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any clinical trials open for tnbc "maintenance"?

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hummingbird10 View Drop Down
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    Posted: Jun 28 2012 at 8:45pm
Anyone who has specific information of trials that
are really accessible (without long waiting lists and
medical contact persons who never reply) for tnbc
patients who are looking for something AFTER
treatment, please post here.
I appreciate any and all help with this.
Hummingbird
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Grateful for today Quote  Post ReplyReply Direct Link To This Post Posted: Jun 29 2012 at 2:36am
Hi Hummingbird,

Looks like most of the clinical trials are for those who had residual disease.......those who had
chemo first, then surgery with some residual disease found at time of surgery.   Most of those
clinical trials have certain Stage requirements and time requirements. Time requirements being
usually from last treatment date or from the surgery date. Thus, it is very important for anyone
considering a clinical trial for residual disease to find out ASAP how long one has to be eligible
for a residual disease study.


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Some of the clinical trials for residual disease (with Stage and time criteria) are:

PARP Inhibition for Triple Negative Breast Cancer (ER-/PR-/HER2-)With BRCA1/2 Mutations
(with Residual Disease)    NCT01074970
http://clinicaltrials.gov/ct2/show/NCT01074970?term=breast+cancer+++residual+disease&rank=9

Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy   NCT01401959
http://clinicaltrials.gov/ct2/show/NCT01401959?term=breast+cancer+++residual+disease&rank=10

Bevacizumab, Metronomic Chemotherapy (CM), Diet and Exercise After Preoperative Chemotherapy for Breast Cancer (ABCDE)   NCT00925652
http://clinicaltrials.gov/ct2/show/NCT00925652?term=breast+cancer+++residual+disease&rank=11

Oral Microencapsulated Diindolylmethane in Treating Patients With Stage II-III Triple Negative, Androgen Receptor Positive Breast Cancer Who Have Undergone Chemotherapy and Surgery NCT01612910
http://clinicaltrials.gov/ct2/show/NCT01612910?term=breast+cancer+++residual+disease&rank=6
Addendum 8/8/12: Clinical trial NCT01612910 is now suspended. Drugs unavailable.
====================================================

Other clinical trial post treatment with no residual disease requirement but does have
Stage and time criteria::

A Phase III Randomized Trial of Metformin vs Placebo in Early Stage Breast Cancer   NCT01101438
http://clinicaltrials.gov/ct2/show/NCT01101438?term=breast+cancer+++metformin&rank=6
Note: There are other metformin clinical trials connected with surgery and chemo.

=====================================================

For other clinical trials, go to : http://clinicaltrials.gov/ct2/search
   and put in criteria of trial one is looking for.

For additional information on metformin: see prior TNBC forum threads:
    http://forum.tnbcfoundation.org/using-metformin_topic7990_page10.html
    http://forum.tnbcfoundation.org/metformin-clinical-trail-info_topic7434_post100249.html?KW=metformin+trials#100249
    http://forum.tnbcfoundation.org/asking-questions-on-metformin-trial_topic9079.html?KW=metformin
****Note:   There were/are some members who either were not near a metformin trial site or had
                    passed the eligibility period.   Some member have received metformin "off label" from
                    their oncologists or primary care physicians.    If one considers this off label use of
                    metformin, be sure to show the physician the clinical trial inclusion and exclusion
                    criteria and be aware of the special considerations when on metformin per one's
                    physician ( for example, monitoring kidney function, special precautions before
                    hospital admissions/surgery/ tests with contrast dyes etc.)
                    Some oncologists and primary care physicians will not consider metformin unless it is
                    part of a clinical trial.

============================================================

We are all aware of the importance of nutrition and exercise.
In fact, if one was in the clinical trial NCT:00925652, one may have been randomized into the
        diet or diet/exercise arm of the trial. (other arms had chemo)
See:   http://onlinelibrary.wiley.com/doi/10.3322/caac.21142/full
           Nutritional and activity guidelines for cancer survivors.   April 2012.
           See various Exercise and nutrition threads on the TNBC forum via search.
As usual, nutrition and exercise plans per review with one's physician.

There is also the good information on VItamin D on the thread: (see esp. page 26)
      http://forum.tnbcfoundation.org/vitamin-d3_topic5338_page26.html
If one does not know their vitamin D3 level, have it tested. Then if the Vitamin D3 level is
low, one can discuss plan to raise it (with Vitamin D3) with one's physician.


With caring and positive thoughts,
Grateful for today............Judy

Edited by Grateful for today - Aug 08 2012 at 3:40pm
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Post Options Post Options   Thanks (0) Thanks(0)   Quote hummingbird10 Quote  Post ReplyReply Direct Link To This Post Posted: Jul 06 2012 at 8:28pm
Judy,
I just realized your posting for me. It is wonderful, so complete.
I appreciate it.  I'm thinking the Metformin via the Primary Care might
be a possibility. I don't meet the time criteria for the trial.
I am getting my D3 retested as it was very low. Am taking supplements.
Hummingbird
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Grateful for today Quote  Post ReplyReply Direct Link To This Post Posted: Jan 26 2013 at 3:00pm
Bumping for new members.    Please see above post of June 29, 2012




Grateful for today...........Judy

Edited by Grateful for today - Jan 26 2013 at 3:01pm
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