University of Southern California
USC Norris Comprehensive Cancer Center
If you are a patient, please contact Keck Medical Center of USC at 800-USC-CARE.

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.

Staff may log in to see study documents.


You may participate in this study if:
 Requirement
1Histologically 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.
2Measurable or non-measurable disease (RECIST v1.1)
3Prior 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.
4Prior 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.
5Patient with HER2-positive disease must have progressed on or following trastuzumab
6Patient with hormone receptor-positive disease must have progressed on or following hormone therapy
7Must have received < / = 3 prior chemotherapy regimens in any setting
8Completed any prior radiotherapy = / > 4 weeks prior to randomization
9Completed any prior hormonal therapy = / > 2 weeks prior to randomization
10Resolution 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
11At least 18 years of age
12ECOG performance status 0 -1
13AGC = / > 1.5; platelets = / > 100,000; Hgb = / > 9.5
14Total bilirubin < / = 1.25 x uln; SGOT and SGPT < / = 3 x uln (< / = 5 x uln if elevation is due to liver mets)
15Measured or calculated CrCl = / > 60 ml/min
16INR < / = 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)
17Urinary 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
18Agrees to use adequate contraception during the study period and for 12 weeks after the last dose of study medication
19Amenable to compliance with protocol schedules and testing
20Signed an approved study-specific informed consent and HIPAA


You may not participate in this study if:
1Concurrent 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.
2Known sensitivity to capecitabine, any of its components, or other drugs formulated with polysorbate 80
3Known sensitivity to 5-FU
4Known dihydropyrimidine dehydrogenase deficiency
5Prior capecitabine treatment for advanced breast cancer
6Prior investigational therapy (including hormone therapy) within 2 weeks prior to randomization
7Prior bevacizumab within 4 weeks prior to randomization
8More than 1 prior anti-angiogenic agent for breast cancer
9Known sensitivity to agents of similar biologic composition as ramucirumab DP or IMC-18F1, or other agents that specifically target VEGF
10Acute/subacute bowel obstruction or history of chronic diarrhea requiring ongoing medical intervention
11History of uncontrolled hereditary or acquired bleeding or thrombotic disorders
12Experienced a Grade = / > 3 bleeding event within 3 months prior to randomization
13Receiving prophylactic or therapeutic anti-coagulation with warfarin or any other oral anti-coagulant
14Uncontrolled 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
15Experienced any arterial thrombotic or thromboembolic events, including, but not limited to MI, TIA, or CVA within 6 months prior to randomization
16Brain metastases, uncontrolled spinal cord compression, or leptomeningeal disease
17Ongoing or active infection requiring parenteral antibiotic, anti-fungal, or anti-viral therapy
18Known HIV infection or AIDS-related illness
19Prior allogeneic organ or tissue transplantation
20Undergone major surgery within 4 weeks prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization
21Serious non-healing wound, ulcer, or bone fracture within 4 weeks prior to randomization
22Elective or planned major surgery to be performed during the course of the trial
23Pregnant (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.