A Study for Safety and Effectiveness of IMC-A12 by Itself or Combined With Antiestrogens to Treat Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: IMC-A12 (cixutumumab); tamoxifen; Anastrozole; Letrozole; Exemestane; Fulvestrant
Intervention description: 10 mg/kg I.V.; Daily 20 mg, oral; Daily 1 mg, oral; Daily 2.5 mg, oral; Daily 25 mg, oral; Monthly 250 mg, intramuscularly
Intervention MeSH terms: Tamoxifen; Letrozole; Fulvestrant; Anastrozole; Exemestane; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer; Postmenopausal; Hormones; Antiestrogen

Summary:

      The purpose of this study is to determine whether IMC-A12 offers increased progression-free
      survival (PFS) associated with IMC-A12 monotherapy and IMC-A12 in combination with an
      antiestrogen therapy in patients with hormone receptor positive advanced or metastatic breast
      cancer that have experienced disease progression on antiestrogen therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has histologically or cytologically-confirmed invasive breast cancer,
             which at the time of study entry is either stage III (locally advanced) disease not
             amenable to curative therapy or stage IV disease. Histological confirmation of
             recurrent/metastatic disease is not required if clinical evidence of stage IV disease
             recurrence is available

          -  Tumors are positive for estrogen receptors (ER), progesterone receptors (PgR), or both
             (ie, 10% or more of infiltrating cancer cells exhibit nuclear staining for ER and/or
             PgR; positive biochemical test results are also acceptable)

          -  The patient has received prior antiestrogen therapy:

               1. With at least one antiestrogen agent (with or without ovarian suppression)
                  administered for ≥ 3 months in the adjuvant or metastatic setting; and

               2. Experienced disease progression while on or within 12 months after receiving the
                  last dose of endocrine therapy

          -  The patient is postmenopausal and/or meets at least one of the following criteria:

               1. Age ≥ 18 years with an intact uterus and amenorrhea for ≥ 12 months, with
                  estradiol and/or follicle-stimulating hormone (FSH) values in the postmenopausal
                  range

               2. History of bilateral oophorectomy

               3. History of bilateral salpingo-oophorectomy

               4. History of radiation castration and amenorrheic for ≥ 3 months

          -  The patient has fasting serum glucose < 120 mg/dL or below the ULN

        Exclusion Criteria:

          -  The patient has received more than two regimens of prior chemotherapy in the
             metastatic (or locally advanced and inoperable breast cancer) and adjuvant setting

          -  The patient has poorly controlled diabetes mellitus. Patients with a history of
             diabetes mellitus are allowed to participate, provided that their blood glucose is
             within normal range (fasting glucose at study entry < 120 mg/dL or below ULN) and that
             they are on a stable dietary and/or therapeutic regimen for this condition

          -  The patient is known to be positive for infection with the human immunodeficiency
             virus