Confused: Need help if my mom can participate in clinical trial

kirankamble

Hi,

My mom has been diagnosed with HER 2 positive metastatic breast cancer.

But the research department of the hospital are insisting her to participate in clinical trial for a drug DRL_TZ similar to Herceptin along with weekly Paclitaxel. This is randomized study so 50% patients will get DRL_TZ and some Herceptin.

The benefit is no cost on our part and she would be given this chemo target therapy for 24 weeks.

But the down side is ifshe is being deprived of some other treatments like mastectomy in the process.

Should we go for clinical trial? I am confused and need help. its urgent.

Moderators

Hi kirankamble, welcome to Breastcancer.org. We're sorry for your mom's diagnosis but glad you found us! We hope these articles from our main site help you find some answers while you wait for responses from other members here:

• Benefits and Risks of Participating in a Clinical Trial
• What Should I Know Before I Decide to Be Part of a Clinical Trial?

These forums may be also of interest for you to read and/or post:

• Clinical Trials, Research Studies, News, and Study Results
• For Family and Caregivers of Members with STAGE IV Diagnosis

Let us know if she finally gets enrolled in the clinical trial.

Best wishes,

The Mods

kirankamble

Thank you so much for you response. Will keep posted if i enroll her.

JCS28

Do you have any other details about the trial? Would they be monitoring her, so that if it the disease progressed, they would stop and change treatment? Would they definitely schedule mastectomy for after the 24 weeks?

I did a trial, but it was different. My options were standard of care (taxotere, carboplatin, herceptin, perjeta) every 3 weeks for 6 rounds. The trial option was herceptin and perjeta ONLY every 3 weeks for 4 rounds, then surgery, then 6 rounds of chemo. I chose the trial, and I had a great response.

Does your doctor have a recommendation? I really trust my doctor and talked to both my oncologist and my breast surgeon, and they both thought the trial was good for me. I'm not saying that it's good for you. I'm just saying if you trust your doctor, hopefully you can feel good about your decision.

kirankamble

Thanks JCS28. The trial is for a proposed biosimilar drug to Herceptin.

She would be given 4mg/Kg(first day on fisrt dose of study)DRL_TZ or Herceptin followed by 2mg/Kg weekly in combination with paclitaxel 80mg/mg2 for upyo 24 weeks.

It appeares to me that my doctor is more interested in getting a subject for the biosimilar drug study than treatment of my mom. So not much comfortable.

Hopeful82014

I'm very sorry about your mom's situation, Kirankamble.

Is there a possibility that she could get a second opinion at another clinic or institution?

JCS28

Yes, I would get a second opinion from somewhere, especially if you suspect this doctor just wants to recruit patients. Have you met with any other doctors like a surgeon who could also offer advice? Or maybe a friend? Or another hospital?

lkc

Hi There . I have worked on clinical trials and can give you some info.

Most importantly she should be comfortable with her choice and not be pressured

First thing is ask for the informed consent to take home and read. They have to give it to you. Make sure all is understood and if not ask questions.

The clinical trials start with Phase one and then yhe phsae goes up in number. goes up. Example is phase III is the last phase before the drug gets submitted to the FDA for approval. You will find all the safety information gathered on previous trials with this med in the informed consent.

Second, a mastectomy is not an option if the mets are located beyond the axilla, lung, liver etc.since the treatment needs to be systemic.

you can also go to clinical trial.gov and search for the trial, Just put in breast cancer and the new drug identifier.

Lastly, if your mom gets into the trial will closely track her. She can discontinue being in the trial at any time for any reason.

They'll allow her to continue the trial if her metastatic lesion (s) stay the same or get smaller. If they gets larger they will discontinue her from the trial. so she can get a different treatment.

Hope that helps. I wish her well.

kirankamble

JCS28..Yes i have gone for second opinion and awaiting their feedback. Thank you for your wishes.

kirankamble

Lkc...Thank you so much for addressing the concerns which I had especially the mastectomy option.

As far as i know the trial is in Phase 3 so i reckon the risks may be reduced.

I have opted for second opinion too. So with that and your response i will certainly be more confident in arriving at a decision.

Thank you so much you response was indeed useful.