S1207 Clincal Trial: Anyone in this trial?

peacestrength

Anyone currently in this clinical trial?

Clinical Trial:

S1207: Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu Negative Breast Cancer.

Detailed Description:

OBJECTIVES:

Primary

• To compare whether the addition of one year of everolimus (10 mg daily) to standard adjuvant endocrine therapy improves invasive disease-free survival (IDFS) in patients with high-risk, hormone-receptor (HR)-positive, and human epidermal growth factor receptor (HER)2-negative breast cancer.

Secondary

• To compare whether the addition of one year of everolimus to standard adjuvant endocrine therapy improves overall survival (OS) and distant recurrence-free survival (DRFS) in this patient population.
• To evaluate the safety, toxicities, and tolerability of one year of everolimus in combination with standard adjuvant endocrine therapy and to compare it with standard adjuvant endocrine therapy plus placebo in this patient population.
• To determine whether the benefit of one year of everolimus use in addition to standard adjuvant endocrine therapy varies by recurrence score (RS), nodal status, or other commonly used prognostic factors.
• To evaluate adherence to 1-year treatment of everolimus in comparison to placebo in addition to standard adjuvant endocrine therapy in this patient population.
• To collect specimens in order to evaluate biomarkers of therapeutic efficacy. (exploratory)

OUTLINE: This is a multicenter study. Patients are stratified according to risk level (node-negative and recurrence score [RS] > 25 in the primary tumor, and a tumor measuring ≥ 2 cm in greatest diameter treated with adjuvant therapy vs 1-3 positive lymph nodes and RS > 25 treated with adjuvant therapy vs ≥ 4 positive lymph nodes [any RS value] treated with adjuvant therapy vs ≥ 4 positive lymph nodes [any RS value] prior to or after neoadjuvant chemotherapy). Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive an approved endocrine therapy comprising tamoxifen citrate*, goserelin acetate** or leuprolide acetate**, or aromatase inhibitor (anastrozole, letrozole, or exemestane) for 2-5 years. Patients also receive a placebo orally (PO) daily for 1 year in the absence of disease progression or unacceptable toxicity.
• Arm II: Patients receive an approved endocrine therapy regimen as in arm I. Patients also receive everolimus PO daily for 1 year in the absence of disease progression or unacceptable toxicity.

NOTE: *Men receive tamoxifen citrate PO for 5 years.

NOTE: **Goserelin acetate or leuprolide acetate is given if patient is or becomes postmenopausal.

Blood and tissue samples are collected for biomarker studies.

After completion of study treatment, patients are followed up every 6 months for 2 years and then yearly thereafter for 10 years.

peacestrength

This trial just opened in October 2013 in Wisconsin and I'm thinking about completing it. It says, "Not Recruiting" on ClinicalTrials.gov but I found out through my MO that it is recruiting in my area now. I received the consent information and could start it in two weeks.

Anyone currently in this trial?

JennaJMU

what do they mean by recurrence score? Is that Oncotype score?

peacestrength

Yes, I believe it's the Oncotype score.

sbelizabeth

I just looked it up on Google. It looks like it might be open for applicants at USC here in So Cal. I'm going to call tomorrow and inquire into it.

Gitane

Since you have had chemo, I'm assuming chemo is allowed. I didn't read "chemo" above, but for high risk patients, I can't imagine a trial without it. The only other question I might have is whether they would allow you to take more than 5 years of endocrine therapy. That may be a consideration for you. The SE's of Everolimus can be a bit rough. I think it inhibits your immune system. What is your oncologist saying?

peacestrength

Gitane -  Good questions. Yes, one has to have completed standard of care to be considered for this trial - chemo, sugery, radiation, and be on Tamox or an AI.  The study is taking Everolimus/Afinitor or placebo for a year.  If it shows promise, they switch everyone over to the real drug.  This drug was approved for metastatic b/c and they now want to test it for other stages of b/c.  So not sure about being on this drug for 5 years - time will tell.

Yes, Afinitor has side effects that can lower immunity - I have a few weeks to make a decision. 

My MO is completely on board with this.

mary625

I Googled and found random sites around the country, nothing near me. Anybody know of places around DC, Philadelphia, NYC, etc.? Seattle? How does one make sure to get into this when it opens?

mary625

I finally found that it's open at Fox Chase Cancer Center in Philadelphia. However, I got a message today that participants have to be within 21 weeks of ending chemo. If that's the case, it's a "no go" for me.

peacestrength

Mary625 - I'm going to check this out.  When I talked to the study coordinator,  she said one has to be at least 21 days post radiation or further and on antiestrogens. Did you talk to someone in person?  

peacestrength

Mary625 - I just found out that one DOES have to be within 21 weeks after completion of chemotherapy.   Darn - I wish this wasn't the case for you.

mary625

Thanks, Peacestrength. It is a very LONG list of qualifications for this study indeed. Apparently, it is also a difficult drug to take, but I think I would have been willing to do so. Wonder how that works in a placebo trial.

Warrior50

what do you google to find the trial? I am still in chemo but looking for something after treatment to reduce chance of recurrence.

TectonicShift

.

Warrior50

thanks Techtonic!

mrachlinski

Hi,

I mostly lurk on this site, but I am going to participate in this trial.  I have an appointment to sign consents and do labs in early Feb in NYC (Collumbia/Pres). My oncologist was very enthusiastic about this treatment. 

melissa

peacestrength

Great, Melissa!  

yogamama

Melissa, I've just begun this trail. I'm trying to figure out if I've got the placebo arm or not. Let me know if you experience any noticeable side effects, once you start the meds. I have some things, but nothing severe enough to be sure. Julee