A potential local study for mom..thoughts?

[Rich66]

Protocol Summary Protocol No.E1105Principal InvestigatorCleary, James PhaseIII Age GroupAdultScopeNational Sponsor TypeNational Group TitleA Randomized Phase III Double Blind Placebo-Controlled Trial of First-Line Chemotherapy and Trastuzumab with or without Bevacizumab for Patients with HER-2/NEU Over-Expressing Metastatic Breast Cancer ObjectiveThe purpose of this study is to find out if adding an experimental medication (bevacizumab) to standard treatment increases length of survival compared to standard treatment alone. TreatmentTrastuzumab is a type of anticancer drug that is commercially available, and that has been shown to be effective in breast cancers that are positive for the protein HER-2 NEU. Bevacizumab is an investigational drug and has not yet been approved by the FDA for the treatment of breast cancer. Bevacizumab is the common name for the commercial drug Avastin. However, the bevacizumab used in this study is an investigational drug and has not yet been approved by the FDA for treatment in breast cancer. The bevacizumab that is being used in this study is for use in research studies only and may be made at locations different from those where Avastin is made.
DescriptionYou will be "randomized" into one of the study groups described below. Randomization means that you are put into a group by chance. A computer program will place you in one of the study groups. Neither you nor your study doctor can choose the group you will be in. You will have an equal chance of being placed in any group, and you and your study doctor will NOT know which group you have been placed on. You will receive trastuzumab weekly as an infusion in the vein for four weeks. You will receive chemotherapy (paclitaxel or paclitaxel and carboplatin, based on you and your study doctor's choice as an infusion in the vein every week for 3 weeks followed by a one week rest period. In addition, if you are randomized to Arm A, you will receive a placebo for bevacizumab as an infusion in the vein once every 2 weeks, or if you are randomized to Arm B, you will receive bevacizumab, an investigational agent, as an infusion in the vein once every 2 weeks. Each 4-week period will be considered one cycle of therapy. You will receive a maximum of 6 cycles (24 weeks) of trastuzumab, chemotherapy and bevacizumab or placebo. Then, for as long as your disease does not progress and you are not experiencing any intolerable side effects, you will continue to receive trastuzumab and bevacizumab or placebo once every 3 weeks, this period of time is called "maintenance therapy."
About 489 people will take part in this study, and approximately 12-24 from the University of Wisconsin and its study sites.
Key Eligibility

• Confirmed diagnosis of breast cancer
• Evidence of metastatic disease and/or chest wall recurrence
• Overexpression of HER-2
• Prior hormone treatment allowed
• No prior chemotherapy, trastuzumab or bevacizumab allowed for metastatic disease
• No CNS metastases

Applicable Disease SitesBreast Therapies InvolvedChemotherapy Drugs InvolvedAvastin (bevacizumab)
HER2/NEU (trastuzumab)
anti-pi85 her2 monoclonal antibody (trastuzumab)
bevacizumab
carboplatin
cbdca (carboplatin)
herceptin (trastuzumab)
paclitaxel
paraplatin (carboplatin)
placebo
rhu Mab VEGF (bevacizumab)
rhuMAb HER2 (trastuzumab)
taxol (paclitaxel)
trastuzumab

[StephN]

ei Rich -
Sorry your Mom's biopsy came back as mets. But, she should have more options than her oncs are allowing.

My opinion (as one who also had to fight liver mets) is that a trial where she does not know which group (means what drugs she gets) she is in may not be the best idea.

Someone her age needs to make the most of the chance she has and get drugs that have a good possibility to help her.

Navelbine is a drug that normally is fairly easy to tolerate. I know a couple of women 70 and over who have done well on it (one also had Herceptin and a hormone suppressor).

They should just get on with giving her something rather than fiddling around. Or treat the mets with ablation if the mets are in an area where this would work. (In my case tumors were not.)

I would go with weekly, and see how your dear Mom tolerates that.

[Rich66]

Current suggestion is that Theraspheres won't work because of too many tumors. Looks like you had a pretty serious situation too but the regimen cleared your liver. Do you have the sense that the combo you got is typical for heavy liver mets? I'm just trying to get at what drove your onc to pick such a successful combo.
You can direct mail me at richreilly at hotmail if you like

[Rich66]

What? FDA goes against advisory panel and approves Avastin? Is this some bizarre controversial situation?

[chrisy]

Steph,
I agree there is obviously an unknown whether or not one would be in the Avastin arm of this study. However, the chemo/herceptin arm of this trial is a pretty potent one, with either herceptin+taxol or herceptin+taxol+carboplatin.

I had the latter (T/C/H) and it was very effective against my extensive liver mets in 2004. "Fabulous response" was how my onc put it. Still, in your case, Navelbine did the trick when Taxol didn't - I guess everyone is different. Not having a Navelbine history, I can't comment on which combo is "easier" in terms of side effects.

Rich,
If your mom is now considering chemo options, Taxol/Carbo/Herceptin is a great one if she and her onc feel it would be tolerable; Taxol/Herceptin is also good and possibly less "difficult". Not sure about Navelbine as I've not had that.

And IF these are options which are at/near the top of your list, even the chance to get Avastin with it would be a good opportunity. Studies show that the earlier you get Avastin, the more effective it is likely to be. Worst case, your mom would be getting a (cancer) killer standard of care regimen.

[Sheila]

Rich
Avastin is a marvelous drug....I was on it for 6 months and had an excellent response when it was added to Taxol and Herceptin....BUT, my B/P became very high and even with medication was over the limits....also, my insurance company denied payment after all the controversy with approval. This may not be the best drug for your Mom considering she has emphysema....I agree with Steph that there might be something better and more tolerable.

[StephN]

Hi everyone -

My combo for liver mets included BOTH Navelbine and Taxol, along with Herceptin.

This was a new trial at the time. What was interesting about it was that both Navelbine and Taxol have shown to be effective agents against liver mets, and that if a patient was HER+ Herceptin would be added.

A one-two-three punch.

Navelbine with Xeloda has also shown to be good against liver mets.

Good luck!

[Rich66]

Please keep commenting folks.

[Lori R]

Rich,
Yet another option to consider.
From the posts on this site, it appears that that Taxotere, Carbo, Herceptin is a frequently used cocktail.

As you know, I WAS (thinking positive) a liver mets gal and my onc used only Taxotere and Herceptin. I asked her as to why no Carbo. She indicated that the Carbo can be very damaging to the immune system and she's had success without the Carbo.

While I am not 100% sure about how I feel about not going for the gusto (other than bc I am a VERY healthy 50), I respect her opinion and also respect the concern about too much Chemo.

I just share this as an option that has worked for me that might be a little easier for your mom to tolerate.

Could you pull together a list of all these options and review the pros/cons with you mom's onc? If you aren't comfortable with the quality of the responses ....time for a new onc.

I realize it is sooooo much to consider and the stakes seem so high. One approach is to review the options, TAKE THE PLUNGE!!! If it isn't working, quickly shift gears. This process holds no guarantees so I don't know that there is a RIGHT decision, just the best one at the time.

Best of luck to you....you are a fantastic son.

[Rich66]

Thanks folks. Though my head continues to skim the clouds for latest, greatest...somethng will have to be done soon. mom's meeting with current onc is on the 18th(Thur). Keep it coming.