IMPORTANT from New England Journal of Medicine (June 1, 2017)

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Hanging_in_there
Hanging_in_there Member Posts: 226

This is important for TNBC. This just came out, and here is the abstract link

This is about Xeloda

http://www.nejm.org/doi/full/10.1056/NEJMoa1612645

Due to this outcome from a week ago, they changed a trial for TNBC so that the control group gets Xeloda and the experimental group gets Xeloda and (Carboplatin or Cisplatin) Patient and doctor together choose which of those two drugs you get, if in experimental group.

This is the clinical trial that just changed:

Chemo After Neoaduvant Chemo and Surgery for Basal-Like Triple-Negative Breast Cancer

A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy vs. Observation in Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy (EA1131) (NCT02445391)

Summary

Most triple-negative breast cancers have basal-like qualities, meaning the cells resemble the basal cells that line the breast ducts. Neoadjuvant chemotherapy (treatment given before surgery) is used to shrink the tumor before surgery. Sometimes the tumor will disappear completely. In other instances, the tumor can be seen during surgery. Cisplatin (Platinol®) and carboplatin (Paraplatin®) are platinum-based chemotherapy drugs that laboratory studies suggest may be effective against basal-like triple-negative breast cancer. This study will investigate whether giving one of these chemotherapy drugs after surgery reduces the risk of recurrence in patients with basal-like triple negative breast cancer who had neoadjuvant therapy that did not make their tumor disappear. Participants will have their tumor specimens tested for basal-like qualities.
This is a Phase III trial

What's involved:

Participants will be randomly assigned to 1 of 2 groups:

Group 1: Experimental

  • Cisplatin (Platinol®) or Carboplatin (Paraplatin®) by IV, every 3 weeks

Group 2: No intervention

  • Observation



Additional procedures:

Please contact research site

Trial length:

3 months

Post-trial follow-up:

Up to 10 years

Sponsor:

NCI;Other

More information

View eligibility criteria and additional trial information:


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So repeating myself,

Control group gets Xeloda (not just observation - which is why I was not interested in this trial until yesterday)

Experimental group gets Xeloda plus either Carboplatin or Cisplatin)

I just talked to a doctor who is doing this study in Baltimore on June 7, so the information is really new!

I expect to join this study. There are 598 sites where they are doing this clinical trial.


I got to this trial by filling out all my data at Breastcancertrials.org. I suggest you save it and log in, because if you don't you lose it when you close the window. I did that and had to re-type in all those pages of the form.

Of course you can get it on Clinicaltrials.gov, but Breastcancertrials.org picks out trials that are likely appropriate to you.


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