1303GCC: Trastuzmab & Pertuzumab With Hormonal Therapy or Chemotherapy in Women Aged 60 and Over.

Exclusion Criteria

• •1. Stage III or IV cancer, other than breast cancer, in ≤5 years prior to registration.
• •2. Actively being treated for other malignancy.
• •3. New York Heart Association Class III or IV cardiovascular disease.
• •4. History of coronary heart failure (CHF)
• •5. Current use of drugs known to prolong the QTc interval including Class Ia and III antiarrhythmics or history of congenital long QTc syndrome.
• •6. Evidence of active brain metastasis including leptomeningeal involvement.
• •7. Major surgery, chemotherapy, hormonal or immunologic therapy ≤3 weeks prior to registration.
• •8. Radiotherapy ≤3 weeks prior to registration, except if to a non-target lesion only.
• •9. Prior treatment with Pertuzumab, Eribulin, Fulvestrant or Anastrozole.
• •10. Uncontrolled illness.
• •11. Co-morbid systemic illnesses or other severe concurrent disease. See section 3.2.11.
• •12. Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered.
• •13. Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive.
• •14. International normalized ratio (INR), activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) \>1.5 × ULN (unless on anticoagulation medication)
• •15. Receipt of intravenous (IV) antibiotics for infection within 7 days prior to enrollment into the study.
• •16. Current chronic daily treatment with corticosteroids. See section 3.2.16 of this protocol.
• •17. Known hypersensitivity to any of the study treatments or to excipients of recombinant human or humanized antibodies.
• •18. History of receiving any investigational treatment within 28 days prior to enrollment into the study.
• •19. Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.