HER2 medical ethics question

[AlaskaAngel]

Early stage NED HER2+++'s barred from participating in the Herceptin trial are prevented from documenting whether Herceptin would help prevent recurrence, and can only get Herceptin off-label -- yet those newly diagnosed with identical (or even less critical) cancer characteristics are given Herceptin. Is this medically responsible or ethical? Will results of this off-label use at least be clearly documented?

[mumbo]

My mum has 2nd stage metastic breast cancer,. It is in her liver and bones she is on chemo but it is not suitable for her as she is reacting to it. I have talked to her about increasing her immune system, alkalining her body and increasing the oxygen uptake to her body to help fight off her cancers.
Has anyone here heard of or is using/has good results using cellular zeolite a mineral compound that helps mop up heavy metals viruses and bacteria.

[AlaskaAngel]

To clarify, I was not asking about the ethical effect on the individual, I was asking about the ethics of preventing the affected group of people from access to the right to document whether or not treatment with trastuzumab is a reasonable medical practice, while providing that right to the newly diagnosed and those who have metastasized. I appreciate your explanation of role of the pharmaceutical company and the FDA. What is the role of the research oncologists who are not part of either the pharmaceutical company or the FDA?

[CCF-RN,MSN-rf]

Dear AlaskaAngel: Herceptin (trastuzumab) has been approved by the FDA for treatment of metastatic breast cancer that overexpresses HER-2. Recent studies have shown benefit with the use of Herceptin in earlier stages of breast cancer (women with HER-2 positive breast cancer for both node negative and node positive breast cancer) for prolonged disease-free survival. Both premenopausal and postmenopausal women participated in these trials demonstrating benefit. The current information indicates benefit with Herceptin treatment for one year, but studies are ongoing to determine if 2 years of treatment are also beneficial. There is no evidence that the patient