Clinical trial NCT00272987 (phase 3, status: terminated)
Conditions: neoplasms, breast
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: lapatinib, paclitaxel, trastuzumab
SMILES: CN(C1=CC2=NN(C)C(C)=C2C=C1)C1=CC=NC(NC2=CC=C(C)C(=C2)S(N)(=O)=O)=N1, [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    enrollment was closed after the open label stage due to poor recruitment rate (randomized stage
    never opened).
  
Eligibility criteria:

        Inclusion criteria:

          -  Histologically confirmed invasive breast cancer with stage IV disease

          -  If trastuzumab was administered in the adjuvant setting, >12 months must have elapsed
             since discontinuation of trastuzumab therapy

          -  If a taxane was administered in the neoadjuvant or adjuvant setting, progression must
             have occurred ≥12 months after completion of this treatment

          -  Had tumors that overexpress ErbB2 defined as either: 3+ by IHC OR c-erbB2 gene
             amplification by FISH OR 0, 1+, 2+ by IHC and c-erbB2 gene amplification by FISH.

          -  Patients must have tumor tissue available for central testing, and must have
             Measurable lesion(s) according to RECIST

          -  Subjects must be females of at least 18 years Non-childbearing potential or
             Childbearing potential but using adequate contraception

          -  Radiotherapy to a limited area other than the sole site of measurable and assessable
             disease is allowed; however, patients must have completed treatment and recovered from
             all acute treatment-related toxicities prior to administration of the first dose of
             study medication

          -  Bisphosphonate therapy for bone metastases is allowed; however, treatment must be
             initiated prior to the first dose of randomized therapy. Prophylactic use of
             bisphosphonates in patients without bone disease is not permitted, except for the
             treatment of osteoporosis

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1

          -  For those patients whose disease is estrogen receptor positive+ and/or progesterone
             receptor + one the following criteria should be met: Patients with visceral disease
             that requires chemotherapy (eg., patients with liver or lung metastases) or Rapidly
             progressing/life threatening disease, as determined by the investigator or Patients
             who received hormonal therapy and are no longer benefiting from this therapy;

          -  Able to swallow and retain oral medication

          -  Cardiac ejection fraction within institutional range of normal

          -  Patient must have adequate organ function

        Exclusion criteria:

          -  Pregnant or lactating females;

          -  Received prior chemotherapy, immunotherapy, biologic therapy, or anti-ErbB1/ErbB2
             therapy for metastatic disease, prior hormonal therapy is permitted but must be
             discontinued a minimum of 7 days prior to randomization;

          -  Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
             resection of the stomach or small bowel. Patients with ulcerative colitis are also
             excluded;

          -  History of other malignancy; however, patients who have been disease-free for five
             years, or patients with a history of completely resected non-melanoma skin cancer or
             successfully treated in situ carcinoma are eligible;

          -  Concurrent disease or condition that would make the patient inappropriate for study
             participation, or any serious medical disorder that would interfere with the patient's
             safety;

          -  Unresolved or unstable, serious toxicity from prior administration of another
             investigational drug and/or of prior cancer treatment;

          -  Peripheral neuropathy of Grade 2 or greater;

          -  Active or uncontrolled infection;

          -  Dementia, altered mental status, or any psychiatric condition that would prohibit the
             understanding or rendering of informed consent;

          -  Known history of uncontrolled or symptomatic angina, arrhythmias, conduction
             abnormalities or congestive heart failure;

          -  Known history or clinical evidence of central nervous system (CNS) metastases or
             leptomeningeal carcinomatosis;

          -  Concurrent cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic
             therapy, hormonal therapy);

          -  Concurrent treatment with an investigational agent or participation in another
             clinical trial;

          -  Concurrent treatment with any medication on the prohibited medications list.

          -  Used an investigational drug within 30 days or 5 half-lives, whichever is longer,
             preceding the first dose of treatment. Hormonal therapy needs to be discontinued at
             least 7 days before the first dose of treatment.

          -  Prior therapy with an ErbB2 inhibitor, other than trastuzumab in the adjuvant setting;

          -  A known immediate or delayed hypersensitivity reaction to drugs chemically related to
             lapatinib or excipients;

          -  A known immediate or delayed hypersensitivity reaction to drugs chemically related to
             paclitaxel or excipients;

          -  A known immediate or delayed hypersensitivity reaction to drugs chemically related to
             trastuzumab or excipients;

          -  Non compliance with any of the screening procedures