central lab before study entry.
3. Availability of a FFPE tumor tissue sample from primary tumor for eligibility (HER2-status) testing and biomarker assessment
4. Patients with metastatic breast cancer, who have progressed on Herceptin-based therapy as last treatment for metastatic disease.
5. Patients with = 3 chemotherapy regimens prior to study entry.
6. The last dose of Herceptin must have been given = 9 weeks prior to study day 1.
7. At least one measurable lesion according to RECIST. A measurable lesion in a previously irradiated area has to reveal clear signs of progression (increase in size of = 50% or new lesions)
8. At least 4 weeks since prior radiotherapy, with full recovery.
9. At least 4 weeks since major surgery, with full recovery.
10. LVEF of = 55 % or local parameter for = LLN by echocardiography or MUGA.
11. Performance status ECOG = 2.
12. Age = 18 years
13. Signed informed consent.
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 subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Prior treatment with any targeted therapy other than Herceptin, such as cetuximab, bevacizumab, gefitinib or with anticancer vaccine.
2. Prior exposure to the following cumulative doses of anthracyclines: doxorubicin or liposomal doxorubicine > 360 mg/m2, epirubicin > 720 mg/m2, mitoxantrone > 120 mg/m2, idarubicin > 90 mg/m2
3. Known asymptomatic decreases in LVEF to below 50% absolute value during Herceptin treatment.
4. Patients with known history of any cardiac adverse event which according to the criteria of the investigator was related to Herceptin therapy.
5. History of congestive heart failure (any NYHA grading), unstable angina, evidence of transmural infarction on ECG, poorly controlled hypertension (systolic > 180 mm Hg and/or diastolic > 100 mm Hg), or hemodynamically significant valvular disease.
6. Other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma
7. Absolute Neutrophil Count (ANC) < 1.5 x 10(9)/L, Platelet count < 100 x 10(9)/L or Hb < 10 g/dL.
8. Impaired liver function: serum [total] bilirubin > 1.5 x ULN, AST, ALT > 2.5 x ULN, (> 5 x ULN in patients with liver metastases).
9. Serum creatinine > 2 x ULN
10. History or clinical evidence of brain metastases.
11. Severe uncontrolled systemic disease (e.g. hypertension, clinically significant cardiovascular, pulmonary, metabolic, wound-healing, ulcer, or bone fracture).
12. Patients with severe dyspnea at rest requiring supplementary oxygen therapy due to complications of advanced malignancy.
13. Positive serum pregnancy test in women of childbearing potential.
14. Patients with reproductive potential not willing to use effective method of contraception.
15. Pregnant or lactating women.
16. Patients with known infection with HIV, HBV, HCV.
17 Known hypersensitivity to Herceptin, murine proteins, or to any of its excipients.
18. Treatment with any investigational drug within 28 days prior to the start of the study.
19. Patients assessed by the investigators to be unable or unwilling to comply with the requirements of the protocol.

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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