Patient case: 70-year-old male with Lung cancer. Genetic variant: ERBB2 Amplification. Other conditions: Arthritis.

Clinical trial: Eribulin in HER2 Negative Metastatic BrCa

Summary: This research study is a phase II clinical trial. Phase II clinical trials test the effectiveness of a drug to learn whether the drug works in treating a specific cancer.
  Eribulin is a chemotherapy approved by the US FDA in November of 2010 to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens. It works by interfering with cancer cell division, growth and spread.
  In this research study, the investigators are looking to see how well Eribulin helps participants with metastatic breast cancer as a first-line or second-line chemotherapy treatment. The investigators also would like to learn about the side-effects that participants experience with this medication, in particular, neuropathy.
  Neuropathy is a condition in which the nerves are affected, leading to numbness or tingling of the fingers and toes. The investigators would like to study the effect Eribulin has on the nerves through regular questionnaires that ask about any nerve-related symptoms. The investigators also plan to send blood samples to determine if gene markers may indicate increased sensitivity to the nerve effects of Eribulin.

Detailed description: If you are willing to participate in this study you will be asked to undergo some screening tests and procedures to confirm your eligibility. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. The screening tests and procedures will include: a medical history, a physical examination and vital signs, performance status, an assessment of your tumor, routine blood tests, pregnancy test and an electrocardiogram. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research.
  If you take part in this research study, you will be given Eribulin by intravenous infusion (by vein). The time to complete a single treatment is 60 minutes. You will receive Eribulin on Day 1 and Day 8 of each cycle. In the third week (Day 15) you will not receive any study medication. Each complete treatment cycle lasts 3 weeks.
  During all cycles you will have a physical exam and you will be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking.
  At the beginning of cycles 1,2,3 and every other subsequent cycle, you will be asked to complete three online questionnaires using a wireless tablet computer provided in the clinic where you are being seen. This is a well established method of administering electronic questionnaires. No data will be stored on these computers. The data will be transmitted to servers where the data will be securely stored. Your data will be submitted using a special identification number. You will be given a username and a password. You will be given detailed instructions on how to use the computer and how to enter the data. If the wireless tablet computer is not working, paper forms will be provided. It will take about 15-30 minutes to complete. Some questions you will be asked to answer may make you feel uncomfortable. You may choose not to answer any questions that make you feel uncomfortable.
  We will assess your tumor by the appropriate imaging modality (e.g., CT scan or MRI) every 9 weeks.
  About 4 tablespoons of blood will be drawn to measure blood counts, organ function, and for other safety reasons. Blood tests will be done on Day 1 and Day 8 of every treatment cycle (every three weeks). One additional tube of blood (about 1 teaspoon) will be collected at Day 1 to be used to better understand the nerve toxicities of chemotherapy and to be used for future research on breast cancer.
  You will have a follow-up visit three weeks after stopping study treatment. During that visit, you will have a physical exam, as well as an assessment of any side effects and current medications. If you continue to have on-going side effects related to your study treatment, we will continue to follow you until this side effect resolves. About 4 tablespoons of blood will be drawn to measure blood counts and organ function. If you stop therapy because of a side effect but your cancer is under control, we will continue to follow you with scans every 9 weeks until cancer growth is observed.

Eligibility: Inclusion Criteria:
  -  Histologically or cytologically proven invasive breast cancer, locally recurrent or metastatic, with at least one measureable lesion according to RECIST v1.1
  -  Hormone receptor positive or hormone receptor negative HER2-negative disease
  -  Up to one prior line of chemotherapy for advanced disease is allowed (discontinued at least 14 days prior to initiation of protocol therapy)
  -  Prior bevacizumab in the neo/adjuvant or metastatic setting is acceptable
  -  No limit on prior lines of endocrine therapy, but must be discontinued at least 7 days prior to initiation of protocol therapy
  -  Must have completed any prior radiotherapy at least 2 weeks prior to initiation of protocol therapy
  -  Must have recovered from reversible effects of prior therapies to no more than grade 1 toxicity, with the exception of alopecia
  -  Agree to use adequate contraception for the duration of study participation
  Exclusion Criteria:
  -  Pregnant or breastfeeding
  -  Prior treatment with eribulin
  -  Prior malignancy other than carcinoma in situ of the cervix or nonmelanoma skin cancer unless diagnosed and definitively treated at least 3 years before enrollment in this study
  -  Clinically significant cardiovascular impairment
  -  Active brain metastases or unevaluated neurologic symptoms suggestive of brain metastases
  -  Pulmonary dysfunction requiring the use of oxygen
  -  Prior organ allograft requiring immunosuppression
  -  HIV positive on combination antiretroviral therapy
  -  Pre-existing grade 3 or 4 neuropathy
  -  Hypersensitivity to halichondrin B or halichondrin B chemical derivative
  -  Uncontrolled intercurrent illness
  -  Inability to read in English

Relevance to patient case: not relevant