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Keck Medical Center of USC
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.
Closed to Accrual with Ongoing Follow-up
Chemotherapy: Systemic, Immunotherapy
Defintions of terms and FAQ about clinical trials.
Agustin Garcia, M.D.
Other Trial Staff:
Kristy Watkins, R.N., Nancy Perez, R.N., Yvonne Flores, D.M., Anayansi Miloud, D.M.
to see study documents.
You may participate in this study if:
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.
Measurable or non-measurable disease (RECIST v1.1)
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.
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.
Patient with HER2-positive disease must have progressed on or following trastuzumab
Patient with hormone receptor-positive disease must have progressed on or following hormone therapy
Must have received < / = 3 prior chemotherapy regimens in any setting
Completed any prior radiotherapy = / > 4 weeks prior to randomization
Completed any prior hormonal therapy = / > 2 weeks prior to randomization
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
At least 18 years of age
ECOG performance status 0 -1
AGC = / > 1.5; platelets = / > 100,000; Hgb = / > 9.5
Total bilirubin < / = 1.25 x uln; SGOT and SGPT < / = 3 x uln (< / = 5 x uln if elevation is due to liver mets)
Measured or calculated CrCl = / > 60 ml/min
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)
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
Agrees to use adequate contraception during the study period and for 12 weeks after the last dose of study medication
Amenable to compliance with protocol schedules and testing
Signed an approved study-specific informed consent and HIPAA
You may not participate in this study if:
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.
Known sensitivity to capecitabine, any of its components, or other drugs formulated with polysorbate 80
Known sensitivity to 5-FU
Known dihydropyrimidine dehydrogenase deficiency
Prior capecitabine treatment for advanced breast cancer
Prior investigational therapy (including hormone therapy) within 2 weeks prior to randomization
Prior bevacizumab within 4 weeks prior to randomization
More than 1 prior anti-angiogenic agent for breast cancer
Known sensitivity to agents of similar biologic composition as ramucirumab DP or IMC-18F1, or other agents that specifically target VEGF
Acute/subacute bowel obstruction or history of chronic diarrhea requiring ongoing medical intervention
History of uncontrolled hereditary or acquired bleeding or thrombotic disorders
Experienced a Grade = / > 3 bleeding event within 3 months prior to randomization
Receiving prophylactic or therapeutic anti-coagulation with warfarin or any other oral anti-coagulant
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
Experienced any arterial thrombotic or thromboembolic events, including, but not limited to MI, TIA, or CVA within 6 months prior to randomization
Brain metastases, uncontrolled spinal cord compression, or leptomeningeal disease
Ongoing or active infection requiring parenteral antibiotic, anti-fungal, or anti-viral therapy
Known HIV infection or AIDS-related illness
Prior allogeneic organ or tissue transplantation
Undergone major surgery within 4 weeks prior to randomization, or subcutaneous venous access device placement within 7 days prior to randomization
Serious non-healing wound, ulcer, or bone fracture within 4 weeks prior to randomization
Elective or planned major surgery to be performed during the course of the trial
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
To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.