Trial 1B-10-11

An Open-Label, Multi-Center, Randomized Phase II Study Evaluating the Safety and Efficacy of Ramucirumab (IMC-1121B) Drug Product or IMC-18F1 in Combination With Capecitabine or Capecitabine Monotherapy, in Unresectable, Locally Advanced, or Metastatic Breast Cancer Patients Previously Treated With Anthracycline and Taxane Therapy.

Type: Cancer Therapy
Phase: Phase II
Status: Closed to Accrual with Ongoing Follow-up
Treatments: Chemotherapy: Systemic, Immunotherapy
Randomized: Yes
Defintions of terms and FAQ about clinical trials.

Trial Leaders/Researchers: Agustin Garcia, M.D.
Other Trial Staff: Kristy Watkins, R.N., Nancy Perez, R.N., Yvonne Flores, D.M., Anayansi Miloud, D.M.

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You may participate in this study if:

	Requirement
1	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 and/or radiographic evidence of advanced or recurrent disease is available.
2	Measurable or non-measurable disease (RECIST v1.1)
3	Prior anthracycline therapy and has experienced one of the following: [a] Disease progression within 6 months of the last dose of anthracycline therapy in the metastatic setting, or [b] Disease progression after receiving an anthracycline in the adjuvant or neoadjuvant setting, or [c] Discontinuation of anthracycline therapy in any setting due to intolerable toxicity provided there has been evidence of disease progression.
4	Prior taxane therapy and has experienced one of the following: [a] Disease progression within 6 months of the last dose of taxane therapy in the metastatic setting, or [b] Disease progression within 12 months of the last dose of taxane therapy in the adjuvant or neoadjuvant setting, or [c] Discontinuation of taxane therapy in any setting due to intolerable toxicity provided there has been evidence of disease progression.
5	Patient with HER2-positive disease must have progressed on or following trastuzumab
6	Patient with hormone receptor-positive disease must have progressed on or following hormone therapy
7	Must have received < / = 3 prior chemotherapy regimens in any setting
8	Completed any prior radiotherapy = / > 4 weeks prior to randomization
9	Completed any prior hormonal therapy = / > 2 weeks prior to randomization
10	Resolution of all toxicities to < / = Gr 1 from prior chemotherapy, surgery, radiotherapy, or hormonal therapy, except peripheral neuropathy which must have resolved to < / = Grade 2 and except where otherwise noted in the eligibility criteria
11	At least 18 years of age
12	ECOG performance status 0 -1
13	AGC = / > 1.5; platelets = / > 100,000; Hgb = / > 9.5
14	Total bilirubin < / = 1.25 x uln; SGOT and SGPT < / = 3 x uln (< / = 5 x uln if elevation is due to liver mets)
15	Measured or calculated CrCl = / > 60 ml/min
16	INR < / = 1.5; PTT < / = 1.5 x uln if not receiving anti-coagulation therapy. Patients on full-dose anti-coagulation must be on a stable dose of LMW heparin and must have no active bleeding (within 14 days prior to randomization) or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
17	Urinary protein < / = 1+ on dipstick or routine urinalysis; if urine protein = / > 2+, a 24-hr urine collection must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study
18	Agrees to use adequate contraception during the study period and for 12 weeks after the last dose of study medication
19	Amenable to compliance with protocol schedules and testing
20	Signed an approved study-specific informed consent and HIPAA

You may not participate in this study if:

1	Concurrent active malignancy other than adequately treated non-melanomatous skin cancer, curatively treated cervical carcinoma in-situ, or other non-invasive carcinoma or in-situ neoplasm. A patient with previous history of malignancy is eligible, provided there has been a disease-free interval for > 3 years.
2	Known sensitivity to capecitabine, any of its components, or other drugs formulated with polysorbate 80
3	Known sensitivity to 5-FU
4	Known dihydropyrimidine dehydrogenase deficiency
5	Prior capecitabine treatment for advanced breast cancer
6	Prior investigational therapy (including hormone therapy) within 2 weeks prior to randomization
7	Prior bevacizumab within 4 weeks prior to randomization
8	More than 1 prior anti-angiogenic agent for breast cancer
9	Known sensitivity to agents of similar biologic composition as ramucirumab DP or IMC-18F1, or other agents that specifically target VEGF
10	Acute/subacute bowel obstruction or history of chronic diarrhea requiring ongoing medical intervention
11	History of uncontrolled hereditary or acquired bleeding or thrombotic disorders
12	Experienced a Grade = / > 3 bleeding event within 3 months prior to randomization
13	Receiving prophylactic or therapeutic anti-coagulation with warfarin or any other oral anti-coagulant
14	Uncontrolled intercurrent illness, including, but not limited to uncontrolled HTN, symptomatic anemia, symptomatic CHF, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorder in the opinion of the investigator
15	Experienced any arterial thrombotic or thromboembolic events, including, but not limited to MI, TIA, or CVA within 6 months prior to randomization
16	Brain metastases, uncontrolled spinal cord compression, or leptomeningeal disease
17	Ongoing or active infection requiring parenteral antibiotic, anti-fungal, or anti-viral therapy
18	Known HIV infection or AIDS-related illness
19	Prior allogeneic organ or tissue transplantation
20	Undergone major surgery within 4 weeks prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization
21	Serious non-healing wound, ulcer, or bone fracture within 4 weeks prior to randomization
22	Elective or planned major surgery to be performed during the course of the trial
23	Pregnant (confirmed by serum ß-HCG) or lactating women

For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or clinical.trials@med.usc.edu.

To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.